BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE- brompheniramine maleate, pseudoephedrin

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN), Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F), Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)

Available from:

Proficient Rx LP

INN (International Name):

Brompheniramine Maleate

Composition:

Brompheniramine Maleate 2 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral 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: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHANHYDROBROMIDE- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE
HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
PROFICIENT RX LP
----------
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SYRUP
2 MG/30 MG/10 MG PER 5 ML
RX ONLY
DESCRIPTION
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and
Dextromethorphan Hydrobromide Oral
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: artificial butterscotch flavor, citric acid
anhydrous, dehydrated alcohol, FD&C
Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol,
purified water and sodium
benzoate. 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.
C
H BrN ·C H O
M.W. 435.31
Brompheniramine Maleate, USP
(±)-2-_p_-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)
C
H NO · HCl
M.W. 201.69
Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride
16
19
2
4
4
4
10
15
C
H NO · HBr · H O
M.W. 370.32
Dextromethorphan Hydrobromide, USP
3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide
monohydrate
Antihistamine/Nasal Decongestant/Antitussive syrup for oral
administration.
CLINICAL PHARMACOLOGY
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 ga