ROSEMONT, Pa., May 21, 2013 /PRNewswire/ -- Duchesnay USA, the first pharmaceutical company dedicated to the health of pregnant women, announces the U.S. market introduction of Diclegis® (doxylamine succinate 10mg and pyridoxine hydrochloride -vitamin B6- 10mg), now available in pharmacies across the country. Diclegis was recently approved by the U.S. Food and Drug Administration (FDA) as the only treatment for nausea and vomiting of pregnancy (NVP), more commonly known as morning sickness.1,2
Diclegis offers pregnant women suffering from NVP a safe and effective option for reducing symptoms when conservative management, such as diet, have failed.1 Diclegis has received a Pregnancy Category A status from the U.S. FDA, which means the results of controlled studies have not shown an increased risk to an unborn baby.1,3
"We believe Diclegis will become an important treatment for healthcare professionals caring for pregnant women with nausea and vomiting of pregnancy," said Gilbert Godin, Chief Executive Officer, Duchesnay USA. "The product's safety profile and its proven clinical effectiveness make it a convenient and innovative treatment for women who are seeking effective NVP-symptom relief."
NVP is a medical condition that affects 70 to 85 percent of pregnant women with symptoms ranging from nausea to severe vomiting and retching that can last throughout the day.4,5,6,7 Some pregnant women may experience symptoms throughout their pregnancy.8
The active ingredients included in Diclegis have been recommended as a first-line pharmacotherapy treatment for NVP by the American Congress of Obstetricians and Gynecologists (ACOG) since 2004.2
Pregnant women prescribed Diclegis should take two tablets at bedtime every day. If symptoms are not adequately controlled, the dose can be increased over a period of three days to a maximum recommended dose of four tablets daily – one in the morning, one mid-afternoon and two at bedtime. Diclegis is to be taken as a daily prescription and not on an as needed basis to help control symptoms throughout the day.
Important Safety Information for Diclegis
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 (MAO) inhibitors, as these medicines can intensify and prolong the adverse CNS effects of Diclegis. Use of MAOs may also prolong and intensify the anticholinergic (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 pressure in the eye, (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 at 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 an 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 syndromes may be particularly vulnerable to the sedative effects of Diclegis resulting in worsening of their apnea or 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.
For full prescribing information, please visit www.diclegis.com.
About Nausea and Vomiting of Pregnancy (NVP)
Nausea and vomiting of pregnancy (NVP), or morning sickness, affects 70 to 85 percent of pregnant women.4,5,6,7 NVP can present differently for each woman, the symptoms include: nausea, gagging, retching, dry heaving, vomiting, and odor and/or food aversion.9 For most pregnant women, symptoms generally cease at approximately 16 to 20 weeks.7 However, some women can experience symptoms throughout their pregnancy.8
Diclegis (doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg) delayed-release tablets is the only FDA-approved prescription treatment for nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.1 Diclegis has proven to be a safe and effective treatment option for NVP and received a Pregnancy Category A status, which means the results of controlled studies have not shown an increased risk to an unborn baby.1,3
About Duchesnay USA
Duchesnay USA is a unique healthcare company devoted to safeguarding the health and well-being of expectant mothers and their unborn babies. Its affiliate company, Duchesnay Inc. was founded in 1970 in Canada, the family-owned company realigned its business in 1992 to focus specifically on pregnant women after a family member experienced a very difficult pregnancy. Duchesnay USA was established in Rosemont, Pennsylvania in 2011 to pursue that same mission. Realizing a lack of sufficient information on medications for use in pregnancy, Duchesnay USA strives to ensure that expectant women who require pharmacological treatments have access to proper medical advice and therapies that are safe for them and their unborn babies. Duchesnay USA's mission is to develop pharmacological solutions to reduce the symptoms of nausea and vomiting during pregnancy (NVP). For more information on Duchesnay USA, please visit www.DuchesnayUSA.com.
1 Diclegis Product Label
2 American College of Obstetricians and Gynecologists. Nausea and vomiting of pregnancy. ACOG Practice Bulletin. 2004;52.
3 Department of Health and Human Services, Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Federal Register. 2008; 73 (104):30831-68.
4 Jewell, D, Young, G. Interventions for Nausea and Vomiting in Early Pregnancy. The Cochrane Library.2002; 1
5 Medalie, J. Relationship between Nausea and Vomiting in Early Pregnancy and/or Abortion. The Lancet.1957; 117-119.
6 Whitehead, SA, Andrews, LR, Chamberlain, VP. Characterisation of Nausea and Vomiting in Early Pregnancy: A Survey of 1000 Women. Journal of Obstetrics and Gynaecology.1992; 12: 384-369
7 Gadsby, R, Barnie-Adshead, A, Jagger, C. A Prospective Study of Nausea and Vomiting During Pregnancy. British Journal of General Practice.1993; 43: 245-248.
8 Jarnfelt-Samsioe, A, Samsio, G, Velinder, G. Nausea and Vomiting in Pregnancy – A Contribution to Its Epidemiology. Gynecologic and Obstetric Investigation. 1983; 16: 221-229.
9 Clark S, Costantine M, Hankins GDV. Review of NVP and HG and early pharmacotherapeutic Intervention. Obstetrics and Gynecology International Volume. 2012
SOURCE Duchesnay USA