Medication Guide App

Dextromethorphan / Pseudoephedrine / Chlorpheniramine

Pronunciation: DEX-troe-meth-OR-fan/SOO-doe-e-FED-rin/klor-fen-IR-a-meen
Class: Antitussive, Decongestant, Antihistamine

Trade Names

AccuHist PDX
- Drops dextromethorphan hydrobromide 3 mg, pseudoephedrine hydrochloride 9 mg, chlorpheniramine maleate 0.8 mg per mL

Atuss DS Tannate
- Suspension dextromethorphan hydrobromide 30 mg (as 60 mg tannate), pseudoephedrine hydrochloride 30 mg (as 60 mg tannate), chlorpheniramine maleate 4 mg (as 8 mg tannate) per 5 mL

Dicel DM
- Suspension dextromethorphan tannate 10.5 mg, pseudoephedrine tannate 21.75 mg, chlorpheniramine tannate 2.25 mg per 5 mL
- Tablets, chewable dextromethorphan hydrobromide 10 mg, pseudoephedrine hydrochloride 30 mg, chlorpheniramine maleate 2 mg

KidKare Children's Cough/Cold
- Liquid dextromethorphan hydrobromide 5 mg, pseudoephedrine hydrochloride 15 mg, chlorpheniramine maleate 1 mg per 5 mL

M-End DM
- Liquid dextromethorphan hydrobromide 15 mg, pseudoephedrine hydrochloride 15 mg, chlorpheniramine maleate 2 mg per 5 mL

Maxichlor PSE DM
- Tablets dextromethorphan hydrobromide 20 mg, pseudoephedrine hydrochloride 60 mg, chlorpheniramine maleate 4 mg

Neutrahist PDX
- Drops dextromethorphan hydrobromide 3 mg, pseudoephedrine hydrochloride 9 mg, chlorpheniramine maleate 0.8 mg per mL

Pedia Relief Cough-Cold
- Liquid dextromethorphan hydrobromide 5 mg, pseudoephedrine hydrochloride 15 mg, chlorpheniramine maleate 1 mg per 5 mL

Pediatric Cough & Cold Medicine
- Liquid dextromethorphan hydrobromide 5 mg, pseudoephedrine hydrochloride 15 mg, chlorpheniramine maleate 1 mg per 5 mL

Rescon DM
- Liquid dextromethorphan hydrobromide 10 mg, pseudoephedrine hydrochloride 30 mg, chlorpheniramine maleate 2 mg per 5 mL

Triaminic-D Multi-Symptom Cold Syrup
- Liquid dextromethorphan hydrobromide 7.5 mg, chlorpheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg

Pharmacology

Dextromethorphan

Suppresses cough by central action on cough center in medulla.

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Pseudoephedrine

Stimulates postsynaptic alpha-receptors, resulting in vasoconstriction, which reduces nasal congestion.

Chlorpheniramine

Competitively antagonizes histamine at H 1 receptor sites.

Indications and Usage

Temporary relief of cough and upper respiratory tract symptoms, including nasal and sinus congestion; sneezing; itchy nose or throat; runny nose; and itchy, watery eyes associated with allergy or common cold.

Contraindications

Hypersensitivity to any ingredients of product; severe hypertension; severe coronary artery disease; ischemic heart disease; narrow-angle glaucoma; urinary retention; peptic ulcer; emphysema; chronic bronchitis; as treatment for lower respiratory tract conditions, including asthma; during an asthma attack; concomitant MAOI therapy or for 2 wk after stopping MAOI therapy; newborns or premature infants; pregnancy; breast-feeding mothers.

Dosage and Administration

Maximum dose
Adults and Children 12 y of age and older

Chlorpheniramine maleate 16 mg/day, pseudoephedrine hydrochloride 240 mg/day, dextromethorphan hydrobromide 120 mg/day, according to the prescribing information.

Children 6 to 12 y of age

Chlorpheniramine maleate 8 mg/day, pseudoephedrine hydrochloride 120 mg/day, dextromethorphan hydrobromide 60 mg/day, according to the prescribing information.

