Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride / Codeine Phosphate

Pronunciation: KLOR-fen-IR-a-meen MAL-ee-ate/SOO-doe-e-FED-rin HYE-droe-KLOR-ide/KOE-deen FOS-fate
Class: Antitussive combination

Trade Names

Phenylhistine DH
- Liquid chlorpheniramine 2 mg, pseudoephedrine 30 mg, codeine 10 mg per 5 mL

Zodryl DAC 25
- Suspension chlorpheniramine 1.665 mg, pseudoephedrine 25 mg, codeine 5 mg per 5 mL

Zodryl DAC 30
- Suspension chlorpheniramine 1.43 mg, pseudoephedrine 21.43 mg, codeine 5 mg per 5 mL

Zodryl DAC 35
- Suspension chlorpheniramine 1.25 mg, pseudoephedrine 18.75 mg, codeine 5 mg per 5 mL

Zodryl DAC 40
- Suspension chlorpheniramine 1.11 mg, pseudoephedrine 16.665 mg, codeine 5 mg per 5 mL

Zodryl DAC 50
- Suspension chlorpheniramine 2 mg, pseudoephedrine 30 mg, codeine 5 mg per 5 mL

Zodryl DAC 60
- Suspension chlorpheniramine 1.43 mg, pseudoephedrine 20 mg, codeine 5 mg per 5 mL

Zodryl DAC 80
- Suspension chlorpheniramine 1 mg, pseudoephedrine 15 mg, codeine 5 mg per 5 mL

Pharmacology

Chlorpheniramine

Competitively antagonizes histamine at H 1 receptor sites.

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Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, which promotes nasal drainage.

Codeine

Suppresses cough reflex.

Indications and Usage

Temporary relief of runny nose, sneezing, and itchy, watery eyes due to hay fever (allergic rhinitis); temporary relief of cough due to minor bronchial irritation and nasal congestion caused by common cold; temporary relief of sinus congestion and pressure.

Contraindications

Hypersensitivity or idiosyncratic reaction to any ingredients of product; severe hypertension; severe coronary artery disease; narrow-angle glaucoma; urinary retention; peptic ulcer; asthma attack; MAOI therapy or for 2 wk after stopping MAOI therapy; newborn or premature infants; pregnant or breast-feeding women.

Dosage and Administration

Maximum dose Adults and Children 12 years of age and older

Chlorpheniramine 16 mg/day; codeine 80 mg/day; pseudoephedrine 240 mg/day.

Children 6 to younger than 12 years of age (greater than 19 to 40 kg)

Chlorpheniramine 8 mg/day; codeine 40 mg/day; pseudoephedrine 120 mg/day.

Children 2 to younger than 6 years of age (greater than 10.5 to 19 kg)

Chlorpheniramine 4 mg/day; codeine 18 mg/day; pseudoephedrine 60 mg/day

Allergic rhinitis symptoms, cough, nasal congestion, sinus congestion and pressure
Adults Phenylhistine DH Usual dosage

10 mL every 4 to 6 h.

Maximum dose

Chlorpheniramine 16 mg/day; codeine 80 mg/day; pseudoephedrine 240 mg/day (40 mL/day).

Children 12 years of age and older Phenylhistine DH Usual dosage

10 mL every 4 to 6 h.

Maximum dose

Chlorpheniramine 16 mg/day; codeine 80 mg/day; pseudoephedrine 240 mg/day (40 mL/day).

Children 6 to younger than 12 years of age Phenylhistine DH Usual dosage

5 mL every 4 to 6 h up to 20 mL/day.

Maximum dose

Chlorpheniramine 8 mg/day; codeine 40 mg/day; pseudoephedrine 120 mg/day (20 mL/day).

Zodryl DAC 80 Usual dosage

10 mL every 4 to 6 h for children weighing greater than 32 to 40 kg.

Maximum dose

Chlorpheniramine 8 mg/day; codeine 40 mg/day; pseudoephedrine 120 mg/day (40 mL/day).

Zodryl DAC 60 Usual dosage

7.5 mL every 4 to 6 h for children weighing greater than 25.5 to 32 kg.

Maximum dose

Chlorpheniramine 8 mg/day; codeine 30 mg/day; pseudoephedrine 120 mg/day (30 mL/day).

Zodryl DAC 50 Usual dosage

5 mL every 4 to 6 h for children weighing greater than 19 to 25.5 kg.

Maximum dose

Chlorpheniramine 8 mg/day; codeine 20 mg/day; pseudoephedrine 120 mg/day (20 mL/day).

Children 2 to younger than 6 years of age Zodryl DAC 40 Usual dosage

4.5 mL every 4 to 6 h for children weighing greater than 17 to 19 kg.

Maximum dose

Chlorpheniramine 4 mg/day; codeine 18 mg/day; pseudoephedrine 60 mg/day (18 mL/day).

Zodryl DAC 35 Usual dosage

4 mL every 4 to 6 h for children weighing greater than 15 to 17 kg.

Maximum dose

Chlorpheniramine 4 mg/day; codeine 16 mg/day; pseudoephedrine 60 mg/day (16 mL/day).

Zodryl DAC 30 Usual dosage

3.5 mL every 4 to 6 h for children weighing greater than 13 to 15 kg.

