What you need to know about drugs

Focalin

Focalin(dexmethylphenidate hcl) – Novartis

BOXED WARNING

Caution with history of drug dependence or alcoholism. Marked tolerance and psychological dependence with varying degrees of abnormal behavior may occur with chronic abusive use. Frank psychotic episodes may occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal after chronic use may unmask symptoms of underlying disorder that may require follow-up.

THERAPEUTIC CLASS

Sympathomimetic amine

INDICATIONS

Treatment of attention-deficit hyperactivity disorder (ADHD).

ADULT DOSAGE

Adults: Individualize dose. Take bid, at least 4 hrs apart. Methylphenidate-Naive: Initial: 5mg/day (2.5mg bid). Titrate: May adjust weekly in 2.5-5mg increments. Max: 20mg/day (10mg bid). Currently on Methylphenidate: Initial: 1/2 of methylphenidate dose. Max: 20mg/day (10mg bid). Reduce or d/c if paradoxical aggravation of symptoms or other adverse events occur. D/C if no improvement seen after appropriate dosage adjustment over 1 month.

PEDIATRIC DOSAGE

Pediatrics: ≥6 yrs: Individualize dose. Take bid, at least 4 hrs apart. Methylphenidate-Naive: Initial: 5mg/day (2.5mg bid). Titrate: May adjust weekly in 2.5-5mg increments. Max: 20mg/day (10mg bid). Currently on Methylphenidate: Initial: 1/2 of methylphenidate dose. Max: 20mg/day (10mg bid). Reduce or d/c if paradoxical aggravation of symptoms or other adverse events occur. D/C if no improvement seen after appropriate dosage adjustment over 1 month.

HOW SUPPLIED

Tab: 2.5mg, 5mg, 10mg

CONTRAINDICATIONS

Marked anxiety, tension, agitation, glaucoma, motor tics, or family history or diagnosis of Tourette's syndrome. Treatment with MAOI or within 14 days following d/c of MAOI.

WARNINGS/PRECAUTIONS

Avoid with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease (CAD), or other serious cardiac problems. Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial infarction (MI) reported in adults. May cause modest increase in average BP and HR; caution with HTN, heart failure, recent MI, or ventricular arrhythmia. Prior to treatment, perform medical history (including assessment for family history of sudden death or ventricular arrhythmia) and physical exam to assess for presence of cardiac disease. Promptly perform cardiac evaluation if symptoms of cardiac disease develop during treatment. May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder. Caution in patients with comorbid bipolar disorder; may induce mixed/manic episodes. May cause treatment-emergent psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) at usual doses in children and adolescents without prior history of psychotic illness or mania; d/c may be appropriate. Aggressive behavior or hostility reported. May cause long-term suppression of growth in children; monitor height and weight and may need to interrupt treatment in patients not growing or gaining height or weight as expected. May lower convulsive threshold; d/c in the presence of seizures. Difficulties with accommodation and blurring of vision reported. Monitor CBC, differential, and platelet counts during prolonged therapy. Use as part of total treatment program for ADHD that may include other measures (psychological, educational, social). Not for patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders (eg, psychosis).

ADVERSE REACTIONS

Abdominal pain, fever, anorexia, nausea, nervousness, insomnia. (Pediatrics) Loss of appetite, weight loss, tachycardia.

DRUG INTERACTIONS

See Contraindications. May decrease the effectiveness of drugs used to treat HTN. Caution with pressor agents. May inhibit metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone) and some antidepressants (eg, TCAs, SSRIs); downward dose adjustments and monitoring of plasma drug levels (coagulation times for coumarin) of these drugs may be required when initiating or d/c therapy. Possible neuroleptic malignant syndrome-like event may occur with concurrent venlafaxine.

PREGNANCY

Category C, caution in nursing.

MECHANISM OF ACTION

Sympathomimetic amine; CNS stimulant. Mechanism in ADHD has not been established; suspected to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into extraneuronal space.

PHARMACOKINETICS

Absorption: Readily absorbed; Tmax=2.9 hrs (fed), 1-1.5 hrs (fasted). Metabolism: De-esterification; d-ritalinic acid (primary metabolite). Elimination: Urine (90%, racemic methylphenidate); T1/2=2.2 hrs.

ASSESSMENT

Assess for previous hypersensitivity to the drug, history of drug dependence or alcoholism, marked anxiety, agitation, tension, glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, preexisting psychotic disorders, bipolar disorder or risk thereof, history of seizures, pregnancy/nursing status, and for possible drug interactions. Assess for medical conditions that might be compromised by increases in BP and HR, structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac problems. Perform physical exam and obtain medical history.

MONITORING

Monitor BP, HR and for signs/symptoms of cardiac disease (eg, exertional chest pain, unexplained syncope), exacerbation of behavioral disturbance and thought disorder, bipolar disorder, worsening of aggressive behavior or hostility, emergent psychotic/manic symptoms, seizures, and visual disturbances. During prolonged use, periodically evaluate usefulness and monitor CBC, differential, and platelet counts. In pediatric patients, monitor height and weight.

PATIENT COUNSELING

Inform about risks and benefits of treatment. Counsel that drug has potential for abuse or dependence; instruct to keep medication in a safe place to prevent misuse and abuse. Advise to notify physician if new or worsening mental symptoms/problems or other adverse reactions develop.

ADMINISTRATION/STORAGE

Administration: Oral route. Take with or without food. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light and moisture.


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    Focalin

    Focalin

    Pronunciation Generic Name: dexmethylphenidate (Oral route)

    dex-meth-il-FEN-i-date

    OverviewSide EffectsInteractionsFor ProfessionalsMore… Oral route(Capsule, Extended Release;Tablet) Give cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur .

    Commonly used brand name(s)

    In the U.S.

    • Focalin
    • Focalin XR

    Available Dosage Forms:

    • Tablet
    • Capsule, Extended Release

    Therapeutic Class: CNS Stimulant

    Chemical Class: Amphetamine Related

    Uses For Focalin

    Dexmethylphenidate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.

