PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE- promethazine hydrochloride and dextromethorphan hydrobromide syrup

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Disponible desde:

A-S Medication Solutions

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS, Drug Interactions ). Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

Resumen del producto:

Product: 50090-6467 NDC: 50090-6467-0 473 mL in a BOTTLE, PLASTIC NDC: 50090-6467-1 473 mL in a BOTTLE, PLASTIC

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN
HYDROBROMIDE - PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN
HYDROBROMIDE SYRUP
A-S MEDICATION SOLUTIONS
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PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP
(PROMETHAZINE HYDROCHLORIDE 6.25 MG/5 ML & DEXTROMETHORPHAN
HYDROBROMIDE 15 MG/5 ML)
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Dextromethorphan
hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%.
Inactive Ingredients: artificial pineapple flavor, artificial
raspberry flavor, ascorbic acid,
citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate
disodium, FD&C
Yellow No. 6, glycerin, sucrose, methylparaben, purified water,
saccharin sodium,
sodium benzoate, sodium citrate dihydrate and sodium propionate.
Dextromethorphan hydrobromide is a salt of the methyl ether of the
dextrorotatory
isomer of levorphanol, a narcotic analgesic. It is chemically
designated as 3-Methoxy-17-
methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate.
Dextromethorphan
hydrobromide occurs as white crystals sparingly soluble in water and
freely soluble in
alcohol. It has a molecular weight of 370.32, a molecular formula of C
H
NO•HBr•H
O, and the following structural formula:
18
25
2
Promethazine is a racemic compound. Promethazine hydrochloride, a
phenothiazine
derivative, is chemically designated as 10
_H_-Phenothiazine-10-ethanamine, _N_, _N_, α-
trimethyl-, monohydrochloride, (±)-.
Promethazine hydrochloride occurs as a white to faint yellow,
practically odorless,
crystalline powder which slowly oxidizes and turns blue on prolonged
exposure to air. It
is soluble in water and freely soluble in alcohol. It has a molecular
weight of 320.88, a
molecular formula of C
H
N
S•HCl, and the following structural formula:
CLINICAL PHARMACOLOGY
DEXTROMETHORPHAN
Dextromethorphan is an antitussive agent and, unlike the isomeric
levorphanol, it has no
analgesic or addictive properties.
The drug acts centrally and elevates the threshold for coughing. It is