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Sertaconazole: Drug information

Sertaconazole: Drug information
(For additional information see "Sertaconazole: Patient drug information" and see "Sertaconazole: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ertaczo
Pharmacologic Category
  • Antifungal Agent, Imidazole Derivative;
  • Antifungal Agent, Topical
Dosing: Adult
Cutaneous candidiasis

Cutaneous candidiasis (off-label use): Topical: Apply to affected area(s) twice daily for 4 weeks (Alomar 1992).

Seborrheic dermatitis

Seborrheic dermatitis (off-label use): Topical: Apply to affected area(s) twice daily for 4 weeks (Goldust 2013).

Tinea infections

Tinea infections:

Tinea corporis/tinea cruris (off-label use): Topical: Apply to affected and surrounding area(s) 1 to 2 times daily until clinical resolution, typically 1 to 3 weeks (Chatterjee 2016; Goldstein 2022; Sharma 2011; Weinstein 2002).

Tinea pedis (labeled use)/tinea manuum (off-label use): Topical: Apply to affected and surrounding area(s) twice daily until 1 week after clinical resolution, typically for 4 weeks total (Borelli 2007; Goldstein 2022; Weinstein 2002; manufacturer’s labeling).

Tinea versicolor (pityriasis versicolor) (off-label use): Topical: Apply to affected and surrounding area(s) twice daily for 4 weeks (Nasarre 1992).

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Sertaconazole: Pediatric drug information")

Diaper dermatitis, candida

Diaper dermatitis, candida: Limited data available: Infants ≥2 months and Children <2 years: Cream 2%: 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

Tinea corporis: Limited data available: Children ≥2 years and Adolescents: Cream 2%: 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

Tinea pedis: Children ≥12 years and Adolescents: Cream 2%: Topical: Apply between toes and to surrounding healthy skin twice daily for 4 weeks.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

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

Contraindications

There are no contraindications listed in the manufacturer's labeling.

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as nitrate:

Ertaczo: 2% (60 g) [contains methylparaben]

Generic Equivalent Available: US

No

Pricing: US

Cream (Ertaczo External)

2% (per gram): $17.99

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only. Not for oral, ophthalmic, or intravaginal use. Apply to affected and immediately surrounding 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.

Administration: Pediatric

Topical: For external use only. Apply to affected area(s) and surrounding healthy skin. Make sure skin is dry before applying; wash hands after application. Avoid use of occlusive dressing. Avoid contact with eyes, mouth, vagina, and other mucous membranes.

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: Adult

Candidiasis, cutaneous; Seborrheic dermatitis; Tinea corporis/tinea cruris; Tinea manuum; Tinea versicolor (pityriasis versicolor)

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies following oral administration. Systemic absorption following topical application is limited.

Breastfeeding Considerations

It is not known if sertaconazole is present in breast milk.

Systemic absorption following topical application is limited. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Reassess diagnosis if no clinical improvement after 2 weeks.

