Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)
Mylan Pharmaceuticals Inc.
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: 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
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.
Abbreviated New Drug Application
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE MYLAN PHARMACEUTICALS 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, 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 • • 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 read_full_document