Bromfeddm dm Syrup
BROMFED® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg): For relief of coughs and…
Uses and indications
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.
Side effects
The most frequent adverse reactions to Bromfed® DM Cough 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. System: Urinary frequency, difficult urination.
G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory System: Tightness of chest and wheezing, shortness of breath.
Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
Precautions
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.
General Because of its antihistamine component, Bromfed® DM Cough Syrup 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, Bromfed® DM Cough Syrup 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 Bromfed® DM Cough Syrup 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 Bromfed® DM Cough Syrup 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 Bromfed® DM Cough Syrup. It is also not known whether Bromfed® DM Cough Syrup 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 Bromfed® DM Cough Syrup) 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, Bromfed® DM Cough Syrup 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).Dosage
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.
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 Bromfed® DM Cough Syrup 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.