Pharmacological Class:
Antihistamine + Vit. B6 analog.
Active Ingredient(s):
Doxylamine succinate 10mg, pyridoxine HCl 10mg; delayed-release tablets.
Company
Duchesnay USA, Inc.
Indication(s):
Treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
Limitations of use: has not been studied in women with hyperemesis gravidarum.
Pharmacology:
The mechanism of action of Diclegis is unknown.
Clinical Trials:
A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of Diclegis in the treatment of NVP. Adult women ≥18 years of age and 7–14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to 14 days of Diclegis or placebo. Two tablets of Diclegis were administered at bedtime on Day 1. If symptoms of nausea and vomiting persisted into the afternoon hours of Day 2, the woman was directed to take her usual dose of two tablets at bedtime that night and, beginning on Day 3, to take one tablet in the morning and two tablets at bedtime. Based upon assessment of remaining symptoms at her clinic visit on Day 4 (± 1 day), the woman may have been directed to take an additional tablet mid-afternoon. A maximum of four tablets (one in the morning, one in the mid-afternoon and two at bedtime) were taken daily. Over the treatment period, 19% of Diclegis-treated patients remained on two tablets daily, 21% received three tablets daily, and 60% received four tablets daily.
The primary efficacy endpoint was the change from baseline at Day 15 in the Pregnancy Unique-Quantification of Emesis (PUQE) score. The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). Baseline was defined as the PUQE score completed at the enrollment visit.
At baseline, the mean PUQE score was 9 in the Diclegis arm and 8.8 in the placebo arm. There was a 0.7 (95% confidence interval 0.2 to 1.2; P= 0.006) mean decrease (improvement in nausea and vomiting symptoms) from baseline in PUQE score at Day 15 with Diclegis vs. placebo.
Legal Classification:
Rx
Adults:
Swallow whole. Take on empty stomach with water. Day 1: initially 2 tabs at bedtime; continue same dose next day if symptoms adequately controlled. If symptoms persist into afternoon of Day 2, take usual dose of 2 tabs at bedtime that night, and then starting on Day 3 take 3 tabs (1 tablet in AM and 2 tabs at bedtime); continue if symptoms adequately controlled. If symptoms persist, starting on Day 4 take 4 tabs (1 tab in the AM, 1 tab mid-afternoon, and 2 tabs at bedtime). Max 4 tabs daily.
Children:
<18 years: not established.
Contraindication(s):
Concomitant MAOIs; may prolong and intensify anticholinergic effects.
Warnings/Precautions:
Asthma. Increased intraocular pressure. Narrow angle glaucoma. Stenosing peptic ulcer. Pyloroduodenal obstruction. Urinary bladder-neck obstruction. Reassess for continued need of treatment as pregnancy progresses. Pregnancy (Category A). Nursing mothers: not recommended.
Interaction(s)
See Contraindications. Concomitant alcohol, other CNS depressants (eg, hypnotic sedatives, tranquilizers): not recommended. Concomitant food may delay onset of action and reduce absorption.
Adverse Reaction(s)
Somnolence, severe drowsiness, falls, other accidents.
How Supplied:
Tabs—100
LAST UPDATED:
7/3/2013
