Generic Name: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Brand Name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Substance Name(s):
- BROMPHENIRAMINE MALEATE
- PSEUDOEPHEDRINE HYDROCHLORIDE
- DEXTROMETHORPHAN HYDROBROMIDE
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.
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 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 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.
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.
Toxic Doses 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 mg/kg to 17 mg/kg.
Another 2½-year-old child survived a dose of 300 mg to 900 mg of brompheniramine.
The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.
Treatment 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 short-acting 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.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup is a clear, light pink syrup with a butterscotch flavor.
Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP ……………..
2 mg Pseudoephedrine Hydrochloride, USP ……..
30 mg Dextromethorphan Hydrobromide, USP ……
10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle.
Inactive Ingredients: alcohol, artificial butterscotch flavor, citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose, and FD&C Red No.
It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment.
The pH range is between 3.0 and 6.0.
Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.
Chemical Structure 1 Chemical Structure 2 Chemical Structure 3
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 0574- 1104 -04 1 Pint (473 mL): NDC 0574- 1104 -16
INDICATIONS AND USAGE
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Pediatric Use Safety and effectiveness in pediatric patients below the age of 6 months have not been established ( see DOSAGE AND ADMINISTRATION ).
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup.
It is also not known whether Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 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 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 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, Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup is contraindicated in nursing mothers.
INFORMATION FOR PATIENTS
Information for Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.
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.