Solosec™
Drug - Solosec™ (secnidazole) [Lupin Pharma]
July 2018
Therapeutic Area - Bacterial vaginosis
Approval criteria
- Patients must be over 18 years of age AND
- Patient must have a clinical diagnosis bacterial vaginosis based on ALL of the following:
- off-white/gray vaginal discharge
- vaginal pH ≥ 4.7
- clue cells ≥ 20% on microscopy
- positive 10% KOH whiff test
- Nugent score ≥ 4 on gram stain
AND
- Patient must not have prior failure of metronidazole or tinidazole for the current course of infection AND
- Prescriber must provide rationale as to why oral/topical metronidazole, oral/topical clindamycin, and oral tinidazole cannot be used
Quantity limits
Background
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 bacteria.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
