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Sertaconazole

Medically reviewed by Drugs.com. Last updated on Sep 12, 2020.

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

Diaper dermatitis, candida: Limited data available: Infants ≥2 months and Children <2 years: Topical: Apply twice daily after a diaper change 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; 1 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; ages: 2 to 16 years; 14 patients with tinea corporis); clinical cure was achieved in 75% of patients at 2 weeks and 100% of patients at 4 weeks (2-week post-therapy completion 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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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 Risk Factor

C

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies following oral administration.

Patient Education

What is this drug used for?

• It is used to treat fungal infections of the skin.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Persistent fungal infection

• Skin discoloration

• Burning

• Severe skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.