    Dexmethylphenidate increases attention and decreases restlessness in children and adults who are hyperactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

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

    Before Using Focalin

    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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dexmethylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

    Geriatric

    Appropriate studies on the relationship of age to the effects of dexmethylphenidate have not been performed in the geriatric population.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

    • Brofaromine
    • Clorgyline
    • Furazolidone
    • Iproniazid
    • Isocarboxazid
    • Lazabemide
    • Linezolid
    • Moclobemide
    • Nialamide
    • Pargyline
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Selegiline
    • Toloxatone
    • Tranylcypromine

    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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    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:

    • Agitation, severe or
    • Anxiety, severe or
    • Glaucoma or
    • Motor tics (repeated muscle movements), history of or
    • Tension, severe or
    • Tourette’s syndrome, or family history of—Should not be used in patients with these conditions.
    • Alcohol abuse, history of or
    • Drug abuse and dependence, history of—Dependence may be more likely to develop.
    • Bipolar disorder (manic-depressive illness), history of or
    • Blood vessel problems or
    • Coronary artery disease or
    • Depression, or a family history of or
    • Heart attack, recent or
    • Heart disease (e.g., cardiomyopathy) or
    • Heart failure or
    • Heart rhythm problems (e.g., ventricular arrhythmia), or a family history of or
    • Hypertension (high blood pressure) or
    • Psychosis (mental illness), history of or
    • Seizures, history of or
    • Stroke, history of or
    • Tachycardia (increased heart rate)—Use with caution. May make these conditions worse.

    Proper Use of dexmethylphenidate

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

    Take this medicine only as directed by your doctor. 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. If too much is taken, it may be habit-forming. If you or your child feel that the medicine is not working properly after you have taken it for several weeks, check with your doctor.

    This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

    This medicine may be taken with or without food.

    You should take the extended-release capsule only once a day and in the morning. If you take this medicine in the afternoon or evening, it might be harder for you to fall asleep. If your doctor tells you to take the medicine at a certain time, take it exactly as directed.

    Swallow the extended-release capsule whole. Do not crush, divide, or chew it.

    If you or your child are unable to swallow the capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The medicine and applesauce can not be stored for future use.

    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 attention deficit hyperactivity disorder (ADHD):
      • For oral dosage form (extended-release capsules):
        • Adults:
          • Patients new to dexmethylphenidate—At first, 10 milligrams (mg) once a day in the morning. If needed, your doctor may increase your dose once a week by 10 mg per day until symptoms improve or a maximum dose of 40 mg per day is reached.
          • Patients currently taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, given once a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 40 mg per day.
          • Patients using the regular dexmethylphenidate tablets will use the same number of milligrams per day as a single dose for the extended-release capsules.
        • Children 6 years of age and older:
          • Patients new to dexmethylphenidate—At first, 5 milligrams (mg) once a day in the morning. If needed, your doctor may increase your dose once a week by 5 mg per day until symptoms improve or a maximum dose of 30 mg per day is reached.
          • Patients currently taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, given once a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 30 mg per day.
          • Patients using the regular dexmethylphenidate tablets will use the same number of milligrams per day as a single dose for the extended-release capsules.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • For oral dosage form (tablets):
        • Adults, teenagers, and children 6 years of age and older:
          • Patients new to methylphenidate—At first, 2.5 milligrams (mg) two times a day, at least 4 hours apart. If needed, your doctor may increase your dose once a week by 2.5 or 5 mg per day until symptoms improve or a maximum dose of 10 mg two times a day is reached.
          • Patients currently taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, divided and taken two times a day at least 4 hours apart. If needed, your doctor will adjust your dose once a week to a maximum dose of 10 mg two times a day.
        • Children younger than 6 years of age—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 Focalin

    It is very important that your doctor check your or your child’s progress at regular visits to make sure the dose is right and the medicine is helping you. Your doctor might need to check your blood, heart, and blood pressure for any unwanted effects.

    You or your child should not use this medicine if you have used a medicine for depression called a monoamine oxidase inhibitor (MAOI) in the past 14 days. Some examples of MAOI are isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®, Zelapar®), or tranylcypromine (Parnate®).

    Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

    This medicine may cause some people to have vision changes or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.

    Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, shortness of breath, or fainting while taking this medicine.

    Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

    This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child’s height and weight to make sure that your child is growing properly.

    Focalin 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:

    Less common

    • Fast, pounding, or irregular heartbeat or pulse

    Rare

    • Blurred vision
    • change in near or distance vision
    • difficulty in focusing the eyes

    Incidence not known

    • Convulsions
    • muscle spasm or jerking of the arms and legs
    • sudden loss of consciousness

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

    Symptoms of overdose

    • Anxiety
    • bigger, dilated, or enlarged pupils (black part of the eye)
    • blurred vision
    • change in consciousness
    • chest pain or discomfort
    • confusion as to time, place, or person
    • dizziness
    • dry mouth
    • fainting
    • fast, slow, or irregular heartbeat
    • feeling of warmth
    • fever
    • hallucinations
    • headache
    • hyperventilation
    • increased sensitivity of the eyes to light
    • irritability
    • lightheadedness
    • loss of consciousness
    • mood or mental changes
    • muscle twitching
    • nervousness
    • overactive reflexes
    • pounding in the ears
    • pounding or rapid pulse
    • redness of the face, neck, arms, and occasionally, upper chest
    • restlessness
    • seeing, hearing, or feeling things that are not there
    • seizures
    • shaking
    • shortness of breath
    • sweating
    • tremors or shakiness
    • trouble sleeping
    • unusual excitement
    • vomiting

    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:

    More common

    • Acid or sour stomach
    • belching
    • heartburn
    • indigestion
    • loss of appetite
    • nausea
    • stomach discomfort, upset, or pain
    • throat pain
    • weight loss

    Less common

    • Sleeplessness
    • twitching
    • unable to sleep

    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: Focalin side effects (in more detail)

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    Focalin

    Focalin

    Pronunciation Generic Name: Dexmethylphenidate Hydrochloride
    Class: Respiratory and CNS Stimulants

    VA Class: CN802

    For ProfessionalsSide EffectsInteractionsMore…

    Introduction

    Stimulant; the more pharmacologically active (d-threo) enantiomer of racemic methylphenidate; pharmacologic actions qualitatively similar to those of amphetamines.1 4

    Uses for Focalin

    Attention Deficit Hyperactivity Disorder (ADHD)

    Treatment of ADHD, alone or combined with behavioral treatment, as an adjunct to psychological, educational, social, and other remedial measures in carefully selected children ≥6 years of age, adolescents, and adults.1 4

    Focalin Dosage and Administration

    General

    • Carefully adjust dosage according to individual requirements and response.1 4

    • For patients whose symptoms are not severe outside school, may attempt drug holidays for all or part of the summer to assess continuing efficacy and need for therapy, as well as to minimize adverse effects.5
    • Discontinue therapy if a beneficial effect is not attained after appropriate dosage adjustment over 1 month.1 4
    • If paradoxical aggravation of symptoms occurs, reduce dosage or discontinue the drug.1 4
    • Periodically discontinue therapy to assess the patient’s condition; improvement may be maintained temporarily or permanently after the drug is discontinued.1 4

