What you need to know about drugs

Promethazine with Codeine

Promethazine w/Codeine(codeine phosphate, promethazine hcl) – Various

BOXED WARNING

Contraindicated in pediatrics <6 yrs of age. Concomitant administration of promethazine products with other respiratory depressants is associated with respiratory depression, and sometimes death, in pediatrics. Respiratory depression, including fatalities, have been reported with use of promethazine in pediatrics <2 yrs.

OTHER BRAND NAMES

Prometh w/ Codeine (Actavis)

THERAPEUTIC CLASS

Phenothiazine derivative/antitussive

INDICATIONS

Temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold.

ADULT DOSAGE

Adults: 5mL q4-6h. Max: 30mL/24hr. Elderly: Start at lower end of dosing range.

PEDIATRIC DOSAGE

Pediatrics: ≥12 yrs: 5mL q4-6h. Max: 30mL/24hr. 6-<12 yrs: 2.5-5mL q4-6h. Max: 30mL/24hr.

HOW SUPPLIED

Syrup: (Codeine Phosphate-Promethazine Hydrochloride) 10mg-6.25mg/5mL [118mL, 273mL, 473mL]

CONTRAINDICATIONS

Comatose states, treatment of lower respiratory tract symptoms (eg, asthma), pediatric patients <6 yrs.

WARNINGS/PRECAUTIONS

Should only be given to a pregnant woman if clearly needed. Caution in elderly. Codeine: Do not increase dose if cough fails to respond to treatment. May cause/aggravate constipation. Caution in atopic children. Capacity to elevate CSF pressure and respiratory depressant effects may be markedly exaggerated in head injury, intracranial lesions, or with preexisting increase in intracranial pressure. May obscure clinical course in patients with head injuries. Avoid with acute febrile illness with productive cough or in chronic respiratory disease. May produce orthostatic hypotension in ambulatory patients. Give with caution and reduce initial dose with acute abdominal conditions, convulsive disorders, significant hepatic/renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, recent GI or urinary tract surgery, and in the very young, elderly, or debilitated. Use lowest effective dose for the shortest period of time. Potential for abuse and dependence. Promethazine: May impair mental/physical abilities. May lead to potentially fatal respiratory depression; avoid with compromised respiratory function (eg, chronic obstructive pulmonary disease, sleep apnea). May lower seizure threshold; caution with seizure disorders. Leukopenia and agranulocytosis reported, especially when given with other marrow toxic agents; caution with bone marrow depression. Neuroleptic malignant syndrome (NMS) reported; d/c immediately if NMS occurs. Hallucinations and convulsions may occur in pediatrics. Acutely ill pediatric patients who are dehydrated may have increased susceptibility to dystonias. Cholestatic jaundice reported. Caution with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal/bladder-neck obstruction, cardiovascular disease, or with impaired liver function. May increase blood glucose.

ADVERSE REACTIONS

Drowsiness, dizziness, sedation, blurred vision, dry mouth, increased or decreased BP, N/V, constipation, urinary retention, leukopenia, agranulocytosis, respiratory depression, NMS.

DRUG INTERACTIONS

See Boxed Warning. Possible interaction with MAOIs (eg, increased incidence of extrapyramidal effects); consider initial small test dose. Promethazine: May increase, prolong, or intensify the sedative action of other CNS depressants, such as alcohol, sedative/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, TCAs, and tranquilizers; avoid such agents or administer in reduced doses. Reduce dose of barbiturate by at least 1/2 and narcotic analgesic by 1/4-1/2. May reverse vasopressor effect of epinephrine. Caution with other agents with anticholinergic properties and drugs that also affect seizure threshold (eg, narcotics, local anesthetics).

PREGNANCY

Category C, caution in nursing.

MECHANISM OF ACTION

Codeine: Narcotic analgesic/antitussive; primary effects are on CNS and GI tract. Promethazine: Phenothiazine derivative; blocks H1 receptor and provides sedative and antiemetic effects.

PHARMACOKINETICS

Absorption: Well-absorbed. Distribution: Codeine: Crosses placenta; found in breast milk. Metabolism: Codeine: Liver via O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. Promethazine: Liver; sulfoxides and N-demethylpromethazine (metabolites). Elimination: Codeine: Urine (primary; inactive metabolites and free/conjugated morphine), feces (negligible amount; parent compound and metabolites). Promethazine: Urine (metabolites).

ASSESSMENT

Assess for drug hypersensitivity or idiosyncracy, history of drug abuse/dependence, or any other conditions where treatment is contraindicated or cautioned. Assess BP, pregnancy/nursing status, and for possible drug interactions.

MONITORING

Monitor for signs/symptoms of CNS and respiratory depression, constipation, leukopenia, agranulocytosis, cholestatic jaundice, seizures, NMS, orthostatic hypotension, and abuse and dependence. Monitor pediatric patients for hallucinations, convulsions, and dystonias. Monitor glucose levels. Reevaluate 5 days or sooner if cough is unresponsive to treatment.

