DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE tablet, delayed release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Mylan Pharmaceuticals Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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: Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectiv

Produktsammanfattning:

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets are available containing 10 mg of doxylamine succinate, USP and 10 mg of pyridoxine hydrochloride, USP. The 10 mg/10 mg tablets are white to off-white, film-coated, round, unscored tablets imprinted with M over DP in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4615-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep bottle tightly closed. Protect from moisture and light. Do not remove desiccant from bottle. Dispense in original container or equivalent air tight, light resistant container.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE
SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE
MYLAN PHARMACEUTICALS INC.
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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, Concomitant Medical Conditions (5.2) 03/2022
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
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WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reaction with doxylamine succinate and
pyridoxine hydrochloride delayed-
release tablets (≥ 5 percent and exceeding the rate in placebo) is
somnolence. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
Known hypersensitivity to doxylamine succinate, other ethanolamine
derivative antihistamines,
pyridoxine hydrochloride or any