Drug Detail:Oteseconazole (Oteseconazole [ oh-tes-e-kon-a-zole ])
Drug Class: Azole antifungals
Usual Adult Dose for Vaginal Candidiasis
There are 2 recommended dosage regimens, and only one should be used:
Oteseconazole-Only Dosage Regimen:
- Day 1: 600 mg orally as a single dose
- Day 2: 450 mg orally as a single dose
- Beginning on Day 14: 150 mg orally once a week (every 7 days) for 11 weeks (weeks 2 through 12)
- Duration of therapy: 12 weeks
Oteseconazole and Fluconazole Dosage Regimen:
- Day 1, Day 4 and Day 7: Administer Fluconazole orally (should be prescribed separately)
- Day 14 to 20: Administer Oteseconazole 150 mg orally once a day for 7 days
- Beginning of Day 28: Administer Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (weeks 4 to 14)
- Duration of therapy: 14 weeks
Use: Recurrent Vulvovaginal Candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential
Renal Dose Adjustments
Mild and Moderate Renal Dysfunction: No adjustment recommended.
Severe Renal Dysfunction: Not recommended.
Liver Dose Adjustments
Mild Liver Dysfunction: No adjustment recommended.
Moderate and Severe Liver Dysfunction (Child-Pugh B and C): Not recommended.
Precautions
US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides
CONTRAINDICATIONS:
- Known hypersensitivity to the active component or any of the ingredients
- Females of reproductive potential
- Pregnant and Lactating women
Safety and efficacy have not been established in pre-menarchal patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Not recommended.
Other Comments
Administration advice:
- If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before results are known and should be adjusted accordingly once the results become available.
- Administer orally with food.
- Swallow the capsule whole. Do not chew, crush, dissolve, or open the capsules.
Storage requirements:
- Store at 20C to 25C (68F to 77F); with excursions permitted between 15C and 30C (59F to 86F).
- Protect from light once removed from the outer carton.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- This drug is contraindicated during pregnancy and lactation and in women of reproductive potential.
- Tell your healthcare provider all the other drugs that you are taking. Some drugs may increase the risk of adverse reactions associated with this drug.
