Indication

SOLOSEC^® (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older and trichomoniasis in patients 12 years of age and older. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.

Dosage and Administration

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. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy.

Important Safety Information

• SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives and in patients with Cockayne syndrome.
• Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
• Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
• Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
• Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
• In patients with Cockayne syndrome, after initiation of systemic use of metronidazole, another nitroimidazole agent, cases of severe irreversible hepatotoxicity/acute liver failure (including cases of fatal outcomes) have been reported.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732).

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