BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Country: 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:

Rhodes Pharmaceuticals L.P.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 (MAOI) inhibitors (see PRECAUTIONS- Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

পণ্য সারাংশ:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup is a clear, light pink-colored syrup with a butterscotch aroma 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
RHODES PHARMACEUTICALS L.P.
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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
aroma.
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: anhydrous citric acid, artificial butterscotch
flavor, ethyl alcohol,
FD&C Red #40, glycerin, methylparaben, propylene glycol, purified
water, sodium
benzoate and sucrose. May also contain sodium citrate for pH
adjustment. The pH range
is between 4.0 and 5.5.
C
H
BRN ∙C H O M.W. 435.31
BROMPHENIRAMINE MALEATE, USP
(±)-2-_P_-BROMO-Α-2-(DIMETHYLAMINO)ETHYLBENZYLPYRIDINE MALEATE (1:1)
16 19
2
4 4
4
C
H
NO ∙ HCL M.W. 201.69
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