Useful links and resources

Resources and valuable links around nausea and vomiting of pregnancy (NVP), commonly called Morning Sickness, are listed below:*

Healthcare Professional Resources:

ACOG (American Congress of Obstetricians and Gynecologists)The nation's leading group of physicians providing healthcare for women.*

APGO (Association of Professors of Gynecology and Obstetrics)
Non-profit, membership-based organization for women's health educators.*

WELLMOM OBSTETRICS APP from APGO (Association of Professors of Gynecology and Obstetrics)APGO WellMom "Managing Nausea and Vomiting of Pregnancy (NVP)" is the only app designed to raise awareness of NVP, educating all parties affected by the condition and managing and treating symptoms.

AWHONN (Association of Women's Health, Obstetric and Neonatal Nurses)
Non-profit membership -based organization that promotes the health of women and newborns.*

ACNM (American College of Nurse-Midwives)
Professional association that represents certified nurse-midwives and certified midwives in the United States.*

Bendectin.com
Provides history of Bendectin.*

MotherToBaby.org (formally known as Organization of Teratology Information Specialists)
Non-profit organization dedicated to providing accurate, evidence-based, clinical information to patients and healthcare professionals about exposure during pregnancy and lactation.*

NPWH (National Association of Nurse Practitioners in Women's Health)
Represents nurse practitioners who provide care to women in the primary care setting as well as in women's health specialty practices.*

Expectant Mother Resources:

American Pregnancy Association
Non-profit health organization committed to promoting reproductive and pregnancy wellness through education, research, advocacy and community awareness.*

Everyday Health
Organization that provides advice from medical experts, tips from parents, and health and wellness news. Sections are dedicated to each stage of pregnancy so that women can find the information that is most relevant to them.*

March of Dimes
Non-profit organization focused on preventing birth defects, premature birth and infant mortality. Site provides information and resources for individuals and healthcare professionals to help women have healthy pregnancies and healthy babies.*

Mayo Clinic
Non-profit worldwide leader in medical care, research and education.*

MedlinePlus
National Institutes of Health website offering reliable, up-to-date health information on a variety of topics.*

Parents Magazine: Blogs
Blog that is part of www.parents.com and that delivers the top mom and dad blogs on baby development, parenting advice, tips on raising kids and much more.*

U.S. Department of Health and Human Services Office on Women's Health: Pregnancy
Provides information about what women can do before, during, and after pregnancy to help their babies get a healthy start on life.*

What to Expect
Organization that provides a variety of information for pregnant mothers. Topics include pregnancy symptoms, labor and delivery, pregnancy fitness and much more.*

What to Expect: Word of Mom Blog
A blog written from mothers’ points-of-view. Provides valuable advice, the latest news and inspiration for expectant women.*

*Links to other websites

Links on Duchesnay USA websites to third-party websites are provided merely as a convenience and do not constitute an endorsement of those websites or the products, services, or content found on them. Duchesnay USA has no control over the websites to which it may link, makes no representation or warranty of any kind as to the currency, quality, completeness, or accuracy of that content and shall have no liability or responsibility for any damages or injuries of any kind arising from such content or information. These external websites are governed by their own terms of use and privacy policies to which you are directed.

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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