BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE- brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Preferred Pharmaceuticals Inc.

INN (Международно Name):

BROMPHENIRAMINE MALEATE

Композиция:

BROMPHENIRAMINE MALEATE 2 mg in 5 mL

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated 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 inhibitors (MAOIs) (see Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Каталог на резюме:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes: 4 fl oz (118 mL) NDC 68788-7123-1 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
PREFERRED PHARMACEUTICALS INC.
----------
RX ONLY
DESCRIPTION
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and
Dextromethorphan
Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor.
EACH 5 ML (1 TEASPOONFUL) CONTAINS:
Brompheniramine Maleate, USP . . . . . . . . 2 mg
Pseudoephedrine Hydrochloride, USP . . . . . 30 mg
Dextromethorphan Hydrobromide, USP . . . 10 mg
INACTIVE INGREDIENTS: citric acid anhydrous, FD&C Red #40, glycerin,
melon flavoring,
methylparaben, propylene glycol, purified water, sodium benzoate,
sodium citrate
dihydrate, and sucralose.
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
16
19
2
4
4
4
10
15
Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride
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 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