DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- doxylamine succinate and pyridoxine hydrochloride, delayed release tablets 10

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)

Disponibil de la:

Par Pharmaceutical, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.   Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.   Doxylamine succinate and pyridoxine hydrochloride is contraindicated in women with any of the following conditions:   - Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride [see Drug Interactions (7.1)].  Risk Summary Doxylamine succinate and pyridoxine hydrochloride is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks a

Rezumat produs:

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white, round, biconvex, film-coated, delayed-release tablet contains 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and is imprinted on one side with “186” in black color. Doxylamine succinate and pyridoxine hydrochloride tablets are provided as follows: NDC 49884-186-01    Bottles of 100. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE
SUCCINATE
AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MG
TABLET, DELAYED RELEASE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXYLAMINE SUCCINATE AND
PYRIDOXINE HYDROCHLORIDE DELAYED-RELEASE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
DELAYED-RELEASE
TABLETS.
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DELAYED-RELEASE
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1976
RECENT MAJOR CHANGES
Warnings and Precautions, Interference with Urine Screen for
Methadone, Opiates and Phencyclidine Phosphate (PCP)
(5.3) 06/2018
INDICATIONS AND USAGE
Doxylamine succinate and pyridoxine hydrochloride delayed-release
tablets are a fixed dose combination drug product of
doxylamine succinate, an antihistamine, and pyridoxine hydrochloride,
a Vitamin B6 analog, indicated for the treatment of
nausea and vomiting of pregnancy in women who do not respond to
conservative management. (1) (1)
DOSAGE AND ADMINISTRATION
Take two tablets daily at bedtime. If symptoms are not adequately
controlled, the dose can be increased to a maximum
recommended dose of four tablets daily (one in the morning, one
mid-afternoon and two at bedtime) as described in the
full prescribing information. (2) (2)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets containing 10 mg doxylamine succinate and 10
mg pyridoxine hydrochloride. (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to doxylamine succinate, other ethanolamine
derivative antihistamines, pyridoxine
hydrochloride or any inactive ingredient in the formulation (4)
Monoamine oxidase (MAO) inhibitors (4, 7)
WARNINGS AND PRECAUTIONS
Activities requiring mental alertness: Avoid engaging in activities
requiring complete mental alertness, such as driving
or operating heavy machinery, while using doxylamine succinate and
pyridoxine hydrochloride until cleare