What you need to know about drugs

Pamelor

Pamelor(nortriptyline hcl) – Mallinckrodt

BOXED WARNING

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Monitor and observe closely for clinical worsening, suicidality, or unusual changes in behavior in patients who are started on antidepressant therapy. Nortriptyline is not approved for use in pediatric patients.

THERAPEUTIC CLASS

Tricyclic antidepressant

INDICATIONS

Relief of symptoms of depression.

ADULT DOSAGE

Adults: 25mg tid-qid. Max: 150mg/day. Total daily dose may be given once a day. Monitor serum levels if dose >100mg/day. Elderly/Adolescents: 30-50mg/day in single or divided doses.

HOW SUPPLIED

Cap: 10mg, 25mg, 50mg, 75mg; Sol: 10mg/5mL

CONTRAINDICATIONS

MAOI use within 14 days, acute recovery period following MI.

WARNINGS/PRECAUTIONS

MI, arrhythmia, strokes have occurred. Caution with cardiovascular disease (CVD), glaucoma, history of urinary retention, hyperthyroidism. May lower seizure threshold, exacerbate psychosis or activate schizophrenia, cause symptoms of mania in bipolar disease, or alter glucose levels. D/C several days prior to elective surgery.

ADVERSE REACTIONS

Arrhythmias, hypotension, HTN, tachycardia, MI, heart block, stroke, confusion, hallucination, insomnia, tremors, ataxia, dry mouth, blurred vision, skin rash.

DRUG INTERACTIONS

See Contraindications. May block guanethidine effects. Arrhythmia risk with thyroid agents. Alcohol may potentiate effects. "Stimulating" effect with reserpine. Monitor with anticholinergic and sympathomimetic drugs. Increased plasma levels with cimetidine. Hypoglycemia reported with chlorpropamide. SSRIs, antidepressants, phenothiazines, propafenone, flecainide and CYP2D6 inhibitors (eg, quinidine) may potentiate effects. Decreased clearance with quinidine.

PREGNANCY

Safety during pregnancy and nursing not known.

MECHANISM OF ACTION

Tricyclic antidepressant; inhibits activity of histamine, 5-hydroxytryptamine, and acetylcholine; increases pressor effect of NE, blocks pressor response of phenethylamine, and interferes with transport, release, and storage of catecholamine.

ASSESSMENT

Assess for acute recovery period after MI, bipolar disorder risk, history of mania, unrecognized/history of schizophrenia, possible drug interactions, history of seizures, CVD, hyperthyroidism, DM, glaucoma, urinary retention, history of agitation or overactivity, and pregnancy/nursing status.

MONITORING

Periodically monitor blood glucose. Monitor for signs/symptoms of clinical worsening (suicidality, unusual changes in behavior), mania, cardiovascular events, increasing psychosis, increasing anxiety/agitation, mydriasis, hypo/hyperglycemia, seizures, cognitive/motor impairment.

PATIENT COUNSELING

Advise to avoid alcohol. Seek medical attention for symptoms of activation of mania, seizures, clinical worsening (suicidal ideation, unusual changes in behavior), cardiovascular events, increasing psychosis, increasing anxiety/agitation, mydriasis, and hypo/hyperglycemia. May impair physical/mental abilities.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 20-25°C (68-77°F).


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    Pamelor

    Pamelor

    Pronunciation Generic Name: nortriptyline (nor TRIP ti leen)

    Brand Name: Pamelor

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Pamelor (nortriptyline)?

    Nortriptyline is a tricyclic antidepressant. Nortriptyline affects chemicals in the brain that may become unbalanced.

    Nortriptyline is used to treat symptoms of depression.

    Nortriptyline may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about Pamelor (nortriptyline)?

    You should not take this medication if you have recently had a heart attack, or if you are allergic to nortriptyline or to similar antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, protriptyline, or trimipramine.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    Do not use nortriptyline if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

    Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

    What should I discuss with my healthcare provider before taking Pamelor (nortriptyline)?

    You should not take this medication if you have recently had a heart attack, or if you are allergic to nortriptyline or to similar antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, protriptyline, or trimipramine.

    Do not use nortriptyline if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

    To make sure nortriptyline is safe for you, tell your doctor if you have:

    • heart disease, or a history of heart attack, stroke, or seizures;

    • a family history of sudden death related to a heart rhythm disorder;
    • bipolar disorder (manic-depression);
    • schizophrenia or other mental illness;
    • liver disease;
    • a thyroid disorder;
    • diabetes (nortriptyline may raise or lower blood sugar);
    • glaucoma;
    • problems with urination; or
    • if you are being treated with methylene blue injection.

    Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using nortriptyline. Your family or other caregivers should also be alert to changes in your mood or symptoms.

    It is not known whether nortriptyline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

    It is not known whether nortriptyline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

    Older adults may be more likely to have side effects from this medication.

    Do not give this medicine to a child without medical advice.

    How should I take Pamelor (nortriptyline)?

    Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

    If you need surgery, tell the surgeon ahead of time that you are using nortriptyline. You may need to stop using the medicine for a short time.

    Do not stop using nortriptyline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using nortriptyline.

    It may take up to a few weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve during treatment.

    Store at room temperature away from moisture and heat.

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of nortriptyline can be fatal.

    What should I avoid while taking Pamelor (nortriptyline)?

    Do not drink alcohol. Nortriptyline can increase the effects of alcohol, which could be dangerous.

    Grapefruit and grapefruit juice may interact with nortriptyline and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

    This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    Avoid exposure to sunlight or tanning beds. Nortriptyline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

    Pamelor (nortriptyline) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

    Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

    Call your doctor at once if you have:

    • a feeling like you might pass out;

    • new or worsening chest pain, pounding heartbeats or fluttering in your chest;
    • sudden numbness or weakness, problems with vision, speech, or balance;
    • fever, sore throat;
    • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
    • agitation, hallucinations, overactive reflexes, confusion, unusual thoughts or behavior;
    • restless muscle movements in your eyes, tongue, jaw, or neck;
    • painful or difficult urination;
    • seizure (convulsions); or
    • upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes).

    Common side effects may include:

    • tingly feeling, weakness, lack of coordination;

    • dry mouth, unpleasant taste, nausea, constipation;
    • blurred vision, ringing in your ears;
    • breast swelling (in men or women); or
    • decreased sex drive, impotence, or difficulty having an orgasm.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Pamelor side effects (in more detail)

    What other drugs will affect Pamelor (nortriptyline)?

    Taking nortriptyline with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking nortriptyline with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

    Before taking nortriptyline, tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline.

    You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can take nortriptyline.

    Many drugs can interact with nortriptyline. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with nortriptyline, especially:

    • bupropion;

    • cimetidine;
    • reserpine;
    • St. John’s wort;
    • terbinafine;
    • any other anti-depressant, or medication to treat mental illness;
    • bladder or urinary medicines–darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
    • bronchodilators–ipratropium, tiotropium;
    • cold or allergy medicine that contains an antihistamine;
    • medication for Parkinson’s disease;
    • medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
    • a decongestant (pseudoephedrine, phenylephrine), diet pills, stimulant medication; or
    • heart rhythm medications–flecainide, propafenone, or quinidine.

