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FDA Approves Duchesnay USA's Diclegis® For Treatment Of Nausea And Vomiting Of Pregnancy (NVP)

The New Drug Application submission with the FDA was based on a 15-day double-blind, randomized, multi-center placebo-controlled trial studying pregnant women 18 years of age or older, 7 to 14 weeks gestation, with NVP. Use of Diclegis resulted in significantly larger improvement in symptoms of NVP compared with placebo, based on the PUQE score. This study concluded that Diclegis delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating NVP. i

Diclegis Dosage and Administration

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 in women who do not respond to conservative management. i

Initially, a patient takes two Diclegis delayed-release tablets orally at bedtime (Day 1).  If symptoms persist into the afternoon of Day 2, the patient takes the usual dose of two tablets at bedtime that night and then adds one tablet the following morning on Day 3. If symptoms still persist on Day 4, the patient takes one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime. The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily. Diclegis is taken as a daily prescription and not on an as needed basis to help control symptoms throughout the day. i

Important Safety Information for Diclegis

Indication 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.

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