Overview
DESCRIPTION Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, sweet, unflavored, pink syrup. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan Hydrobromide, USP 10 mg Inactive Ingredients: citric acid anhydrous, FD&C Red #40, glycerin, methylparaben, purified...
Mechanism of Action
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.
Indications
- 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.
Common Doses
- 10 mL
- 5 mL
- 2.5 mL
Dosage
DOSAGE AND ADMINISTRATION Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Do not exceed 6 doses during a 24-hour period.
Contraindications
- 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 inhibitors (MAOI) (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Side Effects
- ADVERSE REACTIONS The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation. CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria. G.U.
Interactions
- Drug Interactions Monoamine oxidase inhibitors (MAOI) Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAOI and products containing dextromethorphan. In addition, MAOI 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 and MAOI should be avoided (see CONTRAINDICATIONS ).