Duchesnay USA Granted Kosher and Halal Certification for Diclegis® (doxylamine succinate and pyridoxine hydrochloride), the Only FDA-Approved Treatment for Nausea and Vomiting of Pregnancy (NVP)
ROSEMONT, Pa., March 27, 2014 /PRNewswire/ — Duchesnay USA is pleased to announce Kosher and Halal certifications for Diclegis(®) (doxylamine succinate 10mg and pyridoxine hydrochloride -vitamin B(6)- 10mg) delayed-release tablets, the only FDA-approved prescription treatment for nausea and vomiting of pregnancy (NVP), more commonly known as morning sickness. Diclegis also received Kosher for Passover certification and confirmed as gluten, lactose and tartrazine free, making the product accessible for women suffering from celiac disease or gluten and lactose intolerance.()
“Duchesnay USA’s ultimate goal is to provide access to safe and effective treatments to pregnant women. This includes meeting the specific needs of pregnant women of all cultural and religious backgrounds as well as those that may have dietary restrictions,” said Eric Gervais, Executive Vice President of Duchesnay Inc.
Duchesnay USA received its Kosher and Passover certification from the Kashruth Council of Canada (COR): Kosher Certification Agency and Halal certification from the Islamic Society of North America (ISNA®) Halal Certification Agency. These certifications, which were granted by well recognized and independent organizations, determine whether products are being manufactured according to specific high standards of preparation and selection of ingredients.
For more information about Diclegis®, visit www.Diclegis.com.
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.
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.( ) 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.
About Duchesnay USA
Duchesnay USA is a unique research-based 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. For more information on Duchesnay USA, please visit www.DuchesnayUSA.com.
() Duchesnay USA, Inc. – Data on File.
SOURCE Duchesnay USA