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

INDICATION

Diclegis® is a fixed-dose combination drug product of 10 mg doxylamine succinate, an antihistamine, and 10 mg 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

Contraindications:

Diclegis® is contraindicated in women with any of the following conditions:

  • Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation;
  • Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of Diclegis®.

Warnings and Precautions:

  • Somnolence: 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.
  • Central nervous system (CNS) depressants: 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.
  • Concomitant Medical Conditions: Use Diclegis® with caution in women with (1) asthma, (2) increased intraocular pressure, (3) narrow angle glaucoma, (4) a stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) bladder-neck obstruction.
  • Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP): There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use. Women should be informed that use of Diclegis® may result in false positive urine drug screening for methadone, opiates and PCP.

Adverse Reactions: The most common adverse reaction (≥5 percent and exceeding the rate in placebo) with combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets is somnolence.

Drug-Food Interactions: A food-effect trial demonstrated that the delay in the onset of action of Diclegis® may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, Diclegis® should be taken on an empty stomach with a glass of water.

Use in Specific Populations:

  • Pregnancy: Diclegis® is intended for use in pregnant women.
  • Lactation: Women should not breastfeed 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.
  • Pediatric Use: The safety and effectiveness of Diclegis® in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest.

Overdosage: 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. At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. If you suspect an overdose or seek additional information about overdose treatment, call a poison control center at 1-800-222-1222.

To report suspected adverse reactions, contact Duchesnay Inc. at 1-855-722-7734 or medicalinfo@duchesnayusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

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