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On February 17, 2022 Lupin announced about the U.S. FDA approval of their supplemental New Dug Application (sNDA) to expand the use of SOLOSEC (secnidazole) in the treatment of bacterial vaginosis (BV) for female patients and trichomoniasis for all patients 12 years of age and older.
Details of SOLOSEC:
- SOLOSEC is a single-dose oral antibiotic that provides complete course therapy for Bacterial vaginosis and Trichomoniasis in patients 12 years of age or older.
- SOLOSEC- It contains secnidazole, an antimicrobial agent
- Dose- A single dose packet contains 2g oral granules
- Signatura- SOLOSEC granules should be sprinkle onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules.
- For the treatment of bacterial vaginosis in female patients 1 years of age and older the recommended dose is a single 2-gram packet taken orally, without regard to the timing of meals.
- For the treatment of Trichomoniasis in female patients 1 years of age and older the recommended dose is a single 2-gram packet taken orally, without regard to the timing of meals. As this is a sexually transmitted disease, treat sexual partners with the same dose at the same time to avoid reinfection.
- Avoid alcoholic beverages and preparation containing ethanol or propylene glycol during treatment at least 2 days after completing therapy.
Contraindications-
- SOLOSEC is contraindicated to the patients who have history of hypersensitivity to secnidazole or other nitroimidazole derivatives and patients with Cockayne syndrome.
- Vulvovaginal candidiasis may develop and additional antifungal treatment may required.
- Breast feeding is not recommended. Patient should discontinue breastfeeding for 96 hours after SOLOSEC administration.
- Potential risk of carcinogenicity has not been studied in patients, but has been shown in rodents when chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole.
- Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhoea, 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.
“The FDA’s approval expands the indication for SOLOSEC® to treat adolescents and builds upon our commitment to support women’s health. This expansion brings to health care professionals a treatment option for both BV and Trichomoniasis in Adolescents which provides a complete course of therapy in a single dose, one which helps to address gaps in care related to adherence5, and may reduce risk factors associated with BV and trichomoniasis6-7, such as other sexually transmitted diseases (STIs)8-9,” said Tom Merriam, Executive Director – Specialty, Lupin. “We are optimistic about this new treatment option for both healthcare practitioners and their adolescent patients.”
To know more click here- hhttp://www.SOLOSEC.comere
