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Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that has been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for bacteria vaginosis the most common gynecologic infection. Bacteria vaginosis has been shown to increase the cause of chlamydia, gonorrhea, herpes, trichomaniasis and HIV, pre-term birth and low birth weight if left untreated.
A single dose regimen may improve adherence and the likelihood of a successful cure. No serious adverse events were reported during the trial and no patients discontinued treatment due to adverse events. Solosec is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.
Vulvo-vaginal candidiasis may develop with Solosec and require treatment with an antifungal agent. Potential risk of carcinogenicity in patients taking single-dose of Solosec to treat bacterial vaginosis is unclear. Chronic use should be avoided. Solosec may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of Solosec.
Solosec is a single-dose therapy for oral use. The entire contents of Solosec packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. Solosec is not intended to be dissolved in any liquid. In clinical studies, the most common adverse effects of the drug are headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain and vulvovaginal pruritus.
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