Sertaconazole Nitrate

ERTACZO® (sertaconazole nitrate) cream, 2%, is indicated 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 [see Clinical Studies].

Do not use sertaconazole topical without first talking to your doctor if you have had an allergic reaction to it in the past.

Sertaconazole topical is in the FDA pregnancy category C. This means that it is not known whether sertaconazole topical will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether sertaconazole passes into breast milk. Do not use sertaconazole topical without first talking to your doctor if you are breast-feeding a baby.

Antifungal; azole (imidazole derivative).1

Dermatophytoses

Treatment of interdigital tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum in immunocompetent adults and children ≥12 years of age.1 2 16

Topical antifungals usually effective for treatment of uncomplicated tinea pedis;13 25 an oral antifungal usually necessary for treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for treatment of tinea unguium (onychomycosis).13 23 25

Treatment of tinea corporis† (ringworm of the body),16 tinea cruris† (jock itch),16 or tinea manuum† (hand ringworm)16 caused by E. floccosum, Microsporum (including M. canis), or Trichophyton (including T. mentagrophytes, T. rubrum, and T. schonleinii).16 19

Topical antifungals usually effective for uncomplicated tinea corporis, tinea cruris, and tinea manuum; an oral antifungal usually necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.13 20 23 25

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor† caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).17 19

Topical treatment usually effective; an oral antifungal (alone or in conjunction with a topical agent) may be necessary in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.21 22 23

Cutaneous Candidiasis

Treatment of superficial cutaneous candidiasis caused by Candida albicans†.18 19

Administration

Topical Administration

Apply topically to the skin as a 2% cream.1

Do not apply to the eye or administer orally or intravaginally.1

Avoid contact with the nose, mouth, and other mucous membranes.1 19 20 21

Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.1

Apply a sufficient amount of cream twice daily; rub gently into affected area (e.g., between the toes) and immediately surrounding healthy skin.1

Dosage

Available as sertaconazole nitrate; dosage expressed in terms of sertaconazole nitrate.1

Pediatric Patients

Children ≥12 years of age: Apply twice daily for 4 weeks.1

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.1

Adults

Apply twice daily for 4 weeks.1

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.1

Has been applied twice daily for 4 weeks.16 17

Has been applied twice daily for 4 weeks.17

Has been applied twice daily for 4 weeks.18

Contraindications

• Known hypersensitivity to sertaconazole, other imidazoles, or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Contact dermatitis reported rarely following topical application.1 5

If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.1 5

Possible cross-sensitization among the imidazoles.1 5

General Precautions

Prior to initiation of therapy, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.1

Specific Populations

Category C.1

Not known whether distributed into milk following topical application of 2% cream.1 Use with caution.1

Safety and efficacy not established in children <12 years of age.1

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Contact dermatitis, dry skin, burning skin, application site reaction, skin tenderness.1

• Imidazole-derivative azole antifungal.1 10 11

• Usually fungistatic; may be fungicidal at high concentrations.6 12

• Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition.1 6 11

• Fungistatic activity may result from interference with ergosterol synthesis.1 6 8 10 11 12 Fungicidal activity at high concentrations may result from a direct physiochemical effect on the fungal cell membrane.6 8 12

• Spectrum of antifungal activity includes many fungi, including dermatophytes and yeasts.1 3 4 6 8 10 14 15 Also has in vitro activity against some gram-positive bacteria.4

• Dermatophytes: Active in vitro against Epidermophyton floccosum,1 7 8 9 14 Microsporum audouini,7 8 9 14 M. canis,7 8 9 14 15 M. gypseum,7 8 9 14 15 M. racemosum,9 Trichophyton erinacei,9 T. interdigitale,7 9 14 T. mentagrophytes,1 7 8 9 14 15 T. rubrum,1 7 8 9 14 15 T. schoenleinii,7 9 T. soudanese,9 T. terreste,9 T. tonsurans,7 9 T. verrucosum,7 and T. violaceum.7 9

• Also active in vitro against Malassezia furfur (Pityrosporum orbiculare or P. ovale).10 14

• Candida: Active in vitro against C. albicans,4 6 8 14 15 C. beigelii,6 14 C. dubliniensis,4 C. famata,8 C. glabrata (formerly Torulopsis glabrata),4 6 7 8 14 C. guilliermondii,4 6 7 8 C. holmii,4 C. humicola,4 7 8 C. inconspicua,4 C. intermedia,4 8 C. krusei,4 6 8 14 15 C. lambica, 4 C. lipolytica,4 C. lusitaniae,4 6 C. parapsilosis,4 6 8 15 C. pulcherrima,4 C. pseudotropicalis,6 14 15 C. rugosa,4 and C. tropicalis.4 6 8 14 15

• Although clinical importance unknown, T. mentagrophytes, T. rubrum, and M. canis clinical isolates with in vitro resistance to sertaconazole reported.9 Some of these also were resistant to other imidazoles (e.g., clotrimazole, fluconazole, ketoconazole, miconazole, tioconazole).9

• C. albicans serotype B vaginal isolate with in vitro resistance to sertaconazole and other imidazoles (e.g., econazole, fluconazole, itraconazole, ketoconazole miconazole) reported.4

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.