Brom fed pdf

The pH range is between 3. 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. 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. For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. 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.

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility. It should be given to a pregnant woman only if clearly needed. 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. 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.

System: Urinary frequency, difficult urination. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted.

Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures. Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug.

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. 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.

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.

System: Urinary frequency, difficult urination. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted.

Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated.

Oxygen, intravenous fluids, and other supportive measures should be employed as indicated. 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. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

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

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. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.