PATIENT COUNSELING

Instruct to measure medication with an accurate measuring device. Inform that therapy may cause drowsiness and may impair mental and/or physical abilities required for performing potentially hazardous tasks (eg, driving, operating machinery); advise to avoid such activities until it is known that they do not become drowsy or dizzy with the therapy. Avoid the use of alcohol and other CNS depressants while on therapy. Report any involuntary muscle movements. Avoid prolonged sun exposure. Inform that therapy may produce orthostatic hypotension. Inform about risks and the signs of morphine overdose (extreme sleepiness, confusion, shallow breathing). Instruct nursing mothers to watch for signs of morphine toxicity in their infants (eg, increased sleepiness more than usual, difficulty breastfeeding, breathing difficulties, or limpness); notify pediatrician immediately if these signs are noticed or get emergency medical attention.

ADMINISTRATION/STORAGE

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


  • Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Promethazine with Codeine

    Promethazine with Codeine

    Generic Name: codeine and promethazine (KOE deen and proe METH a zeen)

    Brand Name: Codeine Phosphate-Promethazine HCl, Promethazine HCl and Codeine Phosphate, Promethazine with Codeine

    OverviewSide EffectsInteractionsMore…

    What is Promethazine with Codeine (codeine and promethazine)?

    Codeine is a narcotic. It is a pain reliever and a cough suppressant.

    Promethazine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

    The combination of codeine and promethazine is used to treat cold or allergy symptoms such as runny nose, sneezing, and cough.

    Codeine and promethazine may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about Promethazine with Codeine (codeine and promethazine)?

    Tell your doctor about all of your medical conditions before you start taking this medication.

    You should not use this medication if you are allergic to codeine or promethazine, or if you have asthma or other lung disease.

    Codeine and promethazine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

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

    There are many other medicines that can cause interact with promethazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

    What should I discuss with my doctor before taking Promethazine with Codeine (codeine and promethazine)?

    You should not use this medication if you are allergic to codeine or promethazine, or if you have high blood pressure, a blood vessel disorder, or asthma.

    Do not give this medication to a child without medical advice. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

    To make sure you can safely take codeine and promethazine, tell your doctor if you have any of these other conditions:

    • epilepsy or other seizure disorder;

    • asthma, COPD, sleep apnea, or other breathing disorders;
    • glaucoma;
    • a stomach ulcer or digestive obstruction;
    • a weak immune system;
    • Addison’s disease;
    • enlarged prostate, urination problems;
    • high or low blood pressure or heart disease;
    • liver or kidney disease;
    • underactive thyroid;
    • gallbladder disease; or
    • a head injury or brain tumor.

    Codeine and promethazine may be habit forming and should be used only by the person it was prescribed for. Never share codeine and promethazine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

    FDA pregnancy category C. It is not known whether codeine and promethazine will harm an unborn baby. Codeine and promethazine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using codeine and promethazine.

    Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I take Promethazine with Codeine (codeine and promethazine)?

    Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

    Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

    Contact your doctor if your symptoms do not improve within a few days of using codeine and promethazine.

    Store at room temperature away from moisture, heat, and light.

    Keep track of the amount of medicine used from each new bottle. Codeine and promethazine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

    What happens if I miss a dose?

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

    What happens if I overdose?

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

    Overdose symptoms include dizziness, extreme drowsiness, dry mouth, nausea, vomiting, cold and clammy skin, weak pulse, shallow breathing, fainting, seizure (convulsions), or breathing that stops.

    What should I avoid while taking Promethazine with Codeine (codeine and promethazine)?

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

    Drinking alcohol can increase certain side effects of codeine and promethazine.

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

    Promethazine with Codeine (codeine and promethazine) side effects

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

    Call your doctor at once if you have a serious side effect such as:

    • restless muscle movements in your eyes, tongue, jaw, or neck, tremor (uncontrolled shaking);

    • shallow breathing, slow heartbeat;
    • feeling like you might pass out;
    • jaundice (yellowing of the skin or eyes);
    • confusion, agitation, hallucinations, unusual thoughts or behavior;
    • seizure (convulsions);
    • urinating less than usual or not at all; or
    • very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, fainting.

    Less serious side effects may include:

    • dizziness, drowsiness, sleepiness;

    • feeling restless, nervous, or anxious;
    • blurred vision, ringing in your ears;
    • constipation, mild nausea or vomiting;
    • warmth, redness, or tingly feeling under your skin;
    • sleep problems (insomnia);
    • increased sweating;
    • dry mouth; or
    • mild skin rash.

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

    See also: Promethazine with Codeine side effects (in more detail)

    What other drugs will affect Promethazine with Codeine (codeine and promethazine)?

    Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, other pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine and promethazine.

    Many drugs can interact with codeine and promethazine. Below is just a partial list. Tell your doctor if you are using:

    • sedatives or anxiety medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

    • antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil);
    • narcotic pain medicines such as meperidine (Demerol), morphine (MS Contin, MSIR), propoxyphene (Darvon, Darvocet), hydrocodone (Lortab, Vicodin), oxycodone (Percocet, Percodan), fentanyl (Duragesic), codeine (Fiorinal, Fioricet, Tylenol #3);
    • phenobarbital (Luminal), amobarbital (Amytal) or secobarbital (Seconal);
    • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
    • atropine (Donnatal, and others), belladonna, clidinium (Quarzan), dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), methscopolamine (Pamine), and scopolamine (Transderm-Scop).

    This list is not complete and other drugs may interact with codeine and promethazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Next Page → Side Effects

    More Promethazine with Codeine resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Interactions
    • Support Group
    • 2 Reviews - Add your own review/rating

    Compare Promethazine with Codeine with other medications

    • Cough

    Where can I get more information?

    • Your pharmacist can provide more information about codeine and promethazine.

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>