×
Components:
Sertaconazole
Method of action:
Antifungal Broad Spectrum
Available in countries
See all
close
Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.06

Name of the medicinal product

Konzert

Qualitative and quantitative composition

Sertaconazole

Therapeutic indications

The information provided in Therapeutic indications of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

Konzert® (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.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

In the treatment of interdigital tinea pedis, Konzert cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Konzert cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis.

Not for ophthalmic, oral, or intravaginal use.

Contraindications

The information provided in Contraindications of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

None.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Adverse Reactions

If irritation develops, treatment should be discontinued and appropriate therapy instituted.

Physicians should exercise caution when prescribing Konzert cream, 2%, to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.

Patient Counseling Information

See FDA-approved Patient Labeling (PATIENT INFORMATION)

The patient should be instructed to:

  • Use Konzert cream, 2%, as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, mouth, vagina and other mucous membranes. Konzert cream, 2%, is for external use only.
  • Dry the affected area(s) thoroughly before application, if you wish to use Konzert cream, 2%, after bathing.
  • Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved.
  • Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling or oozing.
  • Avoid the use of occlusive dressings unless otherwise directed by the physician.
  • Do not use this medication for any disorder other than that for which it was prescribed.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).

No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.

At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies conducted with Konzert cream in pregnant women. Konzert cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Reproduction studies have not been performed with Konzert cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day sertaconazole nitrate in an oral peri-and post-natal development study in rats.

Nursing Mothers

It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing Konzert cream, 2%, to a nursing woman.

Pediatric Use

The efficacy and safety of Konzert cream, 2%, have not been established in pediatric patients below the age of 12 years.

Geriatric Use

Clinical trials of Konzert cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Undesirable effects

The information provided in Undesirable effects of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Konzert® cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.

In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Konzert® cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Konzert cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In post-marketing surveillance for Konzert cream, 2%, the following were reported:

Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

Overdose

The information provided in Overdose of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

No information provided.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Konzert is based on data of another medicine with exactly the same composition as the Konzert of the medicine (Sertaconazole). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Konzert directly from the package or from the pharmacist at the pharmacy.
more... close

In a multiple dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42 -140 cm²; mean, 93 cm²), Konzert cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm²). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.

Site feedback

How easy to use our site?

Commentary is required, without it we won't know how to become better
The maximum length of review is 1000 symbols

Thanks!

You help us to become better