Medication Guide App

Dextromethorphan Hydrobromide / Phenylephrine Hydrochloride / Chlorpheniramine Maleate

Pronunciation: DEX-troe-meth-OR-fan HYE-droe-BROE-mide/FEN-il-EF-rin HYE-droe-KLOR-ide/klor-fen-IR-a-meen MAL-ee-ate
Class: Upper respiratory combination

Trade Names

AMBI 10PEH/4CPM/20DM
- Tablets dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 4 mg

Bronkids
- Drops dextromethorphan hydrobromide 2.75 mg, phenylephrine hydrochloride 1.5 mg, chlorpheniramine maleate 0.6 mg per mL
- Liquid dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 2 mg per 5 mL

Corfen-DM
- Liquid dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 4 mg per 5 mL

De-Chlor DM
- Liquid dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 2 mg per 5 mL

Donatussin DM
- Drops dextromethorphan hydrobromide 3 mg, phenylephrine hydrochloride 1.5 mg, chlorpheniramine maleate 1 mg per mL

Ed-A-Hist DM
- Liquid dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 4 mg per 5 mL

Father John's Medicine Plus
- Solution dextromethorphan hydrobromide 10 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 4 mg per 5 mL

Maxichlor PEH DM
- Tablets dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 4 mg

Nasohist DM
- Drops dextromethorphan hydrobromide 3 mg, phenylephrine hydrochloride 2 mg, chlorpheniramine maleate 1 mg per mL

Neo DM
- Drops dextromethorphan hydrobromide 2.75 mg, phenylephrine hydrochloride 1.75 mg, chlorpheniramine maleate 0.75 mg per mL

NeoTuss Plus
- Liquid dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 7.5 mg, chlorpheniramine maleate 4 mg per 5 mL

PE-Hist DM
- Syrup dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 5 mg, chlorpheniramine maleate 2 mg per 5 mL

Phenabid DM
- Tablets dextromethorphan hydrobromide 28 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 3.5 mg

TGQ 15DM/5PEH/2CPM
- Liquid dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 5 mg, chlorpheniramine maleate 2 mg per 5 mL

Pharmacology

Dextromethorphan

Suppresses cough by central action on cough center in medulla.

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Phenylephrine

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 coughs and upper respiratory tract symptoms, including nasal congestion, associated with allergy or common cold.

Contraindications

Hypersensitivity to any ingredients of product; severe hypertension; ventricular tachycardia; severe coronary artery 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; breast-feeding women.

Dosage and Administration

Maximum dose
Adults and Children 12 y age and older

Dextromethorphan 120 mg, phenylephrine 80 mg, chlorpheniramine 32 mg per day, according to the prescribing information.

Children 6 to 12 y of age

Dextromethorphan 60 mg, phenylephrine 40 mg, chlorpheniramine 16 mg per day, according to the prescribing information.

Children 2 to younger than 6 y

Dextromethorphan 30 mg, phenylephrine 20 mg, chlorpheniramine 8 mg per day, according to the prescribing information.

Children 12 to 24 mo of age

Dextromethorphan 24 mg, phenylephrine 14 mg, chlorpheniramine 8 mg per day, according to the prescribing information.

Children 6 to 12 mo of age

Dextromethorphan 12 mg, phenylephrine 10.5 mg, chlorpheniramine 4 mg per day, according to the prescribing information.

Children 3 to 6 mo of age

Dextromethorphan 7.2 mg, phenylephrine 3.6 mg, chlorpheniramine 2.4 mg per day, according to the prescribing information.

Adults P CHLOR DM

Administer each dose up to 4 times daily.

Adults and Children 12 y and older
AMBI 10PEH/4CPM/20DM , Maxichlor PEH DM

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

Corfen-DM

5 mL every 4 to 6 h, up to 30 mL/day.

De-Chlor DM

5 mL every 4 h, up to 30 mL/day.

