Clinical studies of brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide 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.
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. 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.
Signs and Symptoms
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. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13-17 mg/kg. Another 2½-year-old child survived a dose of 300-900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.
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 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression.Should CNS hyperactivity or convulsive seizures occur, intravenous shortacting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. 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: 2.5 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.
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:
4 fl oz (118 mL) NDC 63739-723-59
1 pint (473 mL) NDC 63739-723-60
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
KEEP TIGHTLY CLOSED
Dispense in a tight, light-resistant container as defined in the USP
WES Pharma Inc
Westminster, MD – 21157
McKesson Corporation dba SKY Packaging
4971 Southridge Blvd., Suite 101Memphis, TN 38141
|BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, brompheniramine maleate, pseudoephedrine hydrochloride, syrup|
|Labeler — McKesson Corporation dba SKY Packaging (140529962)|
|Wes Pharma Inc||078706898||LABEL (63739-723), MANUFACTURE (63739-723), PACK (63739-723)|
Revised: 06/2020 McKesson Corporation dba SKY Packaging
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