Otegal^TM

Indication:
Otegal^TM Capsule is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential.

Dosage & Administration:
There are two recommended dosage regimens: An Oteseconazole only regimen and a Fluconazole/Oteseconazole regimen. Use one of these two dosage regimens. Administer orally with food.
For the Oteseconazole-only Dosage Regimen:
• On Day 1: Administer 150 mg 4 capsules 600 mg (as a single dose), then
• On Day 2: Administer 150 mg 3 capsules 450 mg (as a single dose), then
• Beginning on Day 14: Administer 150 mg 1 capsule once a week (every 7 days) for 11 weeks (Weeks 2 through 12).
For the Fluconazole/ Oteseconazole Dosage Regimen:
• On Day 1, Day 4, and Day 7: Administer Fluconazole 150 mg 1 capsule orally, then
• On Days 14 through 20: Administer 150 mg 1 capsule once daily for 7 days, then
• Beginning on Day 28: Administer 150 mg 1 capsule once a week (every 7 days) for 11 weeks (Weeks 4 through 14)

Preparation:
Otegal^TM Capsule: Each box containing 10 capsules in Alu-Alu blister pack.