PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Proficient Rx LP

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution 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.

Proizvod sažetak:

This preparation is a clear oral solution 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) NDC 71205-654-04. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. Distributed by: Slate Run Pharmaceuticals, LLC Columbus, Ohio 43215 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 10000197/01 Revised: 03/2020

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN
HYDROBROMIDE ORAL SOLUTION- PROMETHAZINE HYDROCHLORIDE AND
DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION SOLUTION
PROFICIENT RX LP
----------
PROMETHAZINE DM ORAL SOLUTION
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:
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•HCI, and the following structural formula:
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 t