Bonjesta Approved to Treat Nausea and Vomiting of Pregnancy
November 7, 2016 – The US FDA approved Bonjesta (doxylamine/pyridoxine) extended-release tablets; manufactured by Duchesnay, Inc. Bonjesta combines 20mg each of an antihistamine (doxylamine) and a form of vitamin B6 (pyridoxine). It is indicated to treat nausea and vomiting associated with pregnancy when conservative treatment, such as dietary modification, is not effective. If the recommended dose of one tablet at bedtime does not control symptoms, an additional tablet may be added in the morning. No more than two tablets should be taken per day and they should be swallowed whole with a full glass of water but no food. Bonjesta may cause sleepiness. It has not been tested among patients who are under the age of 18 years or who have hyperemesis gravidarum, a serious condition that may need hospitalization. Duchesnay also manufactures Diclegis® (doxylamine/pyridoxine) delayed-release tablets, which was FDA approved in April 2013. Also indicated for pregnancy-related nausea and vomiting, Diclegis contains 10mg of each ingredient in Bonjesta.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.