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Other brands with the same active ingredient
These brands contain the same active ingredient (Oteseconazole). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Otenox 150 is indicated for:
Pharmacology
Oteseconazole is an antifungal medicine. How its effect relates to the dose or level in the body, and how the response changes over time, are not known.
It is an azole metalloenzyme inhibitor and it acts on a fungal sterol enzyme, 14α demethylase (CYP51). This enzyme catalyzes an early step in making ergosterol, a sterol that fungal cell membranes need to form and stay intact. When CYP51 is blocked, 14-methylated sterols build up, and some of these are toxic to fungi. Oteseconazole contains a tetrazole metal-binding group, and because of this it has a lower affinity for human CYP enzymes.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Oteseconazole has two recommended dosage regimens.
For the Oteseconazole-only regimen, give Oteseconazole 600 mg as a single dose on Day 1. On Day 2, give 450 mg as a single dose. Then, beginning on Day 14, give 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12).
For the Fluconazole/Oteseconazole regimen, prescribe fluconazole along with it. Give fluconazole 150 mg orally on Day 1, Day 4 and Day 7. Then give Oteseconazole 150 mg once daily for 7 days, on Days 14 through 20. After that, beginning on Day 28, give Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14).
Oteseconazole should be taken orally with food. Swallow the capsules whole. Do not chew, crush, dissolve or open them.
Side Effects
Headache and nausea are the side effects most often reported with Oteseconazole, each occurring in more than 2% of people.
Cautions & Contraindications
Warnings & Precautions
Embryo-Fetal Toxicity Oteseconazole is contraindicated in females of reproductive potential, and in pregnant and lactating women. Animal studies show that Oteseconazole may cause fetal harm. The drug exposure window is approximately 690 days (based on 5 times the half-life of Oteseconazole), and that is too long to reduce the embryo-fetal toxicity risks adequately. In pre and postnatal developmental studies, pregnant rats were dosed at 7.5 mg/kg/day during organogenesis through lactation, and their offspring had ocular abnormalities. These included cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration and hemorrhage. The abnormalities occurred at doses about 3.5 times the steady state clinical exposure seen in patients treated for RVVC. Patients should be advised that Oteseconazole is contraindicated in females of reproductive potential, and in pregnant and lactating women, because of the potential risks to a fetus or breastfed infant.
Contraindications
Oteseconazole must not be used in females of reproductive potential, in pregnant and lactating women, or in patients who are known to be hypersensitive to oteseconazole.
Pregnancy & Breastfeeding
Oteseconazole must not be used by pregnant women or by females of reproductive potential. Animal studies show it may cause fetal harm when given to a pregnant woman. The drug also stays in the body for about 690 days (this is 5 times its half-life), and that long exposure window means the risk to the embryo and fetus cannot be adequately reduced.
Oteseconazole is also contraindicated in women who are breastfeeding. There are no data on whether oteseconazole passes into human or animal milk, and none on its effect on milk production. No adverse effects were reported in breastfed infants whose mothers were exposed to oteseconazole during lactation. However, the infants were followed up for only a short time after birth, so no conclusions can be drawn from these data.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Otes (oteseconazole) is contraindicated in females of reproductive potential. Animal studies suggest that Otes may cause fetal harm if a pregnant woman takes it, and it may also harm a breastfed infant. Geriatric use: the clinical studies of Otes did not include enough patients aged 65 years and older to show whether they respond differently from younger adults. Renal impairment: no dosage adjustment of Otes is recommended in patients with mild to moderate renal impairment. Hepatic impairment: no dosage adjustment of Otes is recommended in patients with mild hepatic impairment (Child-Pugh A).
Storage
Keep Oteseconazole at a temperature between 20°C and 25°C. Once you take it out of the outer carton, protect it from light. As with all medicines, keep it out of the reach of children.
Common questions about Otenox 150 150 mg
What is Otenox 150 150 mg Capsule?
Otenox 150 150 mg Capsule is a medicine that contains Oteseconazole. It is made by Opsonin Pharma Limited. It belongs to the Other Antifungal preparations group of medicines.
What is Otenox 150 used for?
Otenox 150 is used for: Fungal Infection, Vaginal Candidiasis.
What are the side effects of Otenox 150?
Headache and nausea are the side effects most often reported with Oteseconazole, each occurring in more than 2% of people.
Can I take Otenox 150 during pregnancy or while breastfeeding?
Oteseconazole must not be used by pregnant women or by females of reproductive potential. Animal studies show it may cause fetal harm when given to a pregnant woman. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Otenox 150?
Keep Oteseconazole at a temperature between 20°C and 25°C. Once you take it out of the outer carton, protect it from light.
Do I need a prescription for Otenox 150?
Otenox 150 is a prescription (Rx) medicine. Take it as your doctor advises.