Children 2 to younger than 6 y of age

Chlorpheniramine maleate 4 mg/day, pseudoephedrine hydrochloride 30 mg/day, dextromethorphan hydrobromide 30 mg/day, according to the prescribing information.

Children 12 to 24 mo of age

Chlorpheniramine maleate 2.4 mg/day, pseudoephedrine hydrochloride 27 mg/day, dextromethorphan hydrobromide 9 mg/day, according to the prescribing information.

Children 6 to 12 mo of age

Chlorpheniramine maleate 1.6 mg/day, pseudoephedrine hydrochloride 18 mg/day, dextromethorphan hydrobromide 6 mg/day, according to the prescribing information.

Adults and Children 12 y of age and older
Atuss DS

5 to 10 mL every 12 h

Dicel DM suspension

5 to 10 mL up to 4 times daily (40 mL/day).

Dicel DM chewables

2 tablets every 4 to 6 hours, up to 8 tablets/day.

M-End DM

10 mL every 6 h, up to 40 mL/day.

Maxichlor PSE DM

1 tablet every 4 to 6 h, up to 4 per day.

Rescon DM

10 mL every 4 to 6 h, up to 40 mL/day.

Children 6 to younger than 12 y of age
Atuss DS

2.5 to 5 mL every 12 h.

Dicel DM suspension

2.5 to 5 mL up to 4 times daily, up to 20 mL/day.

Dicel DM chewables

1 tablet every 4 to 6 h, up to 4 tablets/day.

KidKare Children's Cough/Cold, Pediatric Cough & Cold Medicine

10 mL every 4 to 6 h, up to 40 mL/day.

M-End DM

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

Maxichlor PSE DM

0.5 tablets every 4 to 6 hours, up to 2 per day.

Neutrahist PDX

2 mL every 4 to 6 h, up to 8 mL/day.

Pedia Relief Cough-Cold , Triaminic-D

10 mL every 6 h, up to 40 mL/day.

Rescon DM

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

Children 2 to younger than 6 y of age
Atuss DS

2.5 mL every 12 h.

Children 2 to 3 y of age
AccuHist PDX

1 mL 4 times daily, up to 4 mL/day.

Children 1 to 2 y of age
AccuHist PDX

0.75 mL four times daily, up to 3 mL/day.

Children 6 to 12 mo of age
AccuHist PDX

0.5 mL four times daily, up to 2 mL/day.

General Advice

  • Advise patient to take with food or milk if GI upset occurs.
  • Shake the suspension well.
  • Do not exceed recommended doses.

Storage/Stability

Store between 68° and 77°F. Protect from light.

Drug Interactions

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

Effects may be enhanced by chlorpheniramine.

Anesthesia (eg, halothane)

May cause serious cardiac arrhythmias.

Antacids

Absorption rate of pseudoephedrine may be increased; kaolin may decrease rate.

Antihypertensives (eg, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effects may be reduced by phenylephrine.

Beta-adrenergic blockers

May potentiate the effects of phenylephrine.

Digoxin

Ectopic pacemaker activity may be increased.

MAOIs (eg, isocarboxazid)

May prolong and intensify the anticholinergic effects of chlorpheniramine and increase the effects of phenylephrine. Dextromethorphan is contraindicated with MAOIs or within 2 wk of discontinuing MAOI therapy.

Opioid antitussives (eg, codeine)

May increase the cough suppressant effects of dextromethorphan.

Laboratory Test Interactions

May interfere with diagnostic test results for skin tests using allergen extracts. In vitro, pseudoephedrine may inhibit the cardiac isoenzyme MB of serum creatine phosphokinase; inhibition becomes complete over 6 h.

Adverse Reactions

Cardiovascular

Cardiac arrhythmias, CV collapse, extrasystoles, hypertension, hypotension, palpitations, tachycardia.

CNS

Dizziness, drowsiness, sedation (most common); anxiety, CNS depression, CNS stimulation, confusion, convulsions, disturbed coordination, dysphoria, euphoria, excitation (especially in children), fatigue, hallucinations, headache, hysteria, insomnia, irritability, light-headedness, nervousness, neuritis, paresthesia, restlessness, trembling, tremor, vertigo, weakness.

