Vulcan 150 mg

Vulcan 150 mg | INDICATIONS AND USES

Oteseconazole is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Vulcan 150 mg | PHARMACOLOGY

Oteseconazole is an antifungal drug. Oteseconazole exposure-response relationships and the time course of pharmacodynamic response are unknown. Oteseconazole is an azole metalloenzyme inhibitor targeting the fungal sterol, 14α demethylase (CYP51), an enzyme that catalyzes an early step in the biosynthetic pathway of ergosterol, a sterol required for fungal cell membrane formation and integrity. Inhibition of CYP51 results in the accumulation of 14-methylated sterols, some of which are toxic to fungi. Through the inclusion of a tetrazole metal-binding group, oteseconazole has a lower affinity for human CYP enzymes.

Vulcan 150 mg | DOSAGE & ADMINISTRATION

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.

Vulcan 150 mg | DRUG INTERACTIONS

BCRP (Breast Cancer Resistance Protein) Substrates: Concomitant use of Oteseconazole with BCRP substrates may increase the exposure of drugs that are BCRP substrates, which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drugs and monitor for adverse reactions.

Vulcan 150 mg | SIDE EFFECTS

The most frequently reported adverse reactions (incidence >2%) were headache and nausea.

Vulcan 150 mg | USE DURING PREGNANCY AND LACTATION

Oteseconazole is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, Oteseconazole may cause fetal harm when administered to pregnant women. In addition, the drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks.Oteseconazole is contraindicated in lactating women and females of reproductive potential. There are nodata on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation; however, given the limited duration of follow-up of the oteseconazole-exposed infants during the post-natal period, no conclusions can be drawn from these data

Vulcan 150 mg | PRECAUTIONS & WARNINGS

Embryo-Fetal Toxicity: Oteseconazole is contraindicated in females of reproductive potential, and in pregnant and lactating women. Based on animal studies, Oteseconazole may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) 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 Oteseconazole is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infan.

Vulcan 150 mg | USE IN SPECIAL POPULATIONS

Pediatric Use: Oteseconazole is contraindicated in females of reproductive potential. Based on animal studies, Oteseconazole may cause fetal harm when administered to a pregnant woman or potential harm to the breastfed infant. Geriatric Use: Clinical studies of Oteseconazole did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.Renal Impairment: No dosage adjustment of Oteseconazole is recommended in patients with mild to moderate renal impairment.Hepatic Impairment: No dosage adjustment of Oteseconazole is recommended in patients with mild hepatic impairment (ChildPugh A).

Vulcan 150 mg | THERAPEUTIC CLASS

Other Antifungal preparations

Vulcan 150 mg | STORAGE CONDITIONS

Store at 20°C to 25°C. Protect from light when removed from the outer carton. Keep the medicine out of the reach of children.