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Sertaconazole: Drug information

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

For abbreviations, symbols, and age group definitions 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 (Ref).

Seborrheic dermatitis

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

Tinea infection

Tinea infection:

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 (Ref).

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 (Ref).

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

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: Liver 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 (Ref).

Tinea corporis

Tinea corporis (ringworm): Limited data available: Children ≥2 years and Adolescents: Cream 2%: Topical: Apply 1 to 2 times daily to affected and surrounding area(s) until clinical resolution, typically 2 to 4 weeks (Ref).

Tinea cruris

Tinea cruris (jock itch): Limited data available: Children ≥2 years and Adolescents: Cream 2%: Topical: Apply 1 to 2 times daily to affected and surrounding area(s) until clinical resolution, typically 2 to 4 weeks (Ref).

Tinea pedis

Tinea pedis (athlete's foot): Children ≥2 years and Adolescents: Limited data available in ages <12 years: Cream 2%: Topical: Apply twice daily to affected and surrounding area(s) until clinical resolution, typically 4 weeks (Ref).

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: Liver 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: Erythematous condition (4%)

Postmarketing: Dermatologic: Desquamation, 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: Cream: For external use only. Apply to affected area(s) and surrounding healthy skin (for tinea, ~1 to 2 cm beyond lesion border (Ref)). 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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may decrease therapeutic effects of Progesterone. Risk X: Avoid

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: Ertaco | Fungitac | Mycofast | Sertacon;
  • (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: Kimadex | Semazin | Zalain;
  • (EE) Estonia: Cagynol;
  • (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 | Iz s | Monoguard | Mycoclin | Onabet | Serbet | Seriva | Sernova | Sertabor | Sertacream | Sertakon | Sertalin | Sertaset | Sertaspor | Sertavib | 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;
  • (LT) Lithuania: Cagynol;
  • (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: Flucovag | Oflomycol | Sertamikol | Sertamycol | Zalain;
  • (SA) Saudi Arabia: Dermofix;
  • (SG) Singapore: Zalain;
  • (TH) Thailand: Zalain;
  • (TR) Turkey: Zalain;
  • (TW) Taiwan: Zalain;
  • (UA) Ukraine: Candiclin | Onabet | Sertaconazole | Sertomax Health | Zalain;
  • (UG) Uganda: Dermofix | Sertacream | Sertakind;
  • (UY) Uruguay: Zalain;
  • (VE) Venezuela, Bolivarian Republic of: Gyno zalain | Onabet | Zalain
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