START helping your patients with Diclegis® as soon as conservative management fails

The combination of Doxylamine Succinate and Pyridoxine Hydrochloride in Diclegis® has been proven safe and effective.

The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies designed to detect possible teratogenicity. A meta-analysis of 16 cohort and 11 case-control studies reported no increased risk for malformations after first trimester exposure to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride. A second meta-analysis of 12 cohort and 5 case-control studies corroborated these findings: no statistically significant relationships between fetal abnormalities and first trimester exposure to the combination of doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride were observed.

About the combination of Doxylamine Succinate and Pyridoxine Hydrochloride in Diclegis®:

Safe

1st line pharmacotherapy for managing NVP when conservative management fails according to the American College of Obstetricians and Gynecologists (ACOG) and the Association of Professors of Gynecology and Obstetrics (APGO)

60 years of clinical experience 

26 cohort and case-controlled studies showing no increased risk for malformations after first trimester exposure

diclegis pill

Diclegis® may cause somnolence (14% active vs. 12% placebo), as observed in clinical trials, but no additional adverse reactions were observed at an incidence of >/= 5% and the incidence was no higher with Diclegis® than with placebo.

Effective

  • Diclegis® helps control the nausea, retching and vomiting associated with morning sickness
  • Diclegis® is FDA-approved for use throughout pregnancy
  • Delayed-release coating allows medication to achieve peak effectiveness 5-7 hours after dosing
  • Daily dosing of up to 4 tablets ensures effective symptom management all day long

Make Diclegis® your Standard of Care when conservative management fails.

Indication and Important Safety Information

INDICATION

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.

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.

Tablet(s) shown throughout the site are not actual size.

 

Please click here for full Prescribing Information.

 

Site references

  1. Diclegis® Prescribing Information, Bryn Mawr, PA: Duchesnay USA Inc., 2013.
  2. Whitehead, S. A., et al. (1992). “Characterisation of nausea and vomiting in early pregnancy: a survey of 1000 women.” J Obstet Gynecol 12(6): 364-369.
  3. Gadsby, R., et al. (1993). “A prospective study of nausea and vomiting during pregnancy.” Br J Gen Pract 43(371): 245-248.
  4. Vellacott, I. D., et al. (1988). “Nausea and vomiting in early pregnancy.” Int J Gynecol Obstet 27(1): 57-62.
  5. Nausea and Vomiting of Pregnancy, ACOG Practice Bulletin #153: Clinical Management Guidelines for Obstetrician-Gynecologists 2015; 126, 3:e12-e24.
  6. Association of Professors of Gynecology and Obstetrics Continuing Series on Women’s Health: Nausea and Vomiting of Pregnancy, February 2015.
  7. McKeigue, P. M., et al. (1994). “Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies.” Teratology 50: 27-37.