国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)
Duchesnay USA, Inc.
DOXYLAMINE SUCCINATE
DOXYLAMINE SUCCINATE 10 mg
ORAL
PRESCRIPTION DRUG
DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use DICLEGIS has not been studied in women with hyperemesis gravidarum. DICLEGIS is contraindicated in women with any of the following conditions: Risk Summary DICLEGIS is 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%, respectively. Data Human Data The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A meta-analysis of 16 coh
DICLEGIS 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. DICLEGIS tablets are provided as follows: NDC 55494-100-10 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
DICLEGIS- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE DUCHESNAY USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLEGIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLEGIS. DICLEGIS (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 DICLEGIS 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 • • WARNINGS AND PRECAUTIONS Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using DICLEGIS 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 actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction (5.2) Interference with urine drug screen: DICLEGIS may interfere with urine screening for methadone, opiates and PCP (5.3) ADVERSE REACTIONS The most common adverse reaction with DICLEGIS (≥5 percent and exceeding 完全なドキュメントを読む