Duchesnay

Designed with the safety of the mother and child in mind, Diclegis can provide you with morning sickness [1] symptom relief throughout the day when taken as prescribed.

  • Diclegis is a FDA Pregnancy category A medicine. Pregnancy Category A means that a medicine has been tested in pregnant women and their babies did not have any problems related to using this medicine[2]*.
  • Diclegis is the only FDA-approved medicine that will treat the medical condition know as Nausea and Vomiting of Pregnancy (NVP), which is commonly called morning sickness [1].
  • Diclegis has a delayed-release formulation and a dosing schedule that helps you control symptoms throughout the day. Diclegis should be taken as a daily prescription and not on a as-needed basis.
  • Diclegis is a fixed-dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a vitamin B analog. The combination of ingredients in Diclegis (doxylamine succinate, 10m. and pyridoxine hydrochloride. 10mg) has been commercially available as the active ingredients in Diclectin® for more than 30 years in Canada [3].

Talk to your healthcare provider to learn if Diclegis may be right for you. Visit www.declegis.com for more information.

*although no harm has ever been observed, you should still speak to your healthcare provider about any potential risks.

Indication

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.

Important Safety Information

Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. Use the MAOIs may also prolong and intensify the antocholinergic (drying) effects of antihistamines.

The most common side effect of Diclegis is drowsiness. You 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 your healthcare provider.

Do not take Diclegis with alcohol or sedating medicines, including other antihistamines (present in some cough and cold medications), opiates, or sleep aids, because severe drowsiness can happen or become worse, causing falls or accidents.

Diclegis should be used with caution in women who have: (1) asthma, (2) increased blood pressure, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction.

Fatalities have been reported from doxylamine overdose in children. Children appear to be a high risk for cardiorespiratory arrest. However, the safety and effectiveness of Diclegis in children younger than 18 years 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.

The FDA granted Diclegis Pregnancy Category A status, which means that the results of controlled studies have not shown increased risk to an unborn baby during  pregnancy.

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 diseases may be particularly vulnerable to the sedative effects of Diclegis resulting in worsening of their apnea and respiratory conditions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information

Tablet(s) shown are not actual size.

References  1. ACOG Committee on Practice Bulletins – Obstetrics. ACOG practice bulletin. Clinical management guidelines for obstetrician0gynecologists. Number52, April 2004. Nausea and vomiting of pregnancy. Obstet Gynecol. 2004; 103(4)803-815. 2. U.S. Department of Health and Human Services, Office on Women’s Health; Pregnancy and Medicines Frequently Asked Questions. Available at http://www.womenshealth.gov. 3. Ornstein M, Einarson A, Koren G. Benectin/Diclectin for morning sickness: a Canadian follow-up of an American tragedy. Reprod Toxicol 1995;(1):1-6.

2013-0132-01 Oct 2013