Indication:
Vulcan is prescribed to reduce the recurrence of vulvovaginal candidiasis (RVVC) in women with a history of RVVC who are not of reproductive potential. Antifungal therapy should be adjusted based on fungal culture results.
Pharmacology:
- Active Ingredient: Oteseconazole
- Mechanism: Oteseconazole inhibits the 14α-demethylase enzyme, which is essential for fungal sterol biosynthesis. This disruption leads to toxic sterols accumulating in fungi, affecting cell membrane integrity. Oteseconazole has a low affinity for human enzymes.
Dosage & Administration:
- Oteseconazole-Only Regimen:
- Day 1: 600 mg
- Day 2: 450 mg
- Days 14-24: 150 mg weekly for 11 weeks
- Fluconazole/Oteseconazole Regimen:
- Days 1, 4, 7: 150 mg Fluconazole
- Days 14-20: 150 mg Oteseconazole daily
- Days 28-38: 150 mg Oteseconazole weekly for 11 weeks
- Administration: Take with food; swallow capsules whole—do not chew, crush, or open.
Interactions:
- BCRP Substrates: May increase the risk of adverse reactions. Consider dose adjustments and monitor closely.
Contraindications:
- Females of reproductive potential
- Pregnant and lactating women
- Individuals with known hypersensitivity to oteseconazole
Side Effects:
- Common reactions include headache and nausea.
Pregnancy & Lactation:
- Pregnancy: Contraindicated due to potential fetal harm.
- Lactation: Contraindicated; insufficient data on transfer to breast milk or effects on infants.
Precautions & Warnings:
- Avoid use in reproductive-age women, during pregnancy, and lactation due to significant risks.
- Monitor for potential fetal harm and ocular abnormalities observed in animal studies.
Special Populations:
- Pediatric Use: Not recommended.
- Geriatric Use: Limited data; no significant differences observed.
- Renal Impairment: No dosage adjustment for mild to moderate impairment.
- Hepatic Impairment: No adjustment needed for mild hepatic impairment.
Storage Conditions:
- Store at 20°C to 25°C.
- Protect from light.
- Keep out of reach of children.
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