Oteseconazole Dosage

Medically reviewed by Drugs.com. Last updated on Sep 27, 2022.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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