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Other brands with the same active ingredient
These brands contain the same active ingredient (Oteseconazole). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Otenox 150 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
There are two recommended Oteseconazole dosage regimens:For the Oteseconazole-only dosage regimen: On Day 1: Administer Oteseconazole 600 mg (as a single dose), then On Day 2: Administer Oteseconazole 450 mg (as a single dose), then Beginning on Day 14: Administer Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12). For the Fluconazole/Oteseconazole dosage regimen, prescribe Fluconazole and: On Day 1, Day 4, and Day 7: Administer fluconazole 150 mg orally, then On Days 14 through 20: Administer Oteseconazole 150 mg once daily for 7 days, then Beginning on Day 28: Administer Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14). Administer Oteseconazole orally with food. Swallow the capsules whole. Do not chew, crush, dissolve, or open the capsules.
Side Effects
The most frequently reported adverse reactions (incidence >2%) were headache and nausea.
Cautions & Contraindications
Warnings & Precautions
Embryo-Fetal Toxicity: Otenox is contraindicated in females of reproductive potential, and in pregnant and lactating women. Based on animal studies, Otenox may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of Otenox) precludes adequate mitigation of the embryo-fetal toxicity risks. Ocular abnormalities were observed in the offspring of pregnant rats dosed at 7.5-mg/kg/day during organogenesis through lactation in pre and postnatal developmental studies. The observed ocular abnormalities included cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration and hemorrhage. Ocular abnormalities occurred at doses about 3.5 times the steady state clinical exposure seen with patients being treated for RVVC. Advise patients that Otenox is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infan.
Contraindications
Oteseconazole is contraindicated in: Females of reproductive potential Pregnant and lactating women Patients with known hypersensitivity to oteseconazole