DICLEGIS- doxylamine succinate and pyridoxine hydrochloride tablet, delayed release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Duchesnay USA, Inc.

INN (Internationale Bezeichnung):

DOXYLAMINE SUCCINATE

Zusammensetzung:

DOXYLAMINE SUCCINATE 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

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.

Berechtigungsstatus:

New Drug Application

Fachinformation

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