Overview of Diclegis FDA Approval Information
The FDA approved Diclegis, a combination of doxylamine succinate and pyridoxine hydrochloride, in 2013; It is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Diclegis is now the only FDA-approved prescription medicine for this condition and provides relief when diet and lifestyle changes are ineffective. The most common side effect of Diclegis is drowsiness. The medication underwent extensive clinical trials before receiving FDA approval.
Diclegis FDA Approval History
In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of nausea and vomiting of pregnancy (NVP). Diclegis is currently the only medication that is FDA-approved for the indication of NVP;
Indications and Usage
Diclegis is a delayed-release tablet containing a combination of doxylamine, an antihistamine, and pyridoxine, a form of vitamin B6. This medication is specifically indicated for the treatment of nausea and vomiting of pregnancy (NVP) when conservative management methods, such as dietary and lifestyle changes, do not provide relief. Pregnant women can consider Diclegis as an option to alleviate these symptoms. Always consult with a healthcare provider before starting any new medication.
Composition and Dosage
Diclegis is a delayed-release tablet that combines doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a form of vitamin B6. Each tablet contains 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. The recommended dosage typically involves taking one tablet at bedtime, and if necessary, one additional tablet in the morning. It is crucial to follow the dosage instructions provided by a healthcare professional to ensure proper usage and effectiveness of the medication.
Study Participants and Clinical Trials
Diclegis underwent clinical trials with study participants who were pregnant women experiencing nausea and vomiting of pregnancy (NVP). These participants were between seven and fourteen weeks pregnant. The trials aimed to assess the effectiveness and safety of Diclegis in providing relief from NVP symptoms when conservative management methods were not effective. The FDA approval of Diclegis was based on the results of these trials.
Safety Information and Side Effects
When taking Diclegis, it’s important to be aware of potential side effects, with drowsiness being the most common. If you experience any unusual or severe side effects while using Diclegis, it is essential to contact your healthcare provider promptly. It’s advisable not to operate heavy machinery or drive until you know how Diclegis affects you. Always follow the safety guidelines provided by your healthcare professional to ensure the proper and safe use of Diclegis.
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