Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)
Analog Pharma
ORAL
PRESCRIPTION DRUG
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
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white, round, film-coated, delayed-release tablet contains 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and is imprinted on one side with the pink image of a pregnant woman. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are provided as follows: NDC 70505-100-10 Bottles of 100. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.
New Drug Application Authorized Generic
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE ANALOG PHARMA ---------- 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) 10/2022 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 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: Concurre Les hele dokumentet