    This list is not complete and many other drugs can interact with nortriptyline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

    Next Page → Side Effects

    More Pamelor resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 23 Reviews - Add your own review/rating
    • Generic Availability
    • Pamelor Prescribing Information (FDA)
    • Pamelor MedFacts Consumer Leaflet (Wolters Kluwer)
    • Pamelor Monograph (AHFS DI)
    • Pamelor Advanced Consumer (Micromedex) – Includes Dosage Information
    • Nortriptyline Prescribing Information (FDA)

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    Where can I get more information?

    • Your pharmacist can provide more information about nortriptyline.

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    Pamelor

    Pamelor

    Pronunciation Generic Name: nortriptyline hydrochloride

    Dosage Form: capsule

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Pamelor™

    (nortriptyline HCl) capsules USP

    (nortriptyline HCl) oral solution USP

    Rx only

    Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nortriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride is not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use).

    Pamelor Description

    Pamelor™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d] cyclohepten-5-ylidene)-N-methyl-, hydrochloride.

    The structural formula is as follows:

    10 mg, 25 mg, 50 mg, and 75 mg Capsules

    Active Ingredient: nortriptyline hydrochloride USP.

    10 mg, 25 mg, and 75 mg Capsules

    Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.

    50 mg Capsules

    Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.

    Solution

    Active Ingredient: nortriptyline hydrochloride USP.

    Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.

    Pamelor – Clinical Pharmacology

    The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Pamelor is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that Pamelor interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that Pamelor has a combination of stimulant and depressant properties.

    Indications and Usage for Pamelor

    Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

    Contraindications

    Monoamine Oxidase Inhibitors (MAOIs)

    The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome.  The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).

    Starting Pamelor in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).

    Hypersensitivity to Tricyclic Antidepressants

    Cross-sensitivity between Pamelor and other dibenzazepines is a possibility.

    Myocardial Infarction

    Pamelor is contraindicated during the acute recovery period after myocardial infarction.

    Warnings

    Clinical Worsening and Suicide Risk

    Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

    The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

    Table 1
     Age Range  Drug-Placebo Difference in

    Number of Cases of Suicidality

    per 1000 Patients Treated

     Increases Compared to Placebo
     <18  14 additional cases
     18-24  5 additional cases
     Decreases Compared to Placebo
     25-64  1 fewer case
     ≥65  6 fewer cases

    No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

    It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

    All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

    The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

    Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

    Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for nortriptyline hydrochloride should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.

    Screening Patients for Bipolar Disorder – A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that nortriptyline hydrochloride is not approved for use in treating bipolar depression.

    Patients with cardiovascular disease should be given Pamelor only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred. The antihypertensive action of guanethidine and similar agents may be blocked. Because of its anticholinergic activity, Pamelor should be used with great caution in patients who have glaucoma or a history of urinary retention. Patients with a history of seizures should be followed closely when Pamelor is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if Pamelor is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.

    Pamelor may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly.

    Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation.

    The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline.

    Serotonin Syndrome

    The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Pamelor, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

    Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

    The concomitant use of Pamelor with MAOIs intended to treat psychiatric disorders is contraindicated. Pamelor should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Pamelor. Pamelor should be discontinued before initiating treatment with the MAOI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).

    If concomitant use of Pamelor with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

    Treatment with Pamelor and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

    Use in Pregnancy

    Safe use of Pamelor during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.

    Precautions

    Information for Patients

    Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with nortriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for nortriptyline hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

    Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking nortriptyline hydrochloride.

    Clinical Worsening and Suicide Risk – Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

    The use of Pamelor in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic-depressive patients, Pamelor may cause symptoms of the manic phase to emerge.

    Troublesome patient hostility may be aroused by the use of Pamelor.  Epileptiform seizures may accompany its administration, as is true of other drugs of its class.

    When it is essential, the drug may be administered with electroconvulsive therapy, although the hazards may be increased. Discontinue the drug for several days, if possible, prior to elective surgery.

    The possibility of a suicidal attempt by a depressed patient remains after the initiation of treatment; in this regard, it is important that the least possible quantity of drug be dispensed at any given time.

    Both elevation and lowering of blood sugar levels have been reported.

    Drug Interactions

    Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients.

    Close supervision and careful adjustment of the dosage are required when Pamelor is used with other anticholinergic drugs and sympathomimetic drugs.

    Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.

    A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).

    Drugs Metabolized by P450 2D6 – The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).

    In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

    Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

    Monoamine Oxidase Inhibitors (MAOIs)

    (See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)

    Serotonergic Drugs

    (See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)

    Pediatric Use

    Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS, Clinical Worsening and Suicide Risk). Anyone considering the use of nortriptyline hydrochloride in a child or adolescent must balance the potential risks with the clinical need.

    Geriatric Use

    Clinical studies of Pamelor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience indicates that, as with other tricyclic antidepressants, hepatic adverse events (characterized mainly by jaundice and elevated liver enzymes) are observed very rarely in geriatric patients and deaths associated with cholestatic liver damage have been reported in isolated instances. Cardiovascular function, particularly arrhythmias and fluctuations in blood pressure, should be monitored. There have also been reports of confusional states following tricyclic antidepressant administration in the elderly. Higher plasma concentrations of the active nortriptyline metabolite, 10-hydroxynortriptyline, have also been reported in elderly patients. As with other tricyclic antidepressants, dose selection for an elderly patient should usually be limited to the smallest effective total daily dose (see DOSAGE AND ADMINISTRATION).

    Adverse Reactions

    Note – Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered.

    Cardiovascular – Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.

    Psychiatric – Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis.

    Neurologic – Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus.

    Anticholinergic – Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

    Allergic – Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs.

    Hematologic – Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia.

    Gastrointestinal – Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue.

    Endocrine – Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.

    Other – Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia.

    Withdrawal Symptoms – Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

    Overdosage

    Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible.

    Manifestations

    Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.

    Other signs of overdose may include: confusion, restlessness, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the acute symptoms listed under ADVERSE REACTIONS. There have been reports of patients recovering from nortriptyline overdoses of up to 525 mg.

    Management

    General – Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.

    Gastrointestinal Decontamination – All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. EMESIS IS CONTRAINDICATED.

    Cardiovascular – A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH >7.60 or a pCO2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide). In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.

    CNS – In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.

    Psychiatric Follow-up – Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

    Pediatric Management – The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

    Pamelor Dosage and Administration

    Pamelor is not recommended for children.

    Pamelor is administered orally in the form of capsules or liquid. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.

    If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.

    Usual Adult Dose – 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.

    Elderly and Adolescent Patients 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.

    Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

    At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Pamelor. Conversely, at least 14 days should be allowed after stopping Pamelor before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

    Use of Pamelor With Other MAOIs, Such as Linezolid or Methylene Blue

    Do not start Pamelor in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

    In some cases, a patient already receiving Pamelor therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Pamelor should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Pamelor may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

    The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Pamelor is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

    How is Pamelor Supplied

    Pamelor™ (nortriptyline HCl) Capsules USP

    Pamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:

    10 mg:      Light orange opaque cap printed “

    Pamelor 10 mg” in black and white opaque body printed “

    ” in black.      Bottles of 30………………NDC 0406-9910-03

    25 mg:      Light orange opaque cap printed “

    Pamelor 25 mg” in black and white opaque body printed “

    “ in black.      Bottles of 30………………NDC 0406-9911-03

    50 mg:      White opaque cap printed “

    Pamelor 50 mg” in black and white opaque body printed “

    ” in black.      Bottles of 30………………NDC 0406-9912-03

    75 mg:      Light orange opaque cap printed “

    Pamelor 75 mg” in black and light orange opaque body printed “

    ” in black.      Bottles of 30………………NDC 0406-9913-03

    Store and Dispense

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Dispense in tight container (USP) with a child-resistant closure.

    Pamelor™ (nortriptyline HCl) Oral Solution USP

    Pamelor™ (nortriptyline HCl) oral solution USP, equivalent to 10 mg base per 5 mL, is supplied in 16-fluid-ounce bottles (NDC 0406-9918-16). Alcohol content 4%.

    Store and Dispense

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Dispense in tight, light-resistant container.

    Pamelor and 

    are trademarks of Mallinckrodt LLC. Capsules manufactured by:

    Patheon Inc.

    Whitby, Ontario, Canada

    L1N 5Z5

    Oral Solution manufactured by:

    Novartis Consumer Health, Inc.

    Lincoln, Nebraska 68517

    Manufactured for:

    Mallinckrodt Inc.

    Hazelwood, MO 63042 USA

    Medication Guide – Pamelor™ (nortriptyline HCl) Capsules USP and Oral Solution USP

    Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

    Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

    • all risks and benefits of treatment with antidepressant medicines
    • all treatment choices for depression or other serious mental illness

    What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

    1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
    2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
    3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
      • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
      • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
      • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

     
    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling very agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
     
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in behavior or mood

    Who should not take Pamelor?

    Do not take Pamelor if you:

    •  take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
      •  Do not take an MAOI within 2 weeks of stopping Pamelor unless directed to do so by your physician.
      • Do not start Pamelor if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

    What else do I need to know about antidepressant medicines?

    • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
    • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
    • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
    • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
    • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Pamelor is a trademark of Mallinckrodt LLC.

    Capsules manufactured by:

    Patheon Inc.

    Whitby, Ontario, Canada

    L1N 5Z5

    Oral Solution manufactured by:

    Novartis Consumer Health, Inc.

    Lincoln, Nebraska 68517

    Manufactured for:

    Mallinckrodt Inc.

    Hazelwood, MO 63042 USA

    COVIDIEN™

    Mallinckrodt

    Rev 10/2012

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 mg Bottle

    NDC 0406-9910-03

    30 Capsules

    Pamelor™

    (nortriptyline HCl)

    capsules USP

    equivalent to

    10 mg

    base

    Rx only

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE

    Mallinckrodt

    USUAL DOSAGE:

    See package insert.

    STORAGE:

    Store at 20º to 25ºC (68º to 77º F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP) with a child-resistant closure.  Do not accept if seal over bottle opening is broken or missing.

    Manufactured by Pantheon Inc.

    Whitby, Ontario, Canada L1N5Z5

    for Mallinckrodt Inc.

    Hazelwood, MO 63042 USA

    COVIDIEN™

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 25 mg Bottle

    NDC 0406-9911-03

    Pamelor™

    (nortriptyline HCl)

    capsules USP

    equivalent to

    25 mg

    base

    Rx only

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE

    Mallinckrodt

    USUAL DOSAGE:

    See package insert.

    STORAGE:

    Store at 20º to 25ºC (68º to 77º F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP) with a child-resistant closure.  Do not accept if seal over bottle opening is broken or missing.

    Manufactured by Pantheon Inc.

    Whitby, Ontario, Canada L1N5Z5

    for Mallinckrodt Inc.

    Hazelwood, MO 63042 USA

    COVIDIEN™

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 mg Bottle

    NDC 0406-9912-03

    Pamelor™

    (nortriptyline HCl)

    capsules USP

    equivalent to

    50 mg

    base

    Rx only

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE

    Mallinckrodt

    USUAL DOSAGE:

    See package insert.

    STORAGE:

    Store at 20º to 25ºC (68º to 77º F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP) with a child-resistant closure.  Do not accept if seal over bottle opening is broken or missing.

    Manufactured by Pantheon Inc.

    Whitby, Ontario, Canada L1N5Z5

    for Mallinckrodt Inc.

    Hazelwood, MO 63042 USA

    COVIDIEN™

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 75 mg Bottle

    NDC 0406-9913-03

    30 Capsules

    Pamelor™

    (nortriptyline HCl)

    capsules USP

    equivalent to

    75 mg

    base

    Rx only

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE

    Mallinckrodt

    USUAL DOSAGE:

    See package insert.

    STORAGE:

    Store at 20º to 25ºC (68º to 77º F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP) with a child-resistant closure.  Do not accept if seal over bottle opening is broken or missing.

    Manufactured by Pantheon Inc.

    Whitby, Ontario, Canada L1N5Z5

    for Mallinckrodt Inc.

    Hazelwood, MO 63042 USA

    COVIDIEN™

    Pamelor 

    nortriptyline hydrochloride capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-9910
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE) NORTRIPTYLINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    DIMETHICONE 350  
    STARCH, CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE (light orange) , WHITE Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code Pamelor;10;mg;M
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0406-9910-03 30 CAPSULE (30 CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018013 08/03/2010
    Pamelor 

    nortriptyline hydrochloride capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-9911
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE) NORTRIPTYLINE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    DIMETHICONE 350  
    STARCH, CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE (light orange) , WHITE Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code Pamelor;25;mg;M
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0406-9911-03 30 CAPSULE (30 CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018013 08/03/2010
    Pamelor 

    nortriptyline hydrochloride capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-9912
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE) NORTRIPTYLINE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN  
    DIMETHICONE 350  
    STARCH, CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code Pamelor;50;mg;M
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0406-9912-03 30 CAPSULE (30 CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018013 08/03/2010
    Pamelor 

    nortriptyline hydrochloride capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-9913
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE) NORTRIPTYLINE 75 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    DIMETHICONE 350  
    STARCH, CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE (light orange) Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code Pamelor;75;mg;M
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0406-9913-03 30 CAPSULE (30 CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018013 08/03/2010
    Labeler - Mallinckrodt, Inc. (047021092)
    Establishment
    Name Address ID/FEI Operations
    Patheon Inc. 205475333 ANALYSIS(0406-9910, 0406-9911, 0406-9912, 0406-9913), LABEL(0406-9910, 0406-9911, 0406-9912, 0406-9913), MANUFACTURE(0406-9910, 0406-9911, 0406-9912, 0406-9913)

    Revised: 10/2012   Mallinckrodt, Inc.

