BROMFED DM Syrup Ref.[27885] Active ingredients: Brompheniramine Demorphan Pseudoephedrine

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.

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.

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.

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

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.

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.

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.

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

Clinical studies of Bromfed DM Cough Syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.