    Administration

    Oral Administration

    Conventional Tablets

    Administer orally twice daily without regard to meals; administer doses at least 4 hours apart.1

    Extended-release Capsules

    Administer orally once daily in the morning with or without food.4 6

    Swallow capsules intact.4 6 Do not crush, chew, or subdivide the capsule contents.4 6

    Alternatively, open capsule(s) and sprinkle entire contents on a small amount (e.g., 1 spoonful) of applesauce immediately prior to administration.4 6 Do not store the sprinkle/applesauce mixture for later use.4 6

    Dosage

    Available as dexmethylphenidate hydrochloride; dosage expressed in terms of the salt.1

    Pediatric Patients

    ADHD
    Conventional Tablets

    Oral Children ≥6 years of age: Initially, 2.5 mg twice daily for children who currently are not receiving racemic methylphenidate or are receiving stimulants other than methylphenidate.1 Increase dosage by 2.5–5 mg daily at weekly intervals (up to maximum dosage of 20 mg daily).1

    Children ≥6 years of age: Initially administer one-half the current methylphenidate hydrochloride dosage in children who are being transferred from racemic methylphenidate to dexmethylphenidate therapy.1

    Extended-release Capsules

    Oral Children ≥6 years of age: Initially, 5 mg once daily for children who currently are not receiving dexmethylphenidate or racemic methylphenidate or who are receiving stimulants other than methylphenidate.4 Increase dosage by 5 mg daily at weekly intervals (up to maximum dosage of 20 mg daily).4

    Children ≥6 years of age: Substitute extended-release capsules for conventional tablets at same total daily dosage.4

    Children ≥6 years of age: Initially administer one-half the current methylphenidate hydrochloride dosage in children who are being transferred from racemic methylphenidate to dexmethylphenidate therapy.4

    Adults

    ADHD
    Extended-release Capsules

    Oral Initially, 10 mg once daily for patients who currently are not receiving dexmethylphenidate or racemic methylphenidate or who are receiving stimulants other than methylphenidate.4 Increase dosage by 10 mg daily after 1 week (up to maximum dosage of 20 mg daily).4

    Substitute extended-release capsules for conventional tablets at same total daily dosage.4

    Initially administer one-half the current methylphenidate hydrochloride dosage in patients who are being transferred from racemic methylphenidate to dexmethylphenidate therapy.4

    Prescribing Limits

    Pediatric Patients

    ADHD
    Oral

    Maximum 20 mg daily.1 4

    Long-term use (>6 weeks for conventional tablets or >7 weeks for extended-release capsules) has not been studied systematically.1 4 If used for long-term therapy, periodically reevaluate the usefulness of the drug.1 4

    Adults

    ADHD
    Oral

    Maximum 20 mg daily.1 4

    Long-term use (>6 weeks for conventional tablets or >7 weeks for extended-release capsules) has not been studied systematically.1 4 If used for long-term therapy, periodically reevaluate the usefulness of the drug.1 4

    Special Populations

    Hepatic Impairment

    No specific dosage recommendations.1 4 (See Hepatic Impairment under Cautions.)

    Renal Impairment

    No specific dosage recommendations.1 4 (See Renal Impairment under Cautions.)

    Cautions for Focalin

    Contraindications

    • Marked anxiety, tension, and agitation.1 4

    • Glaucoma.1 4
    • Motor tics or a family history or a diagnosis of Tourette’s syndrome.1 3 4 However, the AAP states that the presence of tics before or during medical management of ADHD is not an absolute contraindication to stimulant drug use.3
    • Concomitant or recent (within 14 days) administration of MAO inhibitors.1 4 (See MAO Inhibitors under Interactions.)
    • Known hypersensitivity to dexmethylphenidate, methylphenidate, or any ingredient in the formulation.1 4

    Warnings/Precautions

    Warnings

    Dexmethylphenidate shares the toxic potentials of racemic methylphenidate; observe the usual precautions of racemic methylphenidate therapy.1 4

    Abuse Potential

    Tolerance and psychological dependence may occur with chronic abuse.1 4

    Psychotic episodes can occur, particularly with parenteral abuse.1 4

    Use with caution in patients with a history of drug or alcohol dependence.1 4 5 Caution may be indicated in patients with comorbid conduct disorder or a chaotic family.5 If the risk of drug abuse by the patient or the patient’s peers or family is considered high, a nonstimulant drug may be preferable.5

    Withdrawal Effects

    Abrupt withdrawal of therapy following prolonged administration may unmask severe depression.1 4 Long-term follow-up may be required.1 4

    Sudden Death and Serious Cardiovascular Events

    Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.1 4

    Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.8 9 10 FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.8 FDA is conducting an ongoing safety review of amphetamines and other stimulants to evaluate possible link between use of these agents and sudden death in children.8 9 10 Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.8

    Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).1 4

    In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.1 4

    Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.1 4

    Effects on BP and Heart Rate

    Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.1 4 Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.1 4

    Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).1 4

    Exacerbation or Precipitation of Psychotic Symptoms

    May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.1 4

    Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.1 4 If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 4

    Precipitation of Manic Symptoms

    May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.1 4 Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).1 4

    Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.1 4 If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 4

    Aggression

    Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.1 4 No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.1 4

    Growth Suppression

    Long-term (i.e., >14 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 4

    Manufacturer recommends monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.1 4 However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.3

    Seizures

    Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.1 4 If seizures occur, discontinue therapy.1 4

    Visual Disturbances

    Visual disturbances (difficulty with accommodation, blurred vision) reported with stimulants.1 4

    General Precautions

    Hematologic Monitoring

    Manufacturer recommends periodic monitoring of CBC (with differential) and platelet counts during prolonged therapy;1 4 however, AAP and many clinicians consider routine hematologic monitoring unnecessary in patients receiving recommended stimulants (e.g., methylphenidate, amphetamines) in the absence of clinical signs (e.g., fever, sore throat, unusual bleeding or bruising) suggestive of hematologic toxicity.3

    Specific Populations

    Pregnancy

    Category C.1 4

    Lactation

    Not known whether dexmethylphenidate is distributed into milk; caution advised if used in nursing women.1 4

    Pediatric Use

    Safety and efficacy not established in children <6 years of age.1 4

    Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.1 4 (See Warnings under Cautions.)

    Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.1 4 Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.8 9 10 (See Sudden Death and Serious Cardiovascular Events under Cautions.)

    Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 4 (See Growth Suppression under Cautions.)

    Hepatic Impairment

    Safety and efficacy not established.1 4

    Renal Impairment

    Safety and efficacy not established.1 4

    Common Adverse Effects

    Conventional tablets: Abdominal pain, fever, anorexia, nausea.1

    Extended-release capsules: Decreased appetite, headache, dyspepsia, dry mouth, anxiety, pharyngolaryngeal pain.4

    Interactions for Focalin

    Does not inhibit CYP isoenzymes in vitro.1 4

    MAO Inhibitors

    Pharmacologic interaction (potentiation of pressor effects, possible hypertensive crisis); dexmethylphenidate is contraindicated in patients currently or recently (i.e., within 14 days) receiving MAO inhibitors.1 4

    Pressor Agents

    Possible pharmacologic interaction (increased hypertensive effects); use with caution.1 4

    Drugs Affecting GI pH

    Studies to evaluate the effects of changes in gastric pH on absorption of dexmethylphenidate hydrochloride extended-release capsules have not been performed.4 However, potential exists for pharmacokinetic interaction (altered release of dexmethylphenidate hydrochloride) between Focalin XR extended-release capsules and drugs that alter gastric pH (e.g., antacids, acid suppressants).4

    Interactions Involving Methylphenidate

    The possibility that drug interactions reported with racemic methylphenidate also could occur with dexmethylphenidate should be considered.1 4

    Drug

    Interaction with Methylphenidate

    Comments

    Anticonvulsants (e.g., phenobarbital, phenytoin, primidone)

    Possible inhibition of anticonvulsant metabolism1 4

    Monitor plasma anticonvulsant concentrations when initiating or discontinuing methylphenidate; reduction of anticonvulsant dosage may be required during concomitant therapy1 4

    Clonidine

    Serious adverse effects reported; causality not established1 4

    Coumarin anticoagulants (e.g., warfarin)

    Possible inhibition of anticoagulant metabolism1 4

    Monitor PT when initiating or discontinuing methylphenidate; reduction of anticoagulant dosage may be required during concomitant therapy1 4

    Hypotensive agents

    Antagonism of hypotensive effect1 4

    Serotonin-reuptake inhibitors

    Possible inhibition of antidepressant metabolism1

    Reduction of antidepressant dosage may be required during concomitant therapy1

    Tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)

    Possible inhibition of antidepressant metabolism1 4

    Reduction of antidepressant dosage may be required during concomitant therapy1 4

    Focalin Pharmacokinetics

    Absorption

    Bioavailability

    Readily absorbed following oral administration.1 Mean absolute bioavailability is 22–25% due to high first-pass metabolism.4

    Peak plasma concentrations for conventional tablets are achieved within 60–90 minutes following oral administration in fasting patients.1

    Peak plasma concentrations for extended-release capsules (Focalin XR) are attained at 1.5 hours and again at 6.5 hours after a dose.4

    Extended-release capsules are absorbed more slowly but to the same extent as conventional tablets.4 AUC is similar for extended-release capsules (administered once daily) and conventional tablets (same daily dosage administered in 2 divided doses 4 hours apart).4

    Comparable plasma concentrations achieved following single-dose administration of dexmethylphenidate hydrochloride capsules or single-dose administration of racemic methylphenidate hydrochloride capsules at equimolar doses (twice the total mg amount of dexmethylphenidate hydrochloride).1

    Food

    Conventional tablets: High-fat meal slows rate of absorption but does not alter peak concentration or extent of absorption compared with administration in fasting state.1

    Extended-release capsules: Effects of food on absorption characteristics not studied but thought to be similar to those observed with similar extended-release formulation of racemic methylphenidate.4 Administration of extended-release racemic methylphenidate formulation with high-fat meal results in delayed absorption during first and second absorption phases and lower peak concentration during second absorption phase; extent of absorption not affected.4 Plasma concentration-time profile is similar following administration of extended-release racemic methylphenidate formulation with applesauce compared with administration under fasting conditions.4

    Special Populations

    Following administration of conventional tablets, AUC is higher in women than in men; pharmacokinetics parameters are similar between boys and girls.1 Following administration of extended-release capsules, peak plasma concentration during first absorption phase is higher in women than in men.4

    Following administration of conventional tablets, AUC is lower in children than in adults.1 Pharmacokinetics of extended-release capsules not studied in children; however, following administration of a similar formulation of racemic methylphenidate, between-peak minimum and second peak concentrations were delayed and more variable in children than in adults.4

    Distribution

    Extent

    Not known whether dexmethylphenidate crosses placenta or distributes into milk.1

    Elimination

    Metabolism

    Metabolized principally by de-esterification to form d-ritalinic acid, which has little or no pharmacologic activity.1 4

    Elimination Route

    Excreted in urine, principally as ritalinic acid.1 4

    Half-life

    2–3 hours in children or 2–4.5 hours in adults.1 4

    Stability

    Storage

    Oral

    Conventional Tablets

    25°C (may be exposed to 15–30°C).1 Protect from light and moisture.1

    Extended-release Capsules

    Tight container at 25°C (may be exposed to 15–30°C).4

    Actions

    • Appears to block norepinephrine and dopamine reuptake into the presynaptic neuron and increases their release into the extraneuronal space.1 4 Mechanism of action for treatment of ADHD not determined.1 4

    Advice to Patients

    • Provide patient or caregiver with a copy of manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.1 4 Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.1 4 6 7

    • Importance of informing clinicians immediately of any adverse cardiovascular (e.g., chest pain, shortness of breath, fainting) or psychiatric effects (e.g., hallucinations, delusional thinking, mania).6 7
    • Importance of taking the drug exactly as prescribed.6 7
    • Importance of not chewing or crushing the beads contained in the capsules and of not storing the sprinkle/food mixture for later use.4 6
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, as well as any concomitant illnesses/conditions (e.g., glaucoma, cardiac/cardiovascular disease, mental/psychiatric disorder, seizures, suicidal ideation or behaviors, history of substance abuse).1 4 6 7
    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 4 6 7
    • Importance of informing patients of other important precautionary information.1 4 6 7 (See Cautions.)