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    Pamelor

    Pamelor

    Pronunciation Generic Name: nortriptyline (nor-TRIP-ti-leen)

    Brand Name: Examples include Aventyl and Pamelor

    Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient’s doctor to be sure that the benefits of using Pamelor outweigh the risks.

    Family and caregivers must closely watch patients who take Pamelor. It is important to keep in close contact with the patient’s doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient’s doctor.

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    Pamelor is used for:

    Treating depression. It may also be used for other conditions as determined by your doctor.

    Pamelor is a tricyclic antidepressant. It works by increasing the activity of certain chemicals in the brain that help elevate mood.

    Do NOT use Pamelor if:

    • you are allergic to any ingredient in Pamelor or to similar medicines
    • you have taken furazolidone, linezolid, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days, or you are taking astemizole, droperidol, or terfenadine
    • you are recovering from a recent heart attack

    Contact your doctor or health care provider right away if any of these apply to you.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    Before using Pamelor:

    Some medical conditions may interact with Pamelor. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you drink alcohol-containing beverages daily or you have a history of alcohol abuse
    • if you take thyroid medicine or you have a history of overactive thyroid, glaucoma, heart problems, kidney or liver problems, diabetes, seizures, the blood disease porphyria, or difficulty urinating
    • if you have a history of suicidal thoughts or behavior, bipolar disorder, or any other mental disorders; you are undergoing electroshock therapy; or you are scheduled to have any surgery
    • if you are taking a medicine that contains methylene blue

    Some MEDICINES MAY INTERACT with Pamelor. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Azole antifungals (eg, fluconazole), cimetidine, duloxetine, flecainide, methylphenidate, mibefradil, phenothiazines (eg, chlorpromazine), propafenone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or terbinafine because they may increase the risk of Pamelor’s side effects
    • Arsenic, astemizole, droperidol, furazolidone, linezolid, MAOIs (eg, phenelzine), pimozide, quinolone antibiotics (eg, ciprofloxacin), streptogramins (eg, dalfopristin), terfenadine, or tramadol because the risk of high blood pressure, serious heart problems (eg, irregular heartbeat), or seizures may be increased
    • Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Pamelor’s effectiveness
    • Anticholinergics (eg, benztropine), carbamazepine, chlorpropamide, or sympathomimetics (eg, phenylephrine) because the risk of their side effects may be increased by Pamelor
    • Clonidine, guanethidine, or guanfacine because their effectiveness may be decreased by Pamelor

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Pamelor may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Pamelor:

    Use Pamelor as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Pamelor comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pamelor refilled.
    • Take Pamelor by mouth with or without food.
    • If you miss a dose of Pamelor, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.

    Ask your health care provider any questions you may have about how to use Pamelor.

    Important safety information:

    • Pamelor may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pamelor with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pamelor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
    • Pamelor may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
    • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
    • Children, teenagers, and young adults who take Pamelor may be at increased risk for suicidal thoughts or actions. Watch all patients who take Pamelor closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
    • Pamelor may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pamelor. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
    • Tell your doctor or dentist that you take Pamelor before you receive any medical or dental care, emergency care, or surgery.
    • Lab tests, including blood cell counts, may be performed while you use Pamelor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • Use Pamelor with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, blood pressure changes, and irregular heartbeat.
    • Pamelor should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: It is not known if Pamelor can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pamelor while you are pregnant. It is not known if Pamelor is found in breast milk. Do not breast-feed while taking Pamelor.

    If you stop taking Pamelor suddenly, you may have WITHDRAWAL symptoms. These may include headache, nausea, and tiredness.

    Possible side effects of Pamelor:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; bluish skin or mucous membranes; breathing problems; chest pain; coma; confusion; dry mouth; enlarged pupils; excess sweating; fainting; fast or irregular heartbeat; flushing; incoordination; involuntary movements; loss of consciousness; restlessness; rigid muscles; seizures; severe drowsiness; shock; stupor; trouble breathing; vomiting.

    Proper storage of Pamelor: Store Pamelor at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pamelor out of the reach of children and away from pets.

    General information:

    • If you have any questions about Pamelor, please talk with your doctor, pharmacist, or other health care provider.
    • Pamelor is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Pamelor or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pamelor. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pamelor. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Pamelor.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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    Pamelor

    Pamelor

    Pronunciation Generic Name: nortriptyline (Oral route)

    nor-TRIP-ti-leen

    OverviewSide EffectsInteractionsFor ProfessionalsMore… Oral route(Capsule;Solution) Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

    Commonly used brand name(s)

    In the U.S.

    • Aventyl
    • Pamelor

    Available Dosage Forms:

    • Tablet
    • Capsule
    • Solution

    Therapeutic Class: Antidepressant

    Pharmacologic Class: Antidepressant, Tricyclic

    Uses For Pamelor

    Nortriptyline is used to treat the symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. This medicine is a tricyclic antidepressant (TCA) .

    This medicine is available only with your doctor’s prescription .

    Before Using Pamelor

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of nortriptyline in the pediatric population. Safety and efficacy have not been established .

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nortriptyline in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose for patients receiving nortriptyline .

    Breast Feeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bepridil
    • Cisapride
    • Clorgyline
    • Dronedarone
    • Grepafloxacin
    • Isocarboxazid
    • Levomethadyl
    • Linezolid
    • Mesoridazine
    • Methylene Blue
    • Metoclopramide
    • Moclobemide
    • Phenelzine
    • Pimozide
    • Ranolazine
    • Selegiline
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Tranylcypromine

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acecainide
    • Alfuzosin
    • Almotriptan
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amoxapine
    • Amprenavir
    • Apomorphine
    • Aprindine
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Azimilide
    • Azithromycin
    • Bretylium
    • Chloral Hydrate
    • Chloroquine
    • Chlorpromazine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clomipramine
    • Clonidine
    • Clozapine
    • Crizotinib
    • Dasatinib
    • Desipramine
    • Dextromethorphan
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Domperidone
    • Droperidol
    • Enflurane
    • Epinephrine
    • Erythromycin
    • Etilefrine
    • Fingolimod
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Foscarnet
    • Gatifloxacin
    • Gemifloxacin
    • Granisetron
    • Halofantrine
    • Haloperidol
    • Halothane
    • Hydroxytryptophan
    • Ibutilide
    • Iloperidone
    • Imipramine
    • Indacaterol
    • Iproniazid
    • Isoflurane
    • Isradipine
    • Lapatinib
    • Levofloxacin
    • Lidoflazine
    • Lopinavir
    • Lorcainide
    • Lorcaserin
    • Lumefantrine
    • Mefloquine
    • Methadone
    • Methoxamine
    • Midodrine
    • Mifepristone
    • Moricizine
    • Moxifloxacin
    • Nefopam
    • Nialamide
    • Nilotinib
    • Norepinephrine
    • Norfloxacin
    • Octreotide
    • Ofloxacin
    • Ondansetron
    • Oxilofrine
    • Paliperidone
    • Pargyline
    • Pazopanib
    • Pentamidine
    • Perflutren Lipid Microsphere
    • Phenylephrine
    • Posaconazole
    • Procainamide
    • Procarbazine
    • Prochlorperazine
    • Promethazine
    • Propafenone
    • Protriptyline
    • Quetiapine
    • Quinidine
    • Quinine
    • Rasagiline
    • Risperidone
    • Saquinavir
    • Sematilide
    • Sertindole
    • Sertraline
    • Sodium Phosphate
    • Sodium Phosphate, Dibasic
    • Sodium Phosphate, Monobasic
    • Solifenacin
    • Sorafenib
    • Sotalol
    • Spiramycin
    • Sulfamethoxazole
    • Sultopride
    • Sunitinib
    • Tapentadol
    • Tedisamil
    • Telavancin
    • Telithromycin
    • Tetrabenazine
    • Toloxatone
    • Toremifene
    • Tramadol
    • Trazodone
    • Trifluoperazine
    • Trimethoprim
    • Trimipramine
    • Vandetanib
    • Vardenafil
    • Vasopressin
    • Vemurafenib
    • Venlafaxine
    • Voriconazole
    • Ziprasidone
    • Zolmitriptan
    • Zotepine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acenocoumarol
    • Arbutamine
    • Atomoxetine
    • Bupropion
    • Carbamazepine
    • Cimetidine
    • Dicumarol
    • Paroxetine
    • Phenprocoumon
    • Rifapentine
    • S-Adenosylmethionine
    • Terbinafine
    • Valproic Acid

