Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as nitrate:
Ertaczo: 2% (60 g) [contains methylparaben]
Pharmacology
Mechanism of Action
Alters fungal cell wall membrane permeability; inhibits the CYP450-dependent synthesis of ergosterol
Pharmacokinetics/Pharmacodynamics
Absorption
Topical: Minimal; serum concentrations below the limit of quantitation (<2.5 ng/mL)
Use: Labeled Indications
Tinea pedis: Topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Use: Off Label
Cutaneous candidiasisb
Data from a randomized, double blind study supports the use of sertaconazole for the treatment of cutaneous candidiasis Alomar 1992. Additional trials may be necessary to further define the role of sertaconazole in this condition.
Seborrheic dermatitisb
Data from a randomized, double blind study supports the use of sertaconazole in the treatment of seborrheic dermatitis Goldust 2013. Additional trials may be necessary to further define the role of sertaconazole in this condition.
Tinea versicolorc
Data from a limited number of patients studied suggest that sertaconazole may be beneficial for the treatment of tinea versicolor Nasarre 1992. Additional data may be necessary to further define the role of sertaconazole in this condition.
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Dosing: Adult
Tinea pedis: Topical: Apply between toes and to surrounding healthy skin twice daily for 4 weeks
Cutaneous candidiasis (off-label use): Topical: Apply to affected area(s) twice daily for 4 weeks (Alomar 1992)
Seborrheic dermatitis (off-label use): Topical: Apply to affected area(s) twice daily for 4 weeks (Goldust 2013)
Tinea versicolor (off-label use): Topical: Apply to affected area(s) twice daily for 4 weeks (Nasarre 1992). Additional data may be necessary to further define the role of sertaconazole in this condition.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Diaper dermatitis, candida: Limited data available: Infants and Children 2 to 24 months: Topical: Apply twice daily for 2 weeks; dosing based on an open-label, noncomparative study (n=27, mean age: 5.7 months, range: 2 to 22 months), 88.8% had complete cure; one patient had increased erythema but continued treatment (Bonifaz, 2013.)
Tinea corporis: Limited data available: Children ≥2 years and Adolescents: Topical: Apply once daily for 2 weeks; dosing based on an open-label study (n=16 patients age: 2 to 16 years, including 14 patients with tinea corporis); clinical cure was achieved in 75% of patients at 2 weeks and 100% of patients at 4 weeks (2 weeks post therapy follow-up assessment); no adverse effects were reported (Van Esso, 1995)
Tinea pedis: Children ≥12 years and Adolescents: Topical: Apply between toes and to surrounding healthy skin twice daily for 4 weeks
Administration
For external use only. Not for oral, ophthalmic, or intravaginal use. Apply to affected area(s) as directed. Make sure skin is dry before applying; wash hands after application. Avoid use of occlusive dressing. Avoid contact with eyes, nose, mouth, and other mucous membranes.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
Drug Interactions
Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination
Adverse Reactions
1% to 10%: Dermatologic: Burning sensation of skin, contact dermatitis, skin tenderness, xeroderma
<1%, postmarketing and/or case reports: Desquamation, erythema, hyperpigmentation, pruritus, skin vesicle
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: Discontinue drug if sensitivity or irritation occurs.
Other warnings/precautions:
- Appropriate use: For topical use only; avoid ophthalmologic, oral, or intravaginal use. Re-evaluate use if no response within 2 weeks.
Monitoring Parameters
Reassess diagnosis if no clinical improvement after 2 weeks.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies following oral administration.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dry skin. Have patient report immediately to prescriber persistent fungal infection, skin discoloration, burning, or severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