    Preparations

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

    Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.1 4

    Dexmethylphenidate Hydrochloride
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    Capsules, extended-release (containing beads)

    5 mg (beads, delayed-release, enteric-coated extended-release 2.5 mg with immediate-release 2.5 mg)

    Focalin XR ( C-II)

    Novartis

    10 mg (beads, delayed-release, enteric-coated extended-release 5 mg with immediate-release 5 mg)

    Focalin XR ( C-II)

    Novartis

    15 mg (beads, delayed-release, enteric-coated extended-release 7.5 mg with immediate-release 7.5 mg)

    Focalin XR ( C-II)

    Novartis

    20 mg (beads, delayed-release, enteric-coated extended-release 10 mg with immediate-release 10 mg)

    Focalin XR ( C-II)

    Novartis

    Tablets

    2.5 mg

    Focalin ( C-II)

    Novartis

    5 mg

    Focalin ( C-II)

    Novartis

    10 mg

    Focalin ( C-II; dye-free)

    Novartis

    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.

    Dexmethylphenidate HCl 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$43.99 or 90/$119.96

    Dexmethylphenidate HCl 2.5MG Tablets (TEVA PHARMACEUTICALS USA): 20/$21.99 or 30/$31.48

    Focalin 10MG Tablets (NOVARTIS): 20/$36.97 or 30/$55.46

    Focalin 5MG Tablets (NOVARTIS): 20/$28.88 or 30/$43.32

    Focalin XR 10MG 24-hr Capsules (NOVARTIS): 20/$121.99 or 30/$181.97

    Focalin XR 15MG 24-hr Capsules (NOVARTIS): 20/$121.99 or 30/$182.97

    Focalin XR 30MG 24-hr Capsules (NOVARTIS): 20/$126.99 or 30/$187.97

    Focalin XR 40MG 24-hr Capsules (NOVARTIS): 30/$199.99 or 90/$575.97

    Focalin XR 5MG 24-hr Capsules (NOVARTIS): 20/$116.99 or 30/$173.22

    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 November 20, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    References

    1. Novartis. Focalin (dexmethylphenidate hydrochloride) tablets prescribing information. East Hanover, NJ; 2007 Apr.

    2. FDA approval package, Medical review (part 2). Rockville, MD; 2001. From the FDA website.

    3. American Academy of Pediatrics Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical treatment guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001; 108:1033-44. [IDIS 470916] [PubMed 11581465]

    4. Novartis. Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules prescribing information. East Hanover, NJ; 2007 Apr.

    5. American Academy of Child and Adolescent Psychiatry. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997; 36(Suppl):85-121S. [PubMed 9000785]

    6. Novartis. Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules medication guide. East Hanover, NJ; 2007 Apr.

    7. Novartis. Focalin (dexmethylphenidate hydrochloride) tablets medication guide. East Hanover, NJ; 2007 Apr.

    8. Food and Drug Administration. FDA Alert: Information for healthcare professionals: Communication about an ongoing safety review of stimulant medications [dexmethylphenidate (marketed as Focalin, Focalin XR), dextroamphetamine (marketed as Dexedrine, Dexedrine Spansules, Dextrostat, and generics), lisdexamfetamine (marketed as Vyvanse), methamphetamine (marketed as Desoxyn), methylphenidate (marketed as Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, and Ritalin-SR), mixed salts amphetamine (marketed as Adderall and Adderall XR), and pemoline (marketed as Cylert and generics)] used in children with attention-deficit/hyperactivity disorder (ADHD). Rockville, MD; 2009 Jun 23. From the FDA website.

    9. Gould MS, Walsh BT, Munfakh JL et al. Sudden death and use of stimulant medications in youths. Am J Psychiatry. 2009; 166:992-1001. [PubMed 19528194]

    10. Vitiello B, Towbin K. Stimulant treatment of ADHD and risk of sudden death in children. Am J Psychiatry. 2009; 166:955-7. [PubMed 19528196]

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    Focalin

    Focalin

    Pronunciation Generic Name: dexmethylphenidate (dex-METH-il-FEN-i-date)

    Brand Name: Focalin

    Use Focalin with caution if you have a history of mental or mood problems, or alcohol or substance abuse or dependence. Abuse of Focalin may cause it to not work as well. Abuse may also lead to addiction and mental or mood changes. Do not suddenly stop using Focalin. Depression or other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    Focalin is used for:

    Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

    Focalin is a central nervous system stimulant. Exactly how it works is not known.

    Do NOT use Focalin if:

    • you are allergic to any ingredient in Focalin or to methylphenidate
    • you have severe anxiety, agitation, or tension
    • you have glaucoma
    • you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
    • you have serious heart problems (eg, heart defect, irregular heartbeat)
    • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

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

    Before using Focalin:

    Some medical conditions may interact with Focalin. 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 have a history of high blood pressure, heart problems (eg, heart failure, heart defects, fast or irregular heartbeat), blood vessel problems, or heart attack, or if a family member has a history of any of these problems or sudden death
    • if you have a history of seizures or abnormal electroencephalograms (EEGs)
    • if you have a history of an overactive thyroid or chronic fatigue
    • if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

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

    • MAOIs (eg, phenelzine) because severe high blood pressure may occur
    • Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Focalin
    • Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by Focalin

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Focalin 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 Focalin:

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

    • Focalin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Focalin refilled.
    • Take Focalin by mouth with or without food.
    • Take your doses at least 4 hours apart unless your doctor tells you otherwise.
    • You may have trouble sleeping while taking Focalin. If this occurs, taking your last dose earlier in the day may help. Check with your doctor before you change the way that you take Focalin. If trouble sleeping continues, talk with your doctor.
    • If you miss a dose of Focalin, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

    Important safety information:

    • Focalin may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Focalin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Do NOT take more than the recommended dose without checking with your doctor.
    • Focalin should be used as part of an ADHD treatment program that includes a variety of treatment measures (eg, psychological, educational, social).
    • If your condition does not get better within 1 month or if it gets worse, check with your doctor.
    • Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or another serious problem, talk with your doctor about other therapies to treat your condition.
    • Tell your doctor or dentist that you take Focalin before you receive any medical or dental care, emergency care, or surgery.
    • Before you start any new medicine, check the label to see if it has a decongestant in it. If it does or if you are not sure, check with your doctor or pharmacist.
    • Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Focalin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • Focalin may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Focalin.
    • Caution is advised when using Focalin in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
    • Focalin should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Focalin while you are pregnant. It is not known if Focalin is found in breast milk. If you are or will be breast-feeding while you use Focalin, check with your doctor. Discuss any possible risks to your baby.

    When used for long periods of time or at high doses, Focalin may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Focalin stops working well. Do not take more than prescribed.

