PROMETHAZINE DM- dextromethorphan hydrobromide and promethazine hydrochloride solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Proficient Rx LP

INN（国际名称）:

DEXTROMETHORPHAN HYDROBROMIDE

组成:

DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE PRODUCTS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NO

產品總結:

This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL).. Keep tightly closed. Protect from light. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

授权状态:

Abbreviated New Drug Application

产品特点

PROMETHAZINE DM- DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE
HYDROCHLORIDE SOLUTION
PROFICIENT RX LP
----------
PROMETHAZINE DM SYRUP
(PROMETHAZINE HYDROCHLORIDE, USP AND DEXTROMETHORPHAN
HYDROBROMIDE, USP)
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Dextromethorphan hydrobromide 15 mg;
promethazine hydrochloride 6.25 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C
yellow #6, menthol,
methylparaben, orange pineapple flavor, propylene glycol,
propylparaben, purified water, saccharin
sodium, sodium benzoate, sodium citrate and sucrose.
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:
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•HCI, and
the following structural formula:
18
25
2
17
20
2
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
about equal to codeine in
depressing the cough reflex. In therapeutic dosage dextromethorphan
does not inhibit ciliary activity.
Dextromethorphan is rapidly absorbed from the gastro