BROMFED DM- brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Vertical Pharmaceuticals, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Bromfed™ DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral 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 PRECAUTIONS-Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

পণ্য সারাংশ:

Bromfed™ DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral 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 68025-002-04 16 fl oz (473 mL) NDC 68025-002-08

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

BROMFED DM- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
VERTICAL PHARMACEUTICALS, LLC
----------
BROMFED™ DM
VERTICAL PHARMACEUTICALS, LLC
RX ONLY
DESCRIPTION
Bromfed™ DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride,
and
Dextromethorphan Hydrobromide Oral 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.
C16H19BRN2•C4H4O4 M.W. 435.31
BROMPHENIRAMINE MALEATE, USP
(±)-2- _P_-BROMO-Α-2-(DIMETHYLAMINO)ETHYLBENZYLPYRIDINE MALEATE
(1:1)
C10H15NO•HCL M.W. 201.69
PSEUDOEPHEDRINE HYDROCHLORIDE, USP
(+)-PSEUDOEPHEDRINE HYDROCHLORIDE
C18H25NO•HBR•H2O 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
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 endi