DICLEGIS ®

Clinical pharmacology

Drug UPDATES: DICLEGIS ®- doxylamine succinate and pyridoxine hydrochloride tablet, delayed release
[Drug information / PDF]
Dosing: Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval: 2013

Mechanism of Action: The mechanism of action of DICLEGIS is unknown.

Indications and usage

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

Dosage and administration

Dosage Information
Initially, take two DICLEGIS delayed-release tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).

The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily.
Take on an empty stomach with a glass of water [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do not crush, chew, or split DICLEGIS tablets.
Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for DICLEGIS as her pregnancy progresses.

How supplied

Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride.

Reference

Package Insert

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.