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
    • Heart attack, recent—Should not be used in patients with these conditions .
    • Diabetes or
    • Glaucoma or
    • Heart disease or
    • Overactive thyroid or
    • Schizophrenia or
    • Seizures, history of or
    • Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse .

    Proper Use of nortriptyline

    This section provides information on the proper use of a number of products that contain nortriptyline. It may not be specific to Pamelor. Please read with care.

    Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered .

    Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup .

    This medicine comes with a medication guide. Read and follow the instructions in the guide carefully. Ask your doctor if you have any questions .

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage forms (capsules or solution):
      • For depression:
        • Adults—25 milligrams (mg) three to four times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg per day.
        • Teenagers and Older Adults—30 to 50 milligrams (mg) once a day or in divided doses during the day.
        • Children—Use and dose must be determined by your doctor .

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Precautions While Using Pamelor

    It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects .

    Nortriptyline may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away .

    Do not take nortriptyline if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 5 days of stopping nortriptyline. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions .

    Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness .

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

    Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking nortriptyline together with medicines used during surgery may increase the risk of side effects .

    This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor .

    This medicine may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert.

    Pamelor Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Incidence not known

    • Abdominal or stomach pain
    • actions that are out of control
    • agitation
    • anxiety
    • black, tarry stools
    • bleeding and bruising
    • bleeding gums
    • blood in urine or stools
    • blurred vision
    • burning, crawling, itching, numbness, prickling, “pins and needles” , or tingling feelings
    • chest pain or discomfort
    • clay-colored stools
    • cold sweats
    • coma
    • confusion about identity, place, and time false beliefs that cannot be changed by facts
    • continuing ringing or buzzing or other unexplained noise in ears
    • convulsions
    • cool, pale skin
    • cough or hoarseness
    • dark urine
    • decrease in frequency of urination
    • decreased urine output or volume
    • depression
    • difficulty in passing urine [dribbling]
    • difficulty in speaking
    • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    • double vision
    • drooling
    • dry mouth
    • fast, pounding, or irregular heartbeat or pulse
    • fear or nervousness
    • feeling of warmth
    • feeling, seeing, or hearing things that are not there
    • feeling that others are watching you or controlling your behavior
    • feeling that others can hear your thoughts
    • fever with or without chills
    • flushed, dry skin
    • fruit-like breath odor
    • general feeling of tiredness or weakness
    • headache
    • hearing loss
    • hostility
    • hyperventilation
    • inability to move arms, legs, or facial muscles
    • inability to speak
    • increased hunger
    • increased need to urinate
    • increased thirst
    • increased urination
    • irritability
    • itching
    • lack of coordination
    • lethargy
    • loss of appetite
    • loss of balance control
    • lower back or side pain
    • mood or mental changes
    • muscle spasm or jerking of all extremities
    • muscle trembling, jerking, or stiffness
    • muscle twitching
    • nausea
    • nightmares
    • pain or discomfort in arms, jaw, back, or neck
    • painful or difficult urination
    • panic
    • passing urine more often
    • perspiration
    • pinpoint red or purple spots on skin
    • pounding in the ears
    • rapid weight gain
    • rash
    • redness of the face, neck, arms and occasionally, upper chest
    • restlessness
    • seizures
    • shakiness and unsteady walk
    • shortness of breath
    • shuffling walk
    • sleeplessness
    • slow speech
    • slurred speech
    • sore throat
    • sores, ulcers, or white spots on lips or in mouth
    • stiffness of limbs
    • stupor
    • sudden loss of consciousness
    • sweating
    • swelling of face, ankles, legs or hands
    • swollen glands
    • talking, feeling, and acting with excitement
    • trouble in holding or releasing urine
    • trouble sleeping
    • twisting movements of body uncontrolled movements, especially of face, neck, and back
    • unable to sleep
    • unpleasant breath odor
    • unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
    • unusual behavior
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting of blood
    • weakness in arms, hands, legs, or feet
    • weight gain or loss
    • yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of Overdose

    • Blue lips and fingernails
    • change in consciousness
    • clumsiness
    • cold clammy skin
    • coughing that sometimes produces a pink frothy sputum
    • decreased awareness or responsiveness
    • difficult, fast, or noisy breathing, sometimes with wheezing
    • difficulty sleeping
    • dilated neck veins
    • disorientation
    • disturbed concentration
    • drowsiness to profound coma
    • enlarged pupils
    • extreme fatigue
    • fast, weak pulse
    • hallucination
    • increased or excessive unconscious or jerking movements
    • increased sweating
    • irregular breathing
    • loss of consciousness
    • low body temperature
    • muscle aches
    • muscle weakness
    • pale skin
    • severe sleepiness
    • shivering
    • sleepiness
    • swelling in legs and ankles
    • tightness in chest
    • trouble breathing
    • weak or feeble pulse
    • wheezing

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Abdominal cramps
    • bigger, dilated, or enlarged pupils (black part of eye)
    • black tongue
    • bloating
    • decreased interest in sexual intercourse
    • diarrhea
    • difficulty having a bowel movement (stool)
    • disturbance of accommodation
    • enlargement of the breast
    • hair loss, thinning of hair
    • heartburn
    • hives or welts
    • inability to have or keep an erection
    • increased in sexual ability, desire, drive, or performance
    • increased interest in sexual intercourse
    • increased sensitivity of eyes to light
    • increased sensitivity of skin to sunlight
    • increased urge to urinate during the night
    • loss in sexual ability, desire, drive, or performance
    • pain or discomfort in chest, upper stomach, or throat
    • peculiar taste
    • redness or other discoloration of skin
    • severe sunburn
    • small red or purple spots on skin
    • swelling of testicles
    • swelling of the breasts or breast soreness in both females and males
    • swelling or inflammation of the mouth
    • swollen, painful, or tender lymph glands on side of face or neck
    • unexpected or excess milk flow from breasts
    • waking to urinate at night

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Pamelor side effects (in more detail)

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    Pamelor

    Pamelor

    Pronunciation Generic Name: Nortriptyline Hydrochloride
    Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors

    VA Class: CN601

    CAS Number: 894-71-3

    For ProfessionalsSide EffectsInteractionsMore…

    Warning(s)

    • Suicidality
    • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.h i Nortriptyline is not approved for use in pediatric patients.a (See Pediatric Use under Cautions.)
    • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.h i
    • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.h i j
    • Appropriately monitor and closely observe all patients who are started on nortriptyline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.h i j (See Worsening of Depression and Suicidality Risk under Cautions.)

