BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Padagis US LLC

INN (Nama Internasional):

BROMPHENIRAMINE MALEATE

Komposisi:

BROMPHENIRAMINE MALEATE 2 mg in 5 mL

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

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

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
PADAGIS US LLC
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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,
1
making it useful as a nasal decongestant.