drug-information.ru

|Brompheniramine Maleate/Pseudoephedrine Hydrochloride/Dextromethorphan Hydrobromide

Brompheniramine Maleate / Pseudoephedrine Hydrochloride / Dextromethorphan Hydrobromide

Trade Names:
Rondec-DM
- Liquid 4 mg brompheniramine, 45 mg pseudoephedrine, 15 mg dextromethorphan

Mechanism of Action

Pharmacology

Competitively antagonizes histamine at H ₁ receptor sites.

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

Suppresses cough by central action on cough center in medulla.

Indications and Usage

Relief of cough and upper respiratory tract symptoms (including nasal congestion) associated with allergy or common cold.

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.

Dosage and Administration

PO 1 tsp (5 mL) 4 times daily.

PO ½ tsp (2.5 mL) 4 times daily.

Storage/Stability

Store syrup at controlled room temperature (46° to 86°F). Keep tightly closed. Avoid exposure to heat.

Drug Interactions

Effects may be enhanced by brompheniramine.

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

Antihypertensive effects may be reduced by pseudoephedrine.

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 arrhythmia; increased heart rate; increased BP.

CNS

Sedation; dizziness; headache; nervousness; excitability in children (rare).

Convulsions; CNS stimulation; hallucinations; tremors; nervousness; insomnia.

Drowsiness; dizziness.

EENT

Diplopia.

GI

Vomiting; diarrhea; dry mouth; nausea; anorexia; heartburn.

GI disturbance.

Genitourinary

Polyuria; dysuria; urinary retention in patients with prostatic hypertrophy.

Dysuria.

Respiratory

Respiratory difficulties.

Miscellaneous

Weakness.

Pallor.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children less than 2 yr not established.

Elderly

Patients 60 yr of age and older are more likely to exhibit adverse effects.

Special Risk Patients

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased IOP, diabetes mellitus, prostatic hypertrophy.

Overdosage

Symptoms

Young children"s predominant symptoms include: excitation, hallucination, ataxia, incoordination, tremors, flushed face, fever, convulsions, fixed and dilated pupils, coma, death; adults" common symptoms include: fever, flushing, excitation, convulsions, postictal depression preceded by drowsiness and coma, respiratory depression

Restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability, insomnia, cardiovascular and renal effects (eg, difficulty in micturition), headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse, dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea, abdominal cramps

Respiratory depression

Patient Information

• Advise patient to take dose every 4 to 6 h as needed, up to 4 times daily, as prescribed.
• Advise patient to take with food 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 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: nervousness, dizziness, sleeplessness.