    Introduction

    Tricyclic antidepressant (TCA);a active metabolite of amitriptyline.d

    Uses for Pamelor

    Major Depressive Disorder

    Management of major depressive disorder.a

    Results of several studies of TCAs in preadolescent and adolescent patients with major depression indicate lack of overall efficacy in this age group.

    Attention Deficit Hyperactivity Disorder

    Second-line agent in attention deficit hyperactivity disorder† (ADHD) patients unable to tolerate or unresponsive to stimulants; should be used only under close supervision.b

    Associated with a narrower margin of safety than some other therapeutic agents; use only if clearly indicated and with careful monitoring, including baseline and subsequent determinations of ECG and other parameters.

    Eating Disorders

    Has been used for management of eating disorder† (e.g., bulimia†, anorexia nervosa†) with equivocal results; avoid use in underweight individuals and in those exhibiting suicidal ideation.b

    Smoking Cessation

    Second-line agent for the management of nicotine (tobacco) dependence† in patients who received first-line drugs (e.g., bupropion [as extended-release tablets], nicotine polacrilex gum, transdermal nicotine) but were not able to quit smoking or in whom these drugs are contraindicated.

    Bipolar Disorder

    Has been used for the short-term management of acute depressive episodes in bipolar disorder†.b e

    TCAs associated with a greater risk of precipitating hypomania or manic episodes than other classes of antidepressants;e should always be used in combination with a mood stabilizer (e.g., lithium).e

    Schizophrenia

    Has been used for the management of acute depressive episodes (in combination with an antipsychotic) in patients with schizophrenia†.b

    Anxiety Disorders

    Has been used for the management of anxiety† (in combination with anxiolytics, sedatives, or antipsychotics) in patients with depression.b

    Postherpetic Neuralgia

    Among the drugs of choice for the symptomatic treatment of postherpetic neuralgia†.b

    Insomnia

    Less effective for insomnia† and associated with more serious adverse reactions than conventional hypnotics.b

    Pamelor Dosage and Administration

    General

    • Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of nortriptyline and vice versa.a Also allow at least 5 weeks to elapse when switching from fluoxetine.a

    • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.a h i j (See Worsening of Depression and Suicidality Risk under Cautions.)
    • Sustained therapy may be required; monitor periodically for need for continued therapy.a
    • Avoid abrupt discontinuance in patients receiving high dosages for prolonged periods.a b To avoid withdrawal reactions, taper dosage gradually.a b

    Administration

    Oral Administration

    Administer orally in up to 4 divided doses or as a single daily dose.a

    Dosage

    Available as nortriptyline hydrochloride; dosage is expressed in terms of nortriptyline.a

    Adults

    Major Depressive Disorder
    Oral

    Initially, 25 mg daily.g Gradually adjust to level that produces maximal therapeutic effects (up to 200 mg daily).d

    Usual dosage: Manufacturer recommends 75–100 mg daily, but some experts state usual dosage range is 50–200 mg daily.a g After symptoms are controlled, dosage should be gradually reduced to the lowest level that will maintain relief of symptoms.d

    Hospitalized patients under close supervision may generally be given higher dosages than outpatients.d

    Smoking Cessation†
    Oral

    25 mg daily, and then gradually increase to a target dosage of 75–100 mg daily.104

    Initiate nortriptyline therapy 10–28 days before date set for cessation of smoking.104

    Nortriptyline was continued for approximately 12 weeks in clinical studies.104

    Prescribing Limits

    Adults

    Major Depressive Disorder
    Oral

    Manufacturer does not recommend dosages >150 mg daily, but higher dosages (e.g., 200 mg daily) have been used.a g

    Special Populations

    Geriatric Patients

    30–50 mg daily.a

    Cautions for Pamelor

    Contraindications

    • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.a (See Specific Drugs under Interactions.)

    • During the acute recovery phase following MI.a
    • Known hypersensitivity to nortriptyline, other dibenzazepine-derivative TCAs, or any ingredient in the formulation.a

    Warnings/Precautions

    Warnings

    Worsening of Depression and Suicidality Risk

    Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients, whether or not they are taking antidepressants; may persist until clinically important remission occurs.h i j k However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.h i j

    Appropriately monitor and closely observe patients receiving nortriptyline for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.h i j (See Boxed Warning and also see Pediatric Use under Cautions.)

    Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.i j Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.h i j

    Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.a i

    Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.i

    Bipolar Disorder

    May unmask bipolar disorder.i (See Activation of Mania or Hypomania under Cautions.) Nortriptyline is not approved for use in treating bipolar depression.a

    Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.i

    Cardiovascular Effects

    Possible arrhythmias, sinus tachycardia, prolongation of the conduction time, MI, and stroke.a

    Patients with preexisting cardiac disease and patients with disturbed eating behaviors (e.g., purging) that result in inadequate hydration and/or compromised cardiac status most at risk;b monitor closely.a

    Interactions

    May block hypotensive actions of guanethidine and similar agents.a

    May enhance effects of alcohol.a Use with caution in patients with a history of excessive alcohol consumption.a (See Interactions.)

    Possible pharmacokinetic (increased systemic exposure to nortriptyline) interaction with quinidine.a

    Anticholinergic Effects

    Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased intraocular pressure, angle-closure glaucoma).a b

    Seizures

    Risk of seizures; use with caution in patients with a history of seizures.a

    Hyperthyroidism

    Possible development of cardiac arrhythmias; use with caution and under close supervision in hyperthyroid patients or patients receiving thyroid agents.a

    Cognitive/Physical Impairment

    Performance of activities requiring mental alertness and physical coordination may be impaired.a

    Sensitivity Reactions

    Cross-hypersensitivity

    Possible cross-sensitivity to other dibenzazepine-derivative TCAs (e.g., clomipramine, desipramine, trimipramine).a

    Photosensitivity

    Avoid excessive exposure to sunlight.a

    General Precautions

    Activation of Mania or Hypomania

    Possible activation of mania and hypomania, particularly in patients with bipolar disorder;a decrease dosage and/or administer an antipsychotic agent (e.g., perphenazine) concomitantly.e (See Bipolar Disorder under Cautions.)

