Dosing & Uses
Dosage Forms & Strengths
cream
- 2%
Tinea Pedis
Apply BID x 4 weeks; apply enough to cover affected area, & immediately surrounding healthy skin
If no improvement 2 weeks after treatment period, review diagnosis
Other Indications & Uses
Interdigital tinea pedis in immunocompetent patients >12 years old:, caused by Tricophyton rubrum, Tricophyton mentagrophytes, & Epidermophyton floccosum
<12 years old: Safety & efficacy not established
Adverse Effects
Frequency Not Defined
Contact dermatitis
Dry skin
Burning
Erythema
Vesiculation
Desquamation
Hyperpigmentation
Warnings
Contraindications
Hypersensitivity
Not indicated for ophthalmic, oral or intravaginal use
Cautions
Sensitivity to imidazole antifungals (cross-reactivity may occur)
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- In animal reproduction studies, there were no adverse developmental effects observed with oral administration of sertaconazole nitrate to pregnant rats and rabbits during organogenesis at doses 40 and 80 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison
- In rats, when maternal dosing was continued until weaning, a reduction in live birth indices and an increase in the number of still-born pups was observed at doses 20 and 40 times the MRHD based on BSA comparison
Lactation
There are no data available on presence of drug in human or animal milk, its effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Absorption: minimal
Mechanism of Action
Imidazole class of antifungals; believed to inhibit cytochrome P450-dependent synthesis of ergosterol, leading to fungal cell membrane injury through leakage of key constituents
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Ertaczo topical - | 2 % cream | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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