Solosec (Secnidazole) 2 gram Oral Granules for Bacterial Vaginosis Treatment
Solosec (Secnidazole) 2 gram Oral Granules for Bacterial Vaginosis Treatment. SOLOSEC is indicated for the treatment of bacterial vaginosis in adult women.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The recommended dosage of SOLOSEC is a single 2-gram packet of granules taken once orally, without regard to the timing of meals.
Instructions for the Preparation and Administration of SOLOSEC
•Open the SOLOSEC packet by folding over the corner (marked by an arrow) and tearing across the top.
•Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the mixture within 30 minutes without chewing or crunching the granules. A glass of water may be taken after the administration of SOLOSEC to aid in swallowing.
•The granules are not intended to be dissolved in any liquid.
Oral Granules: 2 g, of off-white to slightly yellowish granules with 4.8 g net weight, packed in a unit-of-use child-resistant foil packet.
WARNINGS AND PRECAUTIONS
The use of SOLOSEC may result in vulvo-vaginal candidiasis. In controlled clinical trials of non-pregnant women with bacterial vaginosis, vulvo-vaginal candidiasis developed in 19/197 (9.6%) of subjects who received 2 g SOLOSEC and 4/136 (2.9%) subjects who received placebo. Symptomatic vulvo-vaginal candidiasis may require treatment with an antifungal agent.
Potential Risk for Carcinogenicity
Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives which are structurally related to secnidazole. It is unclear if the positive tumor findings in lifetime rodent studies of these nitroimidazoles indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis. Avoid chronic use of SOLOSEC.
Prescribing SOLOSEC in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.