Otezol Capsule
Oteseconazole
150mg
Eskayef Pharmaceuticals Ltd.
| Pack size | 12's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 200.00 AED |
Indications
Otezol Capsule is used for:
Vulvovaginal Candidiasis
Adult Dose
Oral
Capsule
Vulvovaginal Candidiasis
Indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential
Oteseconazole-only regimen
Day 1: 600 mg PO x 1 dose, THEN
Day 2: 450 mg PO x 1 dose, THEN
Beginning on Day 14: 150 mg PO once weekly for 11 weeks (Weeks 2 through 12)
Fluconazole/Oteseconazole dosage regimen-
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).
Hepatic impairment
Mild-to-moderate (Child-Pugh A or B): No dosage adjustment is necessary
Severe (Child-Pugh C): Not studied
Child Dose
Renal Dose
Renal impairment
Mild-to-severe (eGFR 15-89 mL/min): No dosage adjustment is necessary
End-stage renal disease (eGFR <15 mL/min): Effect on pharmacokinetics unknown
Dialysis: Not expected to alter systemic exposure
Administration
Administer with food
Contra Indications
Females of reproductive potential
Pregnant and lactating females
Hypersensitivity to oteseconazole
Precautions
Based on animal studies, fetal harm may occur.
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 infant.
Pregnancy-Lactation
Pregnancy
Contraindicated in females of reproductive potential and in pregnant females
Drug exposure window is ~690 days (based on 5x the half-life of oteseconazole) to prevent any risks of embryofetal toxicities
Animal data
Ocular abnormalities (eg, cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration, hemorrhage) observed in rat offspring from Gestation Day 6 through Lactation Day 20 at doses 3.5x the recommended human dose
Data are insufficient to exclude any potential risk of cataracts or other eye abnormalities in human infants
Lactation
Contraindicated in lactating females
There are no data on the presence of oteseconazole in human or animal milk or its effects on milk production
There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation
Owing to the limited duration of follow-up of oteseconazole-exposed infants during the postnatal period, no conclusions can be drawn from the data
Interactions
Inhibitor of breast cancer resistance protein (BCRP)
BCRP substrates
Use lowest possible starting dose of BCRP substrate, or consider reducing BCRP substrate dose; monitor adverse reactions
Oteseconazole may increase effects and toxicities of BCRP substrates
Adverse Effects
Side effects of Oteseconazole :
Nausea (3.6%)
Dyspepsia (<2%)
Hot flush (<2%)
Dysuria (<2%)
Menorrhagia (eg, genital hemorrhage, menorrhagia, menometrorrhagia, uterine hemorrhage, vaginal hemorrhage) (<2%)
Metrorrhagia (<2%)
Vulvovaginal irritation (eg, vulvovaginal burning sensation, vulvovaginal discomfort, vulvovaginal pain) (<2%)
Elevated serum creatine phosphokinase ≥10x ULN (1.9%)
<1%
Allergic dermatitis (<0.2%)
Mechanism of Action
Azole metalloenzyme inhibitor targets fungal sterol 14-alpha demethylase (CYP51) Inhibition of CYP51 results in accumulation of 14-methylated sterols, which may be toxic to fungi.
Note
Otezol 150mg Capsule manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Oteseconazole. Otezol is availble in Bangladesh.
Farmaco BD drug index information on Otezol Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.