DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE tablet, delayed release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Bryant Ranch Prepack

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 tablets have not been studied in women with hyperemesis gravidarum. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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 delayed-release tablets [see Drug Interactions (7.1)] . Risk Summary Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for the treatment of nausea and vomiting of pregnancy

Resumo do produto:

NDC: 63629-8358-1: 30 Tablets in a BOTTLE

Status de autorização:

New Drug Application Authorized Generic

Características técnicas

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE
SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE
BRYANT RANCH PREPACK
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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) 05/2018
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)
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)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets containing 10 mg doxylamine succinate and 10
mg pyridoxine hydrochloride. (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 delayed-release tablets until cleared to do so by a
healthcare p