    Increased anxiety, agitation, and hostility also may occur, particularly when administered to overactive or agitated patients.a

    Psychosis

    Risk of manifestations of psychosis in patients with schizophrenia.a

    Electroconvulsive Therapy (ECT)

    Possible increased ECT risks; limit to patients for whom concomitant use is essential.a

    Elective Surgery

    Discontinue therapy several days prior to surgery whenever possible.a

    Blood Glucose Effects

    Possible alterations in blood glucose concentrations.a

    Specific Populations

    Pregnancy

    Category D.f Possible cardiovascular or limb reduction anomalies.f

    Lactation

    Distributes into milk;100 101 102 use not recommended.a f

    Pediatric Use

    Not effective in management of depression in children† or adolescents in clinical studies; manufacturer states not recommended for use in children <18 years of age.a

    FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).i However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.k No suicides occurred in these pediatric trials.i k

    Carefully consider these findings when assessing potential benefits and risks of nortriptyline in a child or adolescent for any clinical use.h i j k (See Worsening of Depression and Suicidality Risk under Cautions.)

    Geriatric Use

    Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.a

    In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.h i (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

    Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, hepatic (e.g., elevated liver enzymes, jaundice),a orthostatic hypotension, and sedative effects of TCAs. Monitor carefully, particularly for cardiovascular toxicity (e.g., arrhythmias, fluctuations in BP).a

    Titrate dosage carefully. (See Geriatric Patients under Dosage and Administration.)

    Hepatic Impairment

    Use with caution.a

    Common Adverse Effects

    Anticholinergic effects (e.g., dry mouth,b constipation,b vision disturbance),b orthostatic hypotension,b sedation,b weakness,b lethargy,b fatigue.b

    Interactions for Pamelor

    Metabolized in the liver by various CYP isoenzymes (e.g., CYP1A2, CYP2C, CYP2D6, CYP3A4).b

    Drugs Affecting Hepatic Microsomal Enzymes

    Inhibitors of CYP2D6: Potential pharmacokinetic interaction (increased nortriptyline concentrations).a Adjust nortriptyline dosage whenever a CYP2D6 inhibitor is added or discontinued.a

    Specific Drugs

    Drug

    Interaction

    Comments

    Alcohol

    Potentiates the effects of alcohola

    Increased risks if overdose or suicide attempt occursa

    Antiarrhythmics: class 1C (e.g., flecainide, propafenone); quinidine

    Potential for decreased nortriptyline metabolisma

    Possible increased plasma nortriptyline concentrations and prolonged half-life when quinidine administered concomitantlya

    Monitor for TCA toxicitya

    Anticholinergic agents

    Hyperthermia, particularly during hot weather, and paralytic ileusb

    Use with caution; dosage adjustment may be neededa

    Anticoagulants (e.g., warfarin)

    Possible increased PTb

    Antipsychotics (e.g., phenothiazines)

    Potential for decreased nortriptyline metabolismb

    Use with cautionb

    Chlorpropamide

    Substantial hypoglycemia possiblea

    Cimetidine

    Potential for decreased nortriptyline metabolisma

    Hypotensive agents (e.g., guanethidine)

    Antagonizes the antihypertensive effects of guanethidinea

    Levodopa

    May interfere with levodopa absorptionb

    Monitor levodopa dosage carefullyb

    MAO inhibitors

    Potentially life-threatening serotonin syndromea

    Concomitant use contraindicateda

    Allow at least 14 days to elapse when switching to or from these drugsa

    Reserpine

    Possible stimulating effect in depressed patientsa

    SSRIs (e.g., fluoxetine, paroxetine, sertraline)

    Possible serotonin syndromea

    Potential for decreased nortriptyline metabolism and increased plasma concentrationsa

    Use with caution; monitor for TCA toxicitya

    Allow at least 5 weeks to elapse when switching from fluoxetinea

    Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)

    Increased vasopressor, cardiac effectsb

    Use with caution; dosage adjustment may be requiredb

    Thyroid agents

    Possible cardiac arrhythmiasa

    Use with caution and under close supervisiona

    Pamelor Pharmacokinetics

    Absorption

    Bioavailability

    Peak plasma concentrations occur within 7–8.5 hours after oral administration.d

    Onset

    Antidepressant effects may not be evident for ≥2 weeks.b

    Plasma Concentrations

    Optimal antidepressant effect may be associated with plasma concentrations of 50–150 ng/mL.103

    Distribution

    Extent

    Distributes into milk;100 101 102 nortriptyline concentrations in milk appear to be similar to or slightly greater than those present in maternal serum.101 102

    Elimination

    Metabolism

    Extensively metabolized in the liver via demethylation by various CYP isoenzymes (e.g., CYP1A2, CYP2D6, CYP3A4, CYP2C).b

    Elimination Route

    Excreted principally in urine (33% within 24 hours) as inactive metabolites; small amounts are also excreted in feces via biliary elimination.d

    Half-life

    Plasma half-life ranges from 16 to >90 hours.d

    Stability

    Storage

    Oral

    Capsules and Oral Solution

    Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).a

    Actions

    • Mechanism of action in the management of depression unknown but may involve inhibition of reuptake of norepinephrine and/or serotonin.a b

    • Associated with more frequent anticholinergic, sedative, or cardiovascular effects and weight gain than SSRIs.b

    Advice to Patients

    • Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.h i j FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.h i j

    • Importance of considering possible impaired ability to perform hazardous activities (e.g., operating machinery, driving a motor vehicle).a
    • Importance of patients understanding that it may take more than 2 weeks before the full effects are apparent.a d
    • Importance of avoiding alcohol-containing beverages or products.a
    • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.a
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or planned surgery.a
    • Importance of informing patients of other important precautionary information.a (See Cautions.)

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Nortriptyline Hydrochloride
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    Capsules

    10 mg (of nortriptyline)*

    Nortriptyline Hydrochloride Capsules

    Mylan, Teva, Watson

    Pamelor (with benzyl alcohol and parabens)

    Mallinckrodt

    25 mg (of nortriptyline)*

    Nortriptyline Hydrochloride Capsules

    Mylan, Teva, Watson

    Pamelor (with benzyl alcohol and parabens)

    Mallinckrodt

    50 mg (of nortriptyline)*

    Nortriptyline Hydrochloride Capsules

    Mylan, Teva, Watson

    Pamelor (with benzyl alcohol parabens and sodium bisulfite)

    Mallinckrodt

    75 mg (of nortriptyline)*

    Nortriptyline Hydrochloride Capsules

    Mylan, Teva

    Pamelor (with benzyl alcohol and parabens)

    Mallinckrodt

    Solution

    10 mg (of nortriptyline) per 5 mL*

    Nortriptyline Hydrochloride Oral Solution

    Pharmaceutical Associates, Ranbaxy

    Pamelor (with alcohol 4%)

    Mallinckrodt

    Comparative Pricing

    This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

    Nortriptyline HCl 10MG Capsules (WATSON LABS): 90/$22.99 or 180/$33.97

    Nortriptyline HCl 10MG/5ML Solution (PHARMACEUTICAL ASSOCIATES): 473/$53.99 or 1419/$150.99

    Nortriptyline HCl 25MG Capsules (TEVA PHARMACEUTICALS USA): 30/$12.99 or 60/$15.98

    Nortriptyline HCl 50MG Capsules (WATSON LABS): 30/$19.99 or 60/$28.97

    Nortriptyline HCl 75MG Capsules (WATSON LABS): 30/$19.99 or 60/$28.97

    Pamelor 10MG Capsules (MALLINCKRODT): 30/$695.99 or 90/$2,029.97

    Pamelor 25MG Capsules (MALLINCKRODT): 30/$695.99 or 90/$2,029.97

    Pamelor 75MG Capsules (MALLINCKRODT): 30/$541.01 or 90/$1,451.01

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    † Use is not currently included in the labeling approved by the US Food and Drug Administration.

