BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Disponível em:

Proficient Rx LP

DCI (Denominação Comum Internacional):

BROMPHENIRAMINE MALEATE

Composição:

BROMPHENIRAMINE MALEATE 2 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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 63187-664-04

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE
HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
PROFICIENT RX LP
----------
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHAN
HYDROBROMIDE SYRUP
RX ONLY
DESCRIPTION
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. 40. 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.
CLINICAL PHARMACOLOGY
Brompheniramine maleate is a histamine antagonist, specifically an H
-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.