Diclegis® has been shown to be effective at relieving NVP symptoms.
Diclegis® Clinical Trial
A double-blind, randomized, multi-center, placebo-controlled study found a greater reduction in NVP symptoms in women treated with Diclegis® as compared to placebo.
Women 18 years of age or older and 7 to 14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to receive Diclegis® or placebo for 14 days.
Two tablets of Diclegis® were administered at bedtime on Day 1. If symptoms of nausea and vomiting persisted into the afternoon hours on 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 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.
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).
At baseline, the mean PUQE score was 9.0 (standard deviation of 2.1) in the Diclegis® arm and 8.8 (standard deviation of 2.1) in the placebo arm. There was a mean decrease of 0.7 (95% confidence interval: 0.2-1.2, p=0.006) from baseline in PUQE score at Day 15 with Diclegis® compared to placebo, indicating improvement in nausea and vomiting symptoms.
Diclegis® has not been studied in women with hyperemesis gravidarum or in children under 18 years of age.
The most common adverse reaction observed with Diclegis® was somnolence.
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Indication and Important Safety Information
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.
LIMITATIONS OF USE
Diclegis® has not been studied in women with hyperemesis gravidarum.
IMPORTANT SAFETY INFORMATION
Diclegis® is contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation. Diclegis® is also contraindicated in combination with monoamine oxidase inhibitors (MAOIs) as MAOIs intensify and prolong the adverse CNS effects of Diclegis®. Use of MAOIs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.
Diclegis® may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis® until cleared to do so by their healthcare provider.
Use of Diclegis® is not recommended if a woman is concurrently using CNS depressants, such as alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates, and sleep aids. The combination of Diclegis® and CNS depressants could result in severe drowsiness leading to falls or other accidents.
Diclegis® has anticholinergic properties and should be used with caution in women who have: (1) asthma, (2) increased intraocular pressure, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a urinary bladder problem called bladder-neck obstruction.
Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest. However, the safety and effectiveness of Diclegis® in children under 18 years of age have not been established.
Diclegis® is a delayed-release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. If you suspect an overdose or seek additional overdose information, you can contact a poison control center at 1-800-222-1222.
Diclegis® is intended for use in pregnant women.
Women should not breast-feed while using Diclegis® because the antihistamine component (doxylamine succinate) in Diclegis® can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Diclegis® resulting in worsening of their apnea or respiratory conditions.