Brompheniramine Maleate / Pseudoephedrine Hydrochloride / Dextromethorphan Hydrobromide

Pronunciation: BROME-fen-IR-a-meen MAL-ee-ate/SOO-doe-e-FED-rin HYE-droe-KLOR-ide/DEX-troe-meth-OR-fan HYE-droe-BROE-mide
Class: Antitussive, Antihistamine, Decongestant

Trade Names

Accuhist DM Pediatric
- Drops brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, dextromethorphan hydrobromide 4 mg per mL

Anaplex-DM Cough
- Syrup brompheniramine maleate 4 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg per 5 mL

Bromaline DM Cough and Cold
- Elixir brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, dextromethorphan hydrobromide 5 mg per 5 mL

Bromdex D
- Syrup brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 50 mg, dextromethorphan hydrobromide 30 mg per 5 mL

Bromfed DM Cough
- Syrup brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg, dextromethorphan hydrobromide 10 mg per 5 mL

Bromphenex DM
- Liquid brompheniramine maleate 4 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg per 5 mL

Bromtapp-DM Cough and Cold
- Liquid brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, dextromethorphan hydrobromide 5 mg per 5 mL

BroveX PSB DM
- Liquid brompheniramine maleate 4 mg, pseudoephedrine hydrochloride 20 mg, dextromethorphan hydrobromide 20 mg per 5 mL

BroveX PSE DM
- Tablets brompheniramine maleate 4 mg, pseudoephedrine hydrochloride 40 mg, dextromethorphan hydrobromide 20 mg

Dallergy DM
- Syrup brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 30 mg, dextromethorphan hydrobromide 15 mg per 5 mL

Neo DM
- Syrup brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 50 mg, dextromethorphan hydrobromide 30 mg per 5 mL

PBM Allergy
- Syrup brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 30 mg, dextromethorphan hydrobromide 15 mg per 5 mL

PediaHist DM
- Drops brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, dextromethorphan hydrobromide 4 mg per mL

PSE Brom DM
- Syrup brompheniramine maleate 4 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg per 5 mL

Q-Tapp DM
- Syrup brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, dextromethorphan hydrobromide 5 mg per 5 mL

Resperal-DM
- Drops brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 12 mg, dextromethorphan hydrobromide 5 mg per mL

Sildec-DM
- Syrup brompheniramine maleate 4 mg, pseudoephedrine hydrochloride 45 mg, dextromethorphan hydrobromide 15 mg per 5 mL

TGQ 50PSE/3BRM/30DM
- Syrup brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 50 mg, dextromethorphan hydrobromide 30 mg per 5 mL

Pharmacology

Brompheniramine

Competitively antagonizes histamine at H 1 receptor sites.

Pseudoephedrine

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

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Dextromethorphan

Suppresses cough by central action on cough center in medulla.

Indications and Usage

Temporary relief of cough and upper respiratory tract symptoms, including nasal congestion, 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; 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 dose
Adults and Children 12 y of age and older

Brompheniramine maleate 32 mg/day; pseudoephedrine hydrochloride 360 mg/day; dextromethorphan hydrobromide 160 mg/day.

Children 6 to 12 y of age

Brompheniramine maleate 16 mg/day; pseudoephedrine hydrochloride 180 mg/day; dextromethorphan hydrobromide 80 mg/day.

Children 2 to younger than 6 y of age

Brompheniramine maleate 8 mg/day; pseudoephedrine hydrochloride 90 mg/day; dextromethorphan hydrobromide 30 mg/day.

Children 12 to 24 mo of age

Brompheniramine maleate 4 mg/day; pseudoephedrine hydrochloride 60 mg/day; dextromethorphan hydrobromide 16 mg/day.

Children 6 to 12 mo of age

Brompheniramine maleate 3 mg/day; pseudoephedrine hydrochloride 45 mg/day; dextromethorphan hydrobromide 12 mg/day.

Children 3 to 6 mo of age

Brompheniramine maleate 2 mg/day; pseudoephedrine hydrochloride 30 mg/day; dextromethorphan hydrobromide 8 mg/day.

Children 1 to 3 mo of age

Brompheniramine maleate 1 mg/day; pseudoephedrine hydrochloride 15 mg/day; dextromethorphan hydrobromide 4 mg/day.

Adults and Children 12 y of age and older Anaplex-DM , PSE Brom DM , TGQ 50PSE/3BRM/30DM

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

Bromaline DM Cough and Cold , Bromtapp-DM Cough and Cold

20 mL every 6 h, up to 80 mL/day.

Bromdex D , Bromphenex DM

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

Bromfed DM

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

BroveX PSB DM , Dallergy DM , PBM Allergy

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

BroveX PSE DM

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

Q-Tapp DM

20 mL every 6 h, up to 80 mL/day.

Sildec-DM

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

Children 6 to younger than 12 y of age Anaplex-DM , PSE Brom DM , TGQ 50PSE/3BRM/30DM

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

Bromaline DM Cough and Cold , Bromtapp-DM Cough and Cold

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

Bromdex D , Neo DM

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

Bromfed DM

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

BroveX PSB DM

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

BroveX PSE DM

One-half tablet every 4 to 6 h, up to 3 tablets/day.

