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Sertaconazole

Pronunciation

(ser ta KOE na zole)

Index Terms

  • Sertaconazole Nitrate

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]

Brand Names: U.S.

  • Ertaczo

Pharmacologic Category

  • Antifungal Agent, Imidazole Derivative
  • Antifungal Agent, Topical

Pharmacology

Alters fungal cell wall membrane permeability; inhibits the CYP450-dependent synthesis of ergosterol

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.

Off Label Uses

Cutaneous candidiasis

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 dermatitis

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 versicolor

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.

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

Tinea pedis: Topical: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

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% (Limited to important or life-threatening): 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 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 yeast 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.

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