    Some people who use Focalin for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Focalin. If you stop taking Focalin suddenly, you may have WITHDRAWAL symptoms. These may include depression or other mental problems.

    Possible side effects of Focalin:

    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; headache; indigestion; loss of appetite; nausea; nervousness; stomach pain; stuffy nose; trouble sleeping; vomiting; weight loss.

    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, throat, or tongue; joint pain; purple or brownish red spots on the skin; unusual hoarseness); blurred vision or other vision problems; chest, jaw, or arm pain; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; new or worsening mental, mood, or behavior changes (eg, abnormal thoughts, aggression, agitation, anxiety, depression, hostility, irritability, panic attacks, persistent crying, restlessness, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; sudden, severe nausea or vomiting; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; unusual sweating; unusual tiredness or weakness; yellowing of the eyes or skin.

    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 confusion; dilated pupils; exaggerated reflexes; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; mental or mood changes (eg, agitation); muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.

    Proper storage of Focalin: Store Focalin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Focalin out of the reach of children and away from pets.

    General information:

    • If you have any questions about Focalin, please talk with your doctor, pharmacist, or other health care provider.
    • Focalin 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 Focalin 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 Focalin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Focalin. 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 Focalin.

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

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    Focalin

    Focalin

    Pronunciation Generic Name: dexmethylphenidate hydrochloride

    Dosage Form: tablet

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Focalin®

    Rx only

    Prescribing Information

    DESCRIPTION

    Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in three tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its empirical formula is C14H19NO2•HCl. Its molecular weight is 269.77 and its structural formula is

    Note: * = asymmetric carbon centers

    Dexmethylphenidate hydrochloride is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.

    Focalin also contains the following inert ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.

    CLINICAL PHARMACOLOGY

    Pharmacodynamics

    Dexmethylphenidate hydrochloride is a central nervous system stimulant. Focalin, the more pharmacologically active enantiomer of the d- and l-enantiomers, is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known.

    Effects on QT Interval

    The effect of Focalin® XR on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Focalin® XR 40mg in 75 healthy volunteers. ECGs were collected up to 12 h post-dose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was <5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.

    Pharmacokinetics

    Absorption Dexmethylphenidate hydrochloride is readily absorbed following oral administration of Focalin. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1½ hours post-dose. No differences in the pharmacokinetics of Focalin were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD.

    When given to children as capsules in single doses of 2.5 mg, 5 mg, and 10 mg, Cmax and AUC0-inf of dexmethylphenidate were proportional to dose. In the same study, plasma dexmethylphenidate levels were comparable to those achieved following single dl-threo-methylphenidate HCl doses given as capsules in twice the total mg amount (equimolar with respect to Focalin).

    Food Effects In a single dose study conducted in adults, coadministration of 2 x 10 mg Focalin with a high fat breakfast resulted in a dexmethylphenidate tmax of 2.9 hours post-dose as compared to 1.5 hours post-dose when given in a fasting state. Cmax and AUC0-inf were comparable in both the fasted and non-fasted states.

    Distribution Plasma dexmethylphenidate concentrations in children decline exponentially following oral administration of Focalin.

    Metabolism and Excretion In humans, dexmethylphenidate is metabolized primarily to d-α-phenyl-piperidine acetic acid (also known as d-ritalinic acid) by de-esterification. This metabolite has little or no pharmacological activity. There is little or no in vivo interconversion to the l-threo-enantiomer, based on a finding of minute levels of l-threo-methylphenidate being detectable in a few samples in only 2 of 58 children and adults. After oral dosing of radiolabeled racemic methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was ritalinic acid, accountable for approximately 80% of the dose.

    In vitro studies showed that dexmethylphenidate did not inhibit cytochrome P450 isoenzymes.

    The mean plasma elimination half-life of dexmethylphenidate is approximately 2.2 hours.

    Special Populations

    Gender Pharmacokinetic parameters were similar for boys and girls (mean age 10 years).

    In a single dose study conducted in adults, the mean dexmethylphenidate AUC0-inf values (adjusted for body weight) following single 2 x 10 mg doses of Focalin were 25%-35% higher in adult female volunteers (n=6) compared to male volunteers (n=9). Both tmax and t1/2 were comparable for males and females.

    Race There is insufficient experience with the use of Focalin to detect ethnic variations in pharmacokinetics.

    Age The pharmacokinetics of dexmethylphenidate after Focalin administration have not been studied in children less than 6 years of age. When single doses of Focalin were given to children between the ages of 6 to 12 years and healthy adult volunteers, Cmax of dexmethylphenidate was similar, however, children showed somewhat lower AUCs compared to the adults.

    Renal Insufficiency There is no experience with the use of Focalin in patients with renal insufficiency. After oral administration of radiolabeled racemic methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid. Since very little unchanged drug is excreted in the urine, renal insufficiency is expected to have little effect on the pharmacokinetics of Focalin.

    Hepatic Insufficiency There is no experience with the use of Focalin in patients with hepatic insufficiency. (For Drug Interactions, see PRECAUTIONS.)

    Clinical Studies

    Focalin was evaluated in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients aged 6 to 17 years old with a DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). Both studies included all three subtypes of ADHD, i.e., Combined Type, Predominantly Inattentive Type, or Predominantly Hyperactive-Impulsive Type. While both children and adolescents were included, the sample was predominantly children, thus, the findings are most pertinent to this age group. In both studies, the primary comparison of interest was Focalin versus placebo.

    Focalin (5, 10, or 20 mg/day total dose), dl-threo-methylphenidate HCl (10, 20, or 40 mg/day total dose), and placebo were compared in a multicenter, 4-week, parallel group study in n=132 patients. Patients took the study medication twice daily, 3.5 to 5.5 hours between doses. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose. The change from baseline to week 4 of the averaged score (an average of two ratings during the week) of the teacher’s version of the SNAP-ADHD Rating Scale, a scale for assessing ADHD symptoms, was the primary outcome. Patients treated with Focalin showed a statistically significant improvement in symptom scores from baseline over patients who received placebo.

    Figure 1  Mean Change from Baseline in Teacher SNAP-ADHD Scores in a 4-week Double-Blind Placebo-Controlled Study of Focalin®*

    *Figure 1: Error bars represent the standard error of the mean.