PE-Hist DM

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

Ed-A-Hist DM

5 mL every 6 h, up to 30 mL/day.

Father John's Medicine Plus

30 mL every 4 h, up to 180 mL/day.

Phenabid DM

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

TGQ 15DM/5PEH/2CPM

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

Children 6 to younger than 12 y
AMBI 10PEH/4CPM/20DM , Maxichlor PEH DM

½ tablet every 4 to 6 h, up to 3 tablets/day.

Donatussin DM , Nasohist DM , Neo DM

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

Corfen-DM

2.5 mL every 4 to 6 h, up to 15 mL/day.

De-Chlor DM

2.5 mL every 4 h, up to 15 mL/day.

PE-Hist DM

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

Ed-A-Hist DM

2.5 mL every 6 h, up to 15 mL/day.

NeoTuss Plus

2.5 mL every 6 to 8 h, up to 10 mL/day.

Phenabid DM

½ tablet every 6 h, up to 3 tablets/day.

TGQ 15DM/5PEH/2CPM

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

Children 2 to younger than 6 y
Donatussin DM , Neo DM

1 mL every 4 to 6 h, up to 4 mL/day.

PE-Hist DM

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

Children 1 to 2 y of age
Bronkids

1 mL every 4 h, up to 6 mL/day.

Children 6 to 12 mo of age
Bronkids

0.75 mL every 4 h, up to 4.5 mL/day.

Storage/Stability

Store at 59° to 86°F.

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.

Antihypertensives (eg, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effects may be reduced by phenylephrine.

Beta-adrenergic blockers

May potentiate the effects of phenylephrine.

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.

Adverse Reactions

Cardiovascular

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

CNS

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

Dermatologic

Flushing, pallor, photosensitivity, pruritus, rash, urticaria.

EENT

Dryness of nose and throat, thickening of bronchial secretions (most common); acute labyrinthitis, 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.

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 dizziness, insomnia, and nervousness. If noted, hold therapy.


Pregnancy

Category C .

Lactation

Undetermined.

Children

AMBI 10PEH/4CPM/20DM , Corfen-DM , De-Chlor DM , Ed-A-Hist DM , Maxichlor PEH DM , Nasohist DM , NeoTuss Plus , Phenabid DM , TGQ 15DM/5PEH/2CPM

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

Bronkids

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

Donatussin DM , Neo DM , PE-Hist DM

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

Father John's Medicine Plus

Safety and efficacy in children younger than 12 y not established.

P CHLOR DM

Safety and effectiveness in children have not been established.

Elderly

More likely to exhibit adverse reactions (eg, anticholinergic effects, CNS depression, confusion, dizziness, hallucinations, hyperexcitability, hypotension, sedation, seizures). 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, history of bronchial asthma, GI 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.

Overdosage

Symptoms

Dextromethorphan

Ataxia, CNS excitement, confusion, convulsive seizures, drowsiness, nystagmus, opisthotonos, respiratory depression.

Phenylephrine

Abdominal cramps, anorexia, bradycardia, cardiac arrhythmias, cerebral hemorrhage, CNS depression or stimulation, 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, premature ventricular beats, pulmonary edema, restlessness, short paroxysms of ventricular tachycardia, tachycardia, tachypnea or hyperpnea, talkativeness, tremor, urinary retention, vomiting, weakness.

Chlorpheniramine

Anticholinergic effects, apnea, ataxia, CNS depression or stimulation, coma, convulsions, CV collapse, death, diminished mental alertness, dizziness, excitation, fever, fixed and dilated pupils, flushed face, hallucinations, hypotension, incoordination, insomnia, sedation, tremors.

Patient Information

  • Advise caregiver to use dosing spoon or oral syringe for children's doses.
  • Advise patient to take with food or milk if GI upset occurs.
  • Advise patient to take last dose in the late 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 the risk of excessive sedation.
  • If patient is to have allergy skin testing, advise them 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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