Expiration date: 04/2025

Structure and Composition:

Cream for topical application. 1 g contains 20 mg sertaconazole nitrate

Excipients: ethylene glycol palmitostearate saturated polyglycolized glycerides glycerin isostearate paraffin oil methyl parahydroxybenzoate sorbic acid, purified water

in tubes of 20 g in paper cartons 1 tube.

Description pharmaceutical form:

White soft cream, odorless or with a faint odor of fat.

Pharmacokinetics:

When applied topically in the blood and the urine is detected.

Description of the pharmacological actions:

Sertaconazole is imidazole and benzothiophene derivatives with broad spectrum of activity against pathogenic fungi (Candida spp., Including Candida albicans, Candida tropicalis Pityrosporum orbiculare), dermatophytes (Trichophyton and Microsporum) pathogens and infections of the skin and mucous membranes (gram-positive strains staphylo - and streptococci). At therapeutic doses has fungistatic and fungicidal effect.

It inhibits the synthesis of ergosterol, the major membrane sterol of fungi and yeast, increases the permeability of the cell membrane, resulting in lysis of the cells of the fungus.

Indications:

Local treatment of superficial fungal infections of the skin:

• ringworm (including Tinea pedis, Tinea corporis, Tinea barbae (beard mycosis), Tinea manus, Tinea cruris)
  
• candidiasis (Monolisiasis)
  
• Pityriasis versicolor (Pityrosporum orbiculare).
  

Contraindications:

Hypersensitivity to antifungal agents (imidazole derivatives) or auxiliary substances cream.

Application of pregnancy and breastfeeding:

In pregnant women, the safety of the drug has not been studied specifically. Therefore, the use of sertaconazole during pregnancy is possible if the potential benefit to the mother outweighs the potential risk to the fetus.

During lactation the cream should not be applied on the breast. Data on the use of the drug during lactation no, so should resolve the issue of termination of breastfeeding with your doctor, if necessary, use of the drug.

Side effect:

Contact dermatitis. The ability to quickly pass local erythematous reactions that do not require discontinuation of therapy.

Drug Interactions:

Not found.

Dosage and administration:

Outwardly. The cream is applied to the affected skin even, thin layer twice a day with the seizure of about 1 cm of healthy skin. The duration of treatment depends on the etiology of the pathogen and the localization of the infection. Usually, symptoms disappear within 2-4 weeks. The recommended duration of treatment - 4 weeks.

Overdose:

When applied topically overdose is unlikely. If you accidentally taking the drug inside is necessary to symptomatic treatment.

Special instructions:

Do not use in ophthalmic practice.

Do not use acidic detergents (such as Candida fungi reproduction is enhanced in an acidic environment).

Data on drug use among children there.