    The other study, involving n=75 patients, was a multicenter, placebo-controlled, double-blind, 2-week treatment withdrawal study in children who were responders during a 6-week, open label initial treatment period. Children took study medication twice a day separated by a 3.5 to 5.5 hour interval. The primary outcome was proportion of treatment failures at the end of the 2-week withdrawal phase, where treatment failure was defined as a rating of 6 (much worse) or 7 (very much worse) on the Investigator Clinical Global Impression – Improvement (CGI-I). Patients continued on Focalin showed a statistically significant lower rate of failure over patients who received placebo.

    Figure 2  Percent of Treatment Failures following a 2-week Double-Blind Placebo-Controlled Withdrawal of Focalin®

    INDICATION AND USAGE

    Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

    The efficacy of Focalin in the treatment of ADHD was established in two controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD (see Clinical Studies).

    A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning; and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go,” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

    Special Diagnostic Considerations

    Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.

    Need for Comprehensive Treatment Program

    Focalin is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.

    Long-term Use

    The effectiveness of Focalin for long-term use, i.e., for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Focalin for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

    CONTRAINDICATIONS

    Agitation

    Focalin is contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.

    Hypersensitivity to Methylphenidate

    Focalin is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. Hypersensitivity reactions, including angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate [see Adverse Reactions].

    Glaucoma

    Focalin is contraindicated in patients with glaucoma.

    Tics

    Focalin is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome (see ADVERSE REACTIONS).

    Monoamine Oxidase Inhibitors

    Focalin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

    WARNINGS

    Serious Cardiovascular Events

    Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems

    Children and Adolescents

    Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

    Adults

    Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

    Hypertension and Other Cardiovascular Conditions Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

    Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

    Psychiatric Adverse Events

    Pre-Existing Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

    Bipolar Illness Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid 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.

    Emergence of New Psychotic or Manic Symptoms Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

    Aggression Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

    Long-Term Suppression of Growth

    Careful follow- up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

    Seizures

    There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

    Visual Disturbance

    Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

    Use in Children Under 6 Years of Age

    Focalin should not be used in children under 6 years, since safety and efficacy in this age group have not been established.

    DRUG DEPENDENCE: Focalin should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

    PRECAUTIONS

    Hematologic Monitoring

    Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

    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 dexmethylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Focalin. 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.

    Drug Interactions

    Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Because of possible effects on blood pressure, Focalin should be used cautiously with pressor agents.

    Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

    Carcinogenesis, Mutagenesis, and Impairment of Fertility

    Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

    Racemic methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.

    In a 24-week study of racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60-74 mg/kg/day of racemic methylphenidate.

    Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, the in vitro mouse lymphoma cell forward mutation assay, or the in vivo mouse bone marrow micronucleus test.

    Racemic methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or the in vitro mouse lymphoma cell forward mutation assay, and was negative in vivo in the mouse bone marrow micronucleus assay. However, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay of racemic methylphenidate in cultured Chinese Hamster Ovary (CHO) cells.

    Racemic methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses of up to 160 mg/kg/day.

    Pregnancy

    Pregnancy Category C In studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels (AUCs) of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the maximum recommended human dose of 20 mg/day.

    Racemic methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.

    Adequate and well-controlled studies in pregnant women have not been conducted. Focalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mothers

    It is not known whether dexmethylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Focalin is administered to a nursing woman.

    Pediatric Use

    The safety and efficacy of Focalin in children under 6 years old have not been established.Long-term effects of Focalin in children have not been well established (see WARNINGS).

    In a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of racemic methylphenidate on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the racemic MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the racemic MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

    ADVERSE REACTIONS

    The pre-marketing development program for Focalin included exposures in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects). These participants received Focalin 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in two controlled clinical studies, two clinical pharmacology studies, and two uncontrolled long-term safety studies. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, and results of physical examinations, vital sign and body weight measurements, and laboratory analyses.

    Adverse events during exposure were primarily obtained by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used to classify reported adverse events.

    The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

    Adverse Findings in Clinical Trials with Focalin

    Adverse Events Associated with Discontinuation of Treatment No Focalin-treated patients discontinued due to adverse events in two placebo-controlled trials. Overall, 50 of 684 children treated with Focalin (7.3%) experienced an adverse event that resulted in discontinuation. The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each).

    Adverse Events Occurring at an Incidence of 5% or More Among Focalin-Treated Patients Table 1 enumerates treatment-emergent adverse events for two, placebo-controlled, parallel group trials in children with ADHD at Focalin doses of 5, 10, and 20 mg/day. The table includes only those events that occurred in 5% or more of patients treated with Focalin where the incidence in patients treated with Focalin was at least twice the incidence in placebo-treated patients. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

    Table 1  Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment in Clinical Trials of Focalin®
    Body System Preferred Term Focalin

    (n=79)

    Placebo

    (n=82)

    Body as a Whole
    Abdominal Pain 15% 6%
    Fever 5% 1%
    Digestive System
    Anorexia 6% 1%
    Nausea 9% 1%

    1 Events, regardless of causality, for which the incidence for patients treated with Focalin was at least 5% and twice the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number.

    Adverse Events from Post-Marketing Experience

    The following additional adverse reactions have been identified during postapproval use of Focalin XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

    Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

    Adverse Events with Other Methylphenidate HCl Products

    Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

    Other reactions include:

    Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia

    Gastrointestinal: nausea

    Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

    Nervous System: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette’s syndrome, toxic psychosis

    Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion

    Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

    Blood/lymphatic: leukopenia and/or anemia

    Hepatobiliary: abnormal liver function, ranging from transaminase elevation to hepatic coma

    Psychiatric: transient depressed mood, aggressive behavior

    Skin/subcutaneous: scalp hair loss

    Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

    In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

    DRUG ABUSE AND DEPENDENCE

    Controlled Substance Class

    Focalin, like other methylphenidate products, is classified as a Schedule II controlled substance by Federal regulation.

    Abuse, Dependence, and Tolerance

    See WARNINGS for boxed warning containing drug abuse and dependence information.

    OVERDOSAGE

    Signs and Symptoms

    Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.

    Recommended Treatment

    Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

    Efficacy of peritoneal dialysis for Focalin overdosage has not been established.

    Poison Control Center

    As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

    DOSAGE AND ADMINISTRATION

    Focalin is administered twice daily, at least 4 hours apart. Focalin may be administered with or without food.

    Dosage should be individualized according to the needs and responses of the patient.

    Patients New to Methylphenidate

    The recommended starting dose of Focalin for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).

    Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.

    Patients Currently Using Methylphenidate

    For patients currently using methylphenidate, the recommended starting dose of Focalin is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).

    Maintenance/Extended Treatment

    There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Focalin. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Focalin for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

    Dose Reduction and Discontinuation

    If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

    If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.