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Topical: Minimal; serum concentrations below the limit of quantitation (<2.5 ng/mL)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Dermofix;
  • (AR) Argentina: Zalain;
  • (BD) Bangladesh: Fungitac;
  • (BF) Burkina Faso: Dermofix | Zalain;
  • (BG) Bulgaria: Zalain;
  • (BR) Brazil: Gyno zalain | Zalain;
  • (CI) Côte d'Ivoire: Zalain;
  • (CL) Chile: Micoderm | Tromderm | Zalain;
  • (CN) China: Zalain;
  • (CO) Colombia: Gyno zalain | Onabet | Semazin | Xertacol | Zalain;
  • (DE) Germany: Mykosert | Zalain;
  • (DO) Dominican Republic: Dermofix | Zalain;
  • (EC) Ecuador: Zalain;
  • (EG) Egypt: Biosertazol | Dermofix | Velconazole;
  • (ES) Spain: Dermofix | Dermoseptic | Gine zalain | Ginedermofix | Ginezalain | Zalain;
  • (FR) France: Monazol;
  • (HK) Hong Kong: Zalain;
  • (HU) Hungary: Zalain;
  • (ID) Indonesia: Dermofix;
  • (IN) India: Afserta | Fusert | Ibisert | Monoguard | Mycoclin | Onabet | Serbet | Seriva | Sertabor | Sertacream | Sertakon | Sertalin | Sertaset | Sertaspor | Sertazol | Seziom | Skz | Smeto | Sufe | Szhh | Zalain;
  • (IT) Italy: Sertacream | Sertaderm | Sertadie | Sertagyn;
  • (JO) Jordan: Dermofix;
  • (KE) Kenya: Dermofix | Sertakind;
  • (KR) Korea, Republic of: Dermofix | Dermomedi;
  • (KW) Kuwait: Dermofix;
  • (LB) Lebanon: Dermofix;
  • (MA) Morocco: Dermofix;
  • (MX) Mexico: Ertaczo;
  • (MY) Malaysia: Konzert | Zalain;
  • (PE) Peru: Gyno zalain | Zalain;
  • (PH) Philippines: Onabet | Sertaconazole | Zalain;
  • (PK) Pakistan: Dermofix | Sertazol;
  • (PR) Puerto Rico: Ertaczo;
  • (PT) Portugal: Dermofix | Sertopic;
  • (PY) Paraguay: Confornest | Dermofil | Fungarest | Fungoid | Sertaconazol heisecke | Sertaconazol promepar | Zalain;
  • (RU) Russian Federation: Oflomycol | Sertamikol | Sertamycol | Zalain;
  • (SA) Saudi Arabia: Dermofix;
  • (SG) Singapore: Zalain;
  • (TH) Thailand: Zalain;
  • (TR) Turkey: Zalain;
  • (TW) Taiwan: Zalain;
  • (UA) Ukraine: Onabet | Sertaconazole | Sertomax Health | Zalain;
  • (UG) Uganda: Dermofix | Sertacream;
  • (UY) Uruguay: Zalain;
  • (VE) Venezuela, Bolivarian Republic of: Gyno zalain | Onabet | Zalain
  1. Alomar C, Bassas S, Casas M, et al. Multi-centre double-blind trial on the efficacy and safety of sertaconazole 2% cream in comparison with miconazole 2% cream on patients suffering from cutaneous mycoses. Arzneimittelforschung. 1992;42(5A):767-773. [PubMed 1627204]
  2. Bonifaz A, Tirado-Sánchez A, Graniel MJ, Mena C, Valencia A, Ponce-Olivera RM. The efficacy and safety of sertaconazole cream (2 %) in diaper dermatitis candidiasis. Mycopathologia. 2013;175(3-4):249-254. [PubMed 23546772]
  3. Borelli C, Klövekorn G, Ernst TM, Bödeker RH, Korting HC, Neumeister C. Comparative study of 2% sertaconazole solution and cream formulations in patients with tinea corporis, tinea pedis interdigitalis, or a corresponding candidosis. Am J Clin Dermatol. 2007;8(6):371-378. doi:10.2165/00128071-200708060-00007 [PubMed 18039020]
  4. Chatterjee D, Ghosh SK, Sen S, Sarkar S, Hazra A, De R. Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: a randomized, observer-blind, parallel group study. Indian J Pharmacol. 2016;48(6):659-664. doi:10.4103/0253-7613.194850 [PubMed 28066103]
  5. Ertaczo (sertaconazole) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; December 2020.
  6. Goldstein AO, Goldstein BG. Dermatophyte (tinea) infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 7, 2022.
  7. Goldust M, Rezaee E, Masoudnia S, Raghifar R. Clinical study of sertaconazole 2% cream vs. hydrocortisone 1% cream in the treatment of seborrheic dermatitis. Ann Parasitol. 2013;59(3):119-123. [PubMed 24881281]
  8. Nasarre J, Umbert P, Herrero E, et al. Therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of Pityriasis versicolor. Arzneimittelforschung. 1992;42(5A):764-767. [PubMed 1627203]
  9. Sharma A, Saple DG, Surjushe A, et al. Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis. Mycoses. 2011;54(3):217-222. doi:10.1111/j.1439-0507.2009.01801.x [PubMed 19925567]
  10. Van Esso D, Fajo G, Losada I, et al. Sertaconazole in the treatment of pediatric patients with cutaneous dermatophyte infections. Clin Ther. 1995;17(2):264-269. [PubMed 7614526]
  11. Weinstein A, Berman B. Topical treatment of common superficial tinea infections. Am Fam Physician. 2002;65(10):2095-2102. [PubMed 12046779]
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