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Solosec Approved for Bacterial Vaginosis

Symbiomix Therapeutics news release; 2017 Sep 18

The FDA has approved Solosec (secnidazole) oral granules for the treatment of bacterial vaginosis in adult women. The antibiotic is manufactured by Symbiomix Therapeutics, Newark, NJ.

Indication: Solosec is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in adult women and should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Dosage/administration: Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. Sprinkle entire contents onto applesauce, yogurt, or pudding and consume all of the mixture within 30 minutes without chewing or crunching the granules.

Adverse reactions: The most common adverse reactions observed in clinical trials (≥ 2%) were vulvo-vaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.

Citation:

FDA approves Symbiomix Therapeutics’ Solosec (secnidazole) oral granules for the treatment of bacterial vaginosis in adult women. [news release]. Newark, NJ: Symbiomix Therapeutics; September 18, 2017: https://symbiomix.com/fda-approves-symbiomix-therapeutics-solosec-secnid.... Accessed September 19, 2017.