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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: For the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Administration

For external use only. Apply to affected area between toes and to surrounding healthy skin. 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

There are no known significant interactions.

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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