DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pregnanc

Product summary:

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 100 bottle count is supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white to off white, unscored, round, biconvex film-coated, delayed-release tablet contains 10 mg doxylamine succinate, USP and 10 mg pyridoxine hydrochloride, USP and is printed with “2132 ” on one side with black ink and plain on the other. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are provided as follows: NDC 0591-2132-01 Bottles of 100. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE
SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE
ACTAVIS PHARMA, 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
INDICATIONS AND USAGE
Doxylamine succinate and pyridoxine hydrochloride delayed-release
tablets is 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 provider (5.1)
Central nervous system (CNS) depressants: Concurrent use with alcohol
or other CNS depressants is
not recommended (5.1)
Anticholinergic