Dermatologic

Pallor, photosensitivity, pruritus, rash, skin eruptions, urticaria.

EENT

Dryness of nose and throat (most common); acute labyrinthitis, blurred vision, diplopia, tinnitus, visual disturbances.

GI

Dryness of mouth (most common); anorexia, constipation, diarrhea, epigastric discomfort, heartburn, nausea, vomiting.

Genitourinary

Difficult urination, early menses, polyuria, urinary frequency, urinary retention.

Hematologic

Agranulocytosis, hemolytic anemia, hypoplastic anemia, thrombocytopenia.

Hypersensitivity

Anaphylactic shock.

Respiratory

Thickening of bronchial secretions (most common); nasal stuffiness, respiratory difficulty, shortness of breath, tightness of chest, wheezing.

Miscellaneous

Chills, excessive perspiration.

Precautions

Monitor

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


Pregnancy

Category C .

Lactation

Undetermined.

Children

AccuHist PDX

Safety and efficacy in children younger than 6 mo of age not established.

Atuss DS

Safety and efficacy in children younger than 2 y of age not established.

Dicel DM suspension and chewables , KidKare Children's Cough/Cold , M-End DM , Maxichlor PSE DM , Neutrahist PDX , Pedia Relief Cough-Cold , Pediatric Cough & Cold Medicine , Rescon DM , Triaminic-D

Safety and efficacy in children younger than 6 y of age not established.

Elderly

More likely to exhibit adverse reactions (eg, anticholinergic effects, CNS depression, confusion, dizziness, hallucinations, hyperexcitability, hypotension, sedation, seizures). Use with caution.

Renal Function

Use with caution.

Special Risk Patients

Use with caution in patients with hypertension, heart disease, hyperthyroidism or other thyroid disease, increased IOP, diabetes mellitus, prostatic hypertrophy, chronic pulmonary disease, shortness of breath, difficulty breathing, emphysema or chronic bronchitis, history of bronchial asthma, cough that occurs with too much phlegm (mucus) or chronic cough that lasts, GI or pyloroduodenal obstruction, or urinary bladder neck obstruction, children with atopic disease, and in patients who are sedated or debilitated and confined to supine position.

Paradoxical effect

Antihistamines may cause excitation, particularly in children.

Phenylketonurics

Some of these products may contain phenylalanine.

Overdosage

Symptoms

Chlorpheniramine

Anticholinergic effects, apnea, ataxia, blurred vision, CNS depression or stimulation, coma, convulsions, CV collapse, death, dizziness, excitation, fever, fixed and dilated pupils, flushed face, GI symptoms, hallucinations, hyperthermia, hypotension, incoordination, insomnia, sedation, tinnitus, tremors, tremors.

Pseudoephedrine

Abdominal cramps, anorexia, anxiety, cardiac arrhythmias, cerebral hemorrhage, CNS depression, CNS stimulation, confusion, convulsions, delirium, diarrhea, difficulty in micturition, dizziness, dry mouth, fear, flushing, hallucination, headache, hyperactive reflexes, hyperglycemia, hypertension with subsequent hypotension and circulatory collapse, hypokalemia, insomnia, irritability, labored breathing, metallic taste, mydriasis, nausea, pallor, palpitation, panic, pulmonary edema, respiratory depression, restlessness, tachycardia, tachypnea or hyperpnea, talkativeness, tremor, urinary retention, vomiting, weakness.

Dextromethorphan

Ataxia, blurred vision, CNS excitement, coma/unconsciousness, confusion, convulsive seizures, cyanosis, dizziness, drowsiness, hallucination, mania, nausea, nystagmus, opisthotonos, psychosis, respiratory depression, seizures, shallow respirations, stupor, tachycardia, urinary retention, vomiting.

Patient Information

  • Advise caregiver to use dosing spoon or oral syringe for children's doses.
  • Advise patients to shake suspension well before administering dose.
  • 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.
  • If patient is to have allergy skin testing, advise to not take the medication for at least 72 h before the skin testing.
  • Instruct patient to report any of the following symptoms to health care provider: dizziness, nervousness, sleeplessness.

Copyright © 2009 Wolters Kluwer Health.

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