Brompheniramine / Phenylephrine / Dextromethorphan

Pronunciation: (BROME-fen-IR-a-meen/FEN-il-EF-rin / DEX-troe-meth-OR-fan)Class: Antihistamine, Decongestant, Antitussive

Trade Names:Alahist DM- Liquid brompheniramine maleate 4 mg, phenylephrine hydrochloride 7.5 mg, dextromethorphan hydrobromide 15 mg per 5 mL

Trade Names:Balacall DM- Syrup brompheniramine maleate 2 mg, phenylephrine hydrochloride 5 mg, dextromethorphan hydrobromide 10 mg per 5 mL

Trade Names:BroveX PEB DM- Liquid brompheniramine maleate 4 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg per 5 mL

Trade Names:Dimaphen DM (Children's)- Elixir brompheniramine maleate 1 mg, phenylephrine hydrochloride 2.5 mg, dextromethorphan hydrobromide 5 mg per 5 mL

Trade Names:Dimetapp Cold & Cough (Children's)- Liquid brompheniramine maleate 1 mg, phenylephrine hydrochloride 2.5 mg, dextromethorphan hydrobromide 5 mg per 5 mL

Trade Names:LoHist-DM- Syrup brompheniramine maleate 2 mg, phenylephrine hydrochloride 5 mg, dextromethorphan hydrobromide 10 mg per 5 mL

Trade Names:Neo DM- Suspension brompheniramine tannate 10 mg, phenylephrine tannate 25 mg, dextromethorphan tannate 30 mg per 5 mL

Trade Names:Tusdec-DM- Liquid brompheniramine maleate 2 mg, phenylephrine hydrochloride 7.5 mg, dextromethorphan hydrobromide 15 mg per 5 mL

Pharmacology

Brompheniramine

Competitively antagonizes histamine at H ₁ receptor sites.

Phenylephrine

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

Dextromethorphan

Suppresses cough by central action on cough center in medulla.

Indications and Usage

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

Contraindications

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

Dosage and Administration

Maximum doseAdults and Children 12 yr of age and older

Brompheniramine maleate 32 mg/day (40 mg/day as tannate); phenylephrine hydrochloride 80 mg/day (100 mg/day as tannate); dextromethorphan hydrobromide 160 mg/day (120 mg/day as tannate).

Children 6 to 12 yr of age

Brompheniramine maleate 16 mg/day (20 mg/day as tannate); phenylephrine hydrochloride 40 mg/day (50 mg/day as tannate); dextromethorphan hydrobromide 80 mg/day (60 mg/day as tannate).

Children 2 to younger than 6 yr of age

Brompheniramine tannate 10 mg/day; phenylephrine tannate 25 mg/day; dextromethorphan tannate 30 mg/day.

Adults and Children 12 yr of age and older Alahist DM

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

Balacall DM , LoHist-DM

10 mL every 4 h, up to 60 mL/day.

BroveX PEB DM

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

Dimaphen DM (Children's) , Dimetapp Cold & Cough (Children's)

20 mL every 4 h, up to 120 mL/day.

Neo DM

10 mL every 12 h, up to 20 mL/day.

Children 6 to younger than 12 yr of age Alahist DM

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

Balacall DM , LoHist-DM

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

BroveX PEB DM

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

Dimaphen DM (Children's) , Dimetapp Cold & Cough (Children's)

10 mL every 4 h, up to 60 mL/day.

Neo DM

5 mL every 12 h, up to 10 mL/day.

Children 2 to younger than 6 yr of age Neo DM

2.5 mL every 12 h, up to 5 mL/day.

General Advice

• Advise patient to take with food or milk if GI upset occurs.
• Shake the suspension well.

Storage/Stability

Store at room temperature (68° to 77°F). Protect from freezing.

Drug Interactions

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

Effects may be enhanced by brompheniramine.

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 brompheniramine 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, hypertension, hypotension, palpitations, tachycardia.

CNS

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

Dermatologic

Flushing of the face, pallor, photosensitivity, pruritus, rash, urticaria.

EENT

Acute labyrinthitis, blurred vision, diplopia, dryness of nose and throat, tinnitus, visual disturbances.

GI

Anorexia, constipation, diarrhea, dryness of mouth, epigastric discomfort, heartburn, nausea, vomiting.

Genitourinary

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

Hematologic

Agranulocytosis, hemolytic anemia, thrombocytopenia.

Hypersensitivity

Anaphylactic shock.

Respiratory

Nasal stuffiness, respiratory difficulty, shortness of breath, thickening of bronchial secretions, 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

Contraindicated in breast-feeding mothers.

Children

BroveX PEB DM , Neo DM

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

Alahist DM , Balacall DM , Dimaphen DM , LoHist-DM , Tusdec-DM

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

Elderly

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

Special Risk Patients

Use with caution in patients with hypertension, heart disease, hyperthyroidism or other thyroid disease, narrow-angle glaucoma or increased IOP, diabetes mellitus, prostatic hypertrophy, chronic pulmonary disease, shortness of breath, difficulty in breathing, emphysema, history of bronchial asthma, GI obstruction, or urinary bladder neck obstruction, and in children with atopic disease.

Paradoxical effect

Antihistamines may cause excitation, particularly in children.

Phenylketonurics

Some products may contain phenylalanine.

Overdosage

Symptoms

Brompheniramine

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

Phenylephrine

Abdominal cramps, anorexia, cardiac arrhythmias, cerebral hemorrhage, CNS stimulation, convulsions, delirium, diarrhea, difficulty in micturition, dizziness, dry mouth, fear, flushing, hallucination, headache, hyperactive reflexes, hypertension with subsequent hypotension and circulatory collapse, insomnia, irritability, labored breathing, metallic taste, nausea, pallor, palpitation, pulmonary edema, restlessness, tachycardia, talkativeness, tremor, vomiting, weakness.

Dextromethorphan

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

Patient Information

• Advise caregiver to use dosing spoon or syringe for children's doses.
• 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 dizziness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise patient to get up slowly from a lying or sitting position and to lie down if nausea occurs.
• Advise patient to avoid alcohol and other CNS depressants be cause 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 72 h before the skin testing.
• Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: nervousness, dizziness, sleeplessness.

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