Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE- brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup
Taro Pharmaceuticals U.S.A., Inc.

Rx only

DESCRIPTION

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup 2 mg/30 mg/10 mg per 5 mL is a clear, colorless to slightly yellowish grape flavored solution.

Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate, USP2 mg
Pseudoephedrine Hydrochloride, USP30 mg
Dextromethorphan Hydrobromide, USP10 mg

Inactive Ingredients: citric acid anhydrous, glycerin, grape flavor, methylparaben, propylene glycol, purified water, sodium benzoate and sucrose.

Chemical Structure
(click image for full-size original)
C16 H19 BrN2 ∙C4 H4 O4 M.W. 435.31Brompheniramine Maleate, USP(±)-2- p-Bromo- α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)
Chemical StructureC10 H15 NO∙HClM.W. 201.69Pseudoephedrine Hydrochloride, USP(+)-Pseudoephedrine hydrochloride
Chemical StructureC18 H25 NO∙HBr∙H2 OM.W. 370.32Dextromethorphan Hydrobromide, USP3-Methoxy-17-methyl-9 α, 13 α, 14 α-morphinan hydrobromide monohydrate

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

CLINICAL PHARMACOLOGY

Brompheniramine maleate is a histamine antagonist, specifically an H1 -receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on a-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Indications and Usage

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see Drug Interactions).

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

WARNINGS

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

PRECAUTIONS

General

Because of its antihistamine component, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Monoamine oxidase (MAO) inhibitors

Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

Central nervous system (CNS) depressants

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).

Antihypertensive drugs

Sympathomimetic may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL. It is also not known whether brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate (a component of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg/30 mg/10 mg per 5 mL is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

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