Maximum dose

Chlorpheniramine 4 mg/day; codeine 14 mg/day; pseudoephedrine 60 mg/day (14 mL/day).

Zodryl DAC 25 Usual dosage

3 mL every 4 to 6 h for children weighing greater than 10.5 to 13 kg.

Maximum dose

Chlorpheniramine 4 mg/day; codeine 12 mg/day; pseudoephedrine 60 mg/day (12 mL/day).

Younger than 2 years of age

Use is not recommended.

General Advice

  • Shake the suspension well before each use.
  • Give with food or milk if GI upset occurs.
  • Use dosing spoon or syringe for pediatric doses.

Storage/Stability

Store at 68° to 77°F. Protect from light.

Drug Interactions

Alcohol, anticholinergics, barbiturates (eg, phenobarbital), tricyclic antidepressants (eg, amitriptyline), other CNS depressants

Effects may be enhanced. Avoid concomitant use with alcohol.

Digitalis

Pseudoephedrine may increase the possibility of cardiac arrhythmias.

MAOIs (eg, isocarboxazid)

May prolong and intensify the effects of chlorpheniramine and increase the effects of pseudoephedrine. Use is contraindicated with or within 2 weeks after stopping and MAOI.

Mecamylamine, methyldopa, reserpine, veratrum alkaloids

Antihypertensive effects may be reduced by pseudoephedrine.

Phenytoin

Chlorpheniramine may inhibit the hepatic metabolism of phenytoin.

Laboratory Test Interactions

May interfere with diagnostic test results for skin tests using allergen extracts.

Adverse Reactions

Cardiovascular

Fast, slow, or pounding heartbeat; hypertension; hypotension; orthostatic hypotension; palpitation syncope.

CNS

Agitation, asthenia, dyskinesia, confusion, depression, disorientation, dizziness, drowsiness, euphoria, excitability, facial dyskinesia, false sense of well-being, feeling faint, feeling of relaxation, headache, insomnia, irritability, light-headedness, nervousness, restlessness, sedation, somnolence, tremors, unusual tiredness or weakness, vertigo.

Dermatologic

Dermatitis, erythema, excessive perspiration, pruritus, rash, redness or flushing of the face, urticaria.

EENT

Blurred vision, diplopia, hypermetropia, increased lacrimation, labyrinthitis, mydriasis, nasal stuffiness, photophobia, tinnitus.

GI

Abdominal distention or pain, acute pancreatitis, constipation, decreased gastric motility, diarrhea, dry mouth, dyspepsia, epigastric distress, loss of or increased appetite, nausea, vomiting.

Genitourinary

Dysuria, irritative bladder symptoms, polyuria, urethral spasm, urinary retention.

Hypersensitivity

Allergic laryngospasm, atelectasis, bronchospastic allergic reaction, hives, itching, swelling of the face.

Respiratory

Dryness of the pharynx and respiratory passages, laryngismus, respiratory depression, wheezing or trouble breathing.

Miscellaneous

Drug fever, general feeling of discomfort or illness, shock-like state.

Precautions

Monitor

Assess for allergy symptoms (eg, cough, rhinitis, nasal congestion, sneezing, itching, watery eyes) before and periodically throughout therapy. Monitor patient for nervousness, dizziness, and insomnia.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Not recommended in children younger than 2 y of age ( Zodryl DAC ). Consult a doctor before use in children younger than 6 y of age ( Phenylhistine DH ).

Elderly

Use with caution.

Renal Function

Use with caution.

Hepatic Function

Use with caution.

Special Risk Patients

Do not use in patients with diabetes, hypertension, heart disease, or thyroid disease. Use with caution in patients with Addison disease, asthma, increased IOP, prostatic hypertrophy, urethral stricture, pulmonary disease, or shortness of breath, or whenever ventilatory function is depressed, and in postoperative or debilitated patients.

Hazardous Tasks

Use caution while preforming tasks requiring mental alertness.

Chronic cough

Use with caution in patients with persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or with a cough accompanied by excessive phlegm.

Chronic use

May result in obstructive bowel disease, especially in patients with underlying intestinal motility disorders.

Drug abuse/dependence

Has abuse potential.

Overdosage

Symptoms

Apnea, bradycardia, cardiopulmonary arrest, circulatory collapse, cold and clammy skin, decreased mental alertness, extreme somnolence progressing to stupor or coma, hallucinations, hypotension, medullary paralysis, miosis, respiratory and CNS depression, sedation, seizures, shock, skeletal muscle flaccidity, vasodilation.

Patient Information

  • Advise caregiver to use dosing spoon or syringe when giving to children.
  • Advise patient to take with food or milk if GI upset occurs.
  • Advise patient to take last dose late in the afternoon or early evening to reduce chance of drug causing sleeplessness.
  • Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient to not double the dose to catch up.
  • Advise patient that if allergy symptoms are not controlled, not to increase the dose of medication but to inform health care provider.
  • Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to avoid alcohol and other CNS depressants because of risk of excessive sedation.
  • Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised by health care provider.
  • If patient is to have allergy skin testing, advise to not take the medication for at least 6 days before the skin testing.
  • Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: dizziness, nervousness, sleeplessness.
  • Advise lactating women not to breast-feed.

Copyright © 2009 Wolters Kluwer Health.

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