    References

    100. Roche Products Inc. Endep prescribing information. In: Huff BB, ed. Physicians’ desk reference. 39th ed. Oradell, NJ: Medical Economics Company Inc; 1985:1711-2.

    101. Brixen-Rasmussen L, Halgrener J, Jorgensen A. Amitriptyline and nortriptyline excretion in human breast milk. Psychopharmacology. 1982; 76:94-5. [PubMed 6805016]

    102. Bader TF, Newman K. Amitriptyline in human breast milk and the nursing infant’s serum. Am J Psychiatry. 1980; 137:855-6. [IDIS 117830] [PubMed 7386673]

    103. American Psychiatric Association Task Force on the Use of Laboratory Tests in Psychiatry. Tricyclic antidepressants—blood level measurements and clinical outcome: an APA Task Force Report. Am J Psychiatry. 1985; 142:155-62. [IDIS 195887] [PubMed 3881999]

    104. Fiore MC, Bailey WC, Cohen SJ et al. Treating tobacco use and dependence: clinical practice guideline. Rockville, MD: US Department of Health and Human Service. 2000 Jun.

    105. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website: ().

    106. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA web site: ().

    107. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA web site: ().

    a. Mallinckrodt Inc., Pamelor (nortriptyline hydrochloride) capsules and oral solution prescribing information. St. Louis, MO; 2001 Oct 11.

    b. AHFS drug information 2004. McEvoy GK, ed. Tricyclic antidepressants general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2234-41.

    d. AHFS drug information 2004. McEvoy GK, ed. Nortriptyline hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2256-7.

    e. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder (revised). Am J Psychiatry. 2002; 159(suppl):1-49.

    f. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and lactation. 5th ed. Baltimore, MD: Williams & Wilkins; 2002:693-4.

    g. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000; 150(Suppl 4):1-45.

    h. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site:

    i. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site:

    j. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site:

    k. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]

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    Pamelor

    Pamelor

    Pronunciation Generic Name: nortriptyline (nor TRIP ti leen)

    Brand Name: Pamelor

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Pamelor (nortriptyline)?

    Nortriptyline is in a group of drugs called tricyclic antidepressants. Nortriptyline affects chemicals in the brain that may become unbalanced.

    Nortriptyline is used to treat symptoms of depression.

    Nortriptyline may also be used for other purposes not listed in this medication guide.

    What is the most important information I should know about Pamelor (nortriptyline)?

    Do not use nortriptyline if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

    Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

    What should I discuss with my healthcare provider before taking Pamelor (nortriptyline)?

    Do not use this medication if you are allergic to nortriptyline, or if you have recently had a heart attack.

    Do not use nortriptyline if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take nortriptyline before the MAO inhibitor has cleared from your body.

    Before taking nortriptyline, tell your doctor if you are allergic to any drugs, or if you have:

    • heart disease;

    • a history of heart attack, stroke, or seizures;
    • bipolar disorder (manic-depression);
    • schizophrenia or other mental illness;
    • diabetes (nortriptyline may raise or lower blood sugar);
    • overactive thyroid;
    • glaucoma; or
    • problems with urination.

    If you have any of these conditions, you may need a dose adjustment or special tests to safely take nortriptyline.

    You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

    Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

    This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

    It is not known whether nortriptyline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    Older adults may be more likely to have side effects from this medication.

    Do not give this medication to anyone under 18 years old without the advice of a doctor.

    How should I take Pamelor (nortriptyline)?

    Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

    If you need to have any type of surgery, tell the surgeon ahead of time that you are taking nortriptyline. You may need to stop using the medicine for a short time.

    Do not stop using nortriptyline without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects.

    It may take a few weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment with nortriptyline.

    Store nortriptyline at room temperature away from moisture and heat.

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention if you think you have used too much of this medicine. An overdose of nortriptyline can be fatal.

    Overdose symptoms may include extreme drowsiness, confusion, agitation, hallucinations, blurred vision, vomiting, muscle stiffness, feeling hot or cold, fainting, seizure (convulsions), or coma.

    What should I avoid while taking Pamelor (nortriptyline)?

    Avoid drinking alcohol. It can cause dangerous side effects when taken together with nortriptyline.

    Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by nortriptyline.

    Grapefruit and grapefruit juice may interact with nortriptyline. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

    Nortriptyline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

    Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Nortriptyline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

    Pamelor (nortriptyline) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

    Call your doctor at once if you have any of these serious side effects:

    • fast, pounding, or uneven heart rate;

    • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
    • sudden numbness or weakness, especially on one side of the body;
    • sudden headache, confusion, problems with vision, speech, or balance;
    • confusion, hallucinations, or seizure (convulsions);
    • easy bruising or bleeding, unusual weakness;
    • restless muscle movements in your eyes, tongue, jaw, or neck;
    • tremors;
    • extreme thirst with headache, nausea, vomiting, and weakness;
    • feeling light-headed or fainting; or
    • urinating less than usual or not at all.

    Less serious side effects may include:

    • nausea, vomiting, stomach pain, loss of appetite;

    • constipation or diarrhea;
    • weight changes;
    • dry mouth, unpleasant taste;
    • weakness, lack of coordination;
    • numbness or tingly feeling;
    • blurred vision, headache, ringing in your ears;
    • mild skin rash;
    • breast swelling (in men or women); or
    • increased sweating.

    This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Pamelor side effects (in more detail)

    What other drugs will affect Pamelor (nortriptyline)?

    Before taking nortriptyline, tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

    Before taking nortriptyline, tell your doctor if you are currently using any of the following drugs:

    • cimetidine (Tagamet);

    • guanethidine (Ismelin);
    • reserpine; or
    • heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

    This list is not complete and there are many other medicines that can interact with nortriptyline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

    Next Page → Side Effects

    More Pamelor resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 23 Reviews - Add your own review/rating
    • Generic Availability
    • Pamelor Prescribing Information (FDA)
    • Pamelor MedFacts Consumer Leaflet (Wolters Kluwer)
    • Pamelor Monograph (AHFS DI)
    • Pamelor Advanced Consumer (Micromedex) – Includes Dosage Information
    • Nortriptyline Prescribing Information (FDA)

    Compare Pamelor with other medications

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    • Primary Nocturnal Enuresis
    • Reflex Sympathetic Dystrophy Syndrome
    • Smoking Cessation
    • Tinnitus
    • Vulvodynia

    Where can I get more information?

    • Your pharmacist can provide more information about nortriptyline.

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