Dallergy DM , PBM Allergy

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

Q-Tapp DM

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

Resperal-DM

2 mL every 4 to 6 h, up to 12 mL/day.

Sildec-DM

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

Children 2 to younger than 6 y of age Bromfed DM

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

Dallergy DM

1.25 to 2.5 mL every 4 to 6 h, up to 10 mL/day.

PSE Brom DM

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

Resperal-DM

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

Sildec-DM

2.5 mL 4 times daily, up to 10 mL/day.

Children 12 to 24 mo of age AccuHist DM Pediatric , PediaHist DM

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

Children 6 to 12 mo of age AccuHist DM Pediatric , PediaHist DM

0.75 mL 4 times daily, up to 3 mL/day.

Children 3 to 6 mo of age AccuHist DM Pediatric , PediaHist DM

0.5 mL 4 times daily, up to 2 mL/day.

Children 1 to 3 mo of age AccuHist DM Pediatric , PediaHist DM

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

General Advice

  • Advise patient to take with food if GI upset occurs.
  • BroveX PSE DM tablets may be split.

Storage/Stability

Store at 46° to 86°F. Keep tightly closed. Avoid freezing or exposure to heat.

Drug Interactions

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

Effects may be enhanced by brompheniramine.

Antihypertensives (eg, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effects may be reduced by pseudoephedrine.

Beta-adrenergic blockers

May potentiate the effects of pseudoephedrine.

MAOIs (eg, isocarboxazid)

May prolong and intensify the anticholinergic effects of brompheniramine and increase the effects of pseudoephedrine. Dextromethorphan is contraindicated with MAOIs.

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

Arrhythmia; CV collapse with hypotension; hypertension; hypotension; palpitations; paresthesia; tachycardia.

CNS

Anxiety; CNS depression; convulsions; disturbed coordination; dizziness; drowsiness; dysphoria; euphoria; excitability (especially in children); fear; hallucinations; headache; hysteria; insomnia; irritability; nervousness; neuritis; restlessness; sedation; tremor; weakness.

Dermatologic

Pallor; photosensitivity; pruritus; rash; urticaria.

EENT

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

GI

Anorexia; constipation; diarrhea; dry mouth; GI disturbances; epigastric discomfort; heartburn; nausea; vomiting.

Genitourinary

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

Hematologic

Agranulocytosis; hemolytic anemia; thrombocytopenia.

Hypersensitivity

Anaphylactic shock.

Respiratory

Respiratory difficulties; shortness of breath; thickening of bronchial secretions; tightness of chest; wheezing.

Miscellaneous

Chills; excessive perspiration.

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. If noted, hold therapy.


Pregnancy

Category C .

Lactation

Contraindicated in breast-feeding mothers.

Children

AccuHist DM Pediatric , PediaHist DM

Safety and efficacy in children younger than 1 mo of age not established.

Anaplex-DM , Bromaline DM Cough and Cold , Bromdex D , Bromtapp-DM Cough and Cold , BroveX PSB DM , BroveX PSE DM , Neo DM , PBM Allergy , Q-Tapp DM , TGQ 50PSE/3BRM/30DM

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

Bromfed DM , Dallergy DM , PSE Brom DM , Resperal-DM , Sildec-DM

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

Bromphenex DM

Safety and efficacy in children younger than 12 years 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.

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, urinary bladder neck obstruction, children with atopic disease, sedated or debilitated patients, or patients confined to supine positions.

Paradoxical effect

Antihistamines may cause excitation, particularly in children.

Overdosage

Symptoms

Brompheniramine

CNS depression or stimulation (especially in children), anticholinergic effects. In small children, symptoms include ataxia, excitation, fever, flushed face, hallucinations, incoordination, and tremors. Convulsion, fixed and dilated pupils, or coma and death may occur in severe cases. In adults, fever and flushing are uncommon. Excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma.

Pseudoephedrine

Abdominal cramps; anorexia; arrhythmias, including ventricular tachycardia, which may lead to hypotension and circulatory collapse; bradycardia; cerebral hemorrhage; CNS depression; CNS stimulation; convulsions; delirium; diarrhea; difficulty in micturition; dry mouth; excitement; flushing; hallucinations; headache; hyperglycemia; hyperpnea; hypertension; insomnia; metallic taste; mydriasis; nausea; pallor; premature ventricular beats; restlessness; severe hypokalemia; tachycardia; tachypnea; tremors; urinary retention; vomiting.

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 not to 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 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.
  • Caution patients about the potential side effects, especially anticholinergic effects (eg, clumsiness; flushing or redness of face; severe drowsiness; severe dryness of mouth, nose, or throat; unsteadiness), blood dyscrasias (eg, fever, sore throat, unusual bleeding or bruising, unusual tiredness or weakness), fast or irregular heartbeat, psychotic episodes, shortness of breath or troubled breathing, and tightness in chest.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web5)