    HOW SUPPLIED

    Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face

    2.5 mg Tablets – blue

          Bottles of 100………………………………………………….NDC 0078-0380-05

    5 mg Tablets – yellow

          Bottles of 100………………………………………………….NDC 0078-0381-05

    10 mg Tablets – white

          Bottles of 100………………………………………………….NDC 0078-0382-05

    Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F).

    [see USP Controlled Room Temperature]

    Protect from light and moisture.

    REFERENCE

    American Psychiatric Association. Diagnosis and Statistical Manual of Mental Disorders. 4th ed. Washington DC: American Psychiatric Association 1994.

    MEDICATION GUIDE

    Focalin® 

    (dexmethylphenidate hydrochloride tablets) CII

    Read the Medication Guide that comes with Focalin® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with Focalin®.

    What is the most important information I should know about Focalin®?

    The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines.

    1. Heart-related problems:

    • sudden death in patients who have heart problems or heart defects

    • stroke and heart attack in adults
    • increased blood pressure and heart rate

    Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

    Your doctor should check you or your child carefully for heart problems before starting Focalin®.

    Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Focalin®.

    Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Focalin®.

    2. Mental (Psychiatric) problems:

    All Patients

    • new or worse behavior and thought problems

    • new or worse bipolar illness
    • new or worse aggressive behavior or hostility

    Children and Teenagers

    • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

    Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

    Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Focalin®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

    What Is Focalin®?

    Focalin® is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Focalin® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

    Focalin® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

    Focalin® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Focalin® in a safe place to prevent misuse and abuse. Selling or giving away Focalin® may harm others, and is against the law.

    Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

    Who should not take Focalin®?

    Focalin® should not be taken if you or your child:

    • are very anxious, tense, or agitated

    • have an eye problem called glaucoma
    • have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard to control repeated movements or sounds.
    • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
    • are allergic to anything in Focalin®. See the end of this Medication Guide for a complete list of ingredients.

    Focalin® should not be used in children less than 6 years old because it has not been studied in this age group.

    Focalin® may not be right for you or your child. Before starting Focalin® tell your or your child’s doctor about all health conditions (or a family history of) including:

    • heart problems, heart defects, high blood pressure

    • mental problems including psychosis, mania, bipolar illness, or depression
    • tics or Tourette’s syndrome
    • seizures or have had an abnormal brain wave test (EEG)

    Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

    Can Focalin® be taken with other medicines?

    Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Focalin® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Focalin®.

    Your doctor will decide whether Focalin® can be taken with other medicines.

    Especially tell your doctor if you or your child takes:

    • anti-depression medicines including MAOIs

    • seizure medicines
    • blood thinner medicines
    • blood pressure medicines
    • cold or allergy medicines that contain decongestants

    Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

    Do not start any new medicine while taking Focalin® without talking to your doctor first.

    How should Focalin® be taken?

    • Take Focalin exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.

    • Take Focalin® twice a day, at least 4 hours apart.
    • Focalin® can be taken with or without food.
    • From time to time, your doctor may stop Focalin® treatment for a while to check ADHD symptoms.
    • Your doctor may do regular checks of the blood, heart, and blood pressure while taking Focalin®. Children should have their height and weight checked often while taking Focalin®. Focalin® treatment may be stopped if a problem is found during these check-ups.
    • If you or your child takes too much Focalin® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

    What are possible side effects of Focalin®?

    See “What is the most important information I should know about Focalin®?” for information on reported heart and mental problems.

    Other serious side effects include:

    • Serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever)

    • slowing of growth (height and weight) in children
    • seizures, mainly in patients with a history of seizures
    • eyesight changes or blurred vision

    Common side effects include:

    • stomach ache       • decreased appetite

    • nausea             • fever

    Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

    This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

    How should I store Focalin®?

    • Store Focalin® in a safe place at room temperature, 59 to 86° F (15 to 30° C).

    • Keep Focalin® and all medicines out of the reach of children.

    General information about Focalin®

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Focalin® for a condition for which it was not prescribed. Do not give Focalin® to other people, even if they have the same condition. It may harm them and it is against the law.

    This Medication Guide summarizes the most important information about Focalin®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Focalin® that was written for healthcare professionals. For more information about Focalin® call 1-888-669-6682.

    What are the ingredients in Focalin®?

    Active Ingredient: dexmethylphenidate hydrochloride

    Inactive Ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.

    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.

    Manufactured for:

    Novartis Pharmaceuticals Corporation

    East Hanover, NJ 07936

    By:

    Mikart, Inc.

    Atlanta, GA 30318

    © Novartis

    T2012-112/T2012-113

    May 2012/May 2012

    PRINCIPAL DISPLAY PANEL

    Package Label  2.5 mg

    Rx Only             NDC 0078-0380-05

    Focalin®

    dexmethylphenidate hydrochloride

    2.5 mg

    100 Tablets

    Dispense with Medication Guide attached or provided separately.

    PRINCIPAL DISPLAY PANEL

    Package Label  5 mg

    Rx Only             NDC 0078-0381-05

    Focalin®

    dexmethylphenidate hydrochloride

    5 mg

    100 Tablets

    Dispense with Medication Guide attached or provided separately.

    PRINCIPAL DISPLAY PANEL

    Package Label  10 mg

    Rx Only             NDC 0078-0382-05

    Focalin®

    dexmethylphenidate hydrochloride

    10 mg

    100 Tablets

    Dispense with Medication Guide attached or provided separately.

    Focalin 

    dexmethylphenidate hydrochloride tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0380
    Route of Administration ORAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color BLUE (Blue) Score no score
    Shape FREEFORM (D-shaped) Size 18mm
    Flavor Imprint Code
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0078-0380-05 100 TABLET (100 TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021278 11/30/2001
    Focalin 

    dexmethylphenidate hydrochloride tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0381
    Route of Administration ORAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color YELLOW Score no score
    Shape FREEFORM (D-shaped) Size 18mm
    Flavor Imprint Code D;5
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0078-0381-05 100 TABLET (100 TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021278 11/30/2001
    Focalin 

    dexmethylphenidate hydrochloride tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0382
    Route of Administration ORAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color WHITE Score no score
    Shape FREEFORM (D-shaped) Size 18mm
    Flavor Imprint Code D;10
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0078-0382-05 100 TABLET (100 TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021278 11/30/2001
    Labeler - Novartis Pharmaceuticals Corporation (002147023)

    Revised: 05/2012   Novartis Pharmaceuticals Corporation


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