Zalain cream 2% tube 20 g

Instructions Zalain cream 2% tube 20 g

Composition

active ingredient: sertaconazole nitrate;

1 tube (20 g) contains 0.4 g of sertaconazole nitrate;

excipients: ethylene glycol and polyethylene glycol palmitostearate, lauryl macrogolglycerides, glycerol isostearate, light mineral oil, methyl parahydroxybenzoate (E 218), sorbic acid, purified water.

Dosage form

Cream.

Main physicochemical properties: semi-solid white cream of liquid consistency, odorless or with a faint odor of fat.

Pharmacotherapeutic group

Antifungal drugs for topical use.

ATX code D01A C14.

Pharmacological properties

Pharmacodynamics

Zalain is an antifungal drug, an imidazole derivative, with high fungicidal activity. The mechanism of action is to inhibit the synthesis of ergosterol and increase the permeability of the cell membrane, which leads to the destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp. and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton and Microsporium spp.) and pathogens that cause infectious diseases of the skin and mucous membranes, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics

There is no systemic absorption.

Indication

For the local treatment of fungal skin infections caused by dermatophytes and yeasts: athlete's foot, inguinal athlete's foot, smooth skin dermatomycosis, trichophytosis of the beard and mustache area, dermatomycosis of the hands, candidiasis, lichen planus.

Contraindication

History of hypersensitivity to any antifungal imidazole derivatives or to any other component of the drug.

Interaction with other medicinal products and other types of interactions

Not established. If it is necessary to use any other medicines at the same time, you should consult a doctor.

Application features

Zalain should not be used in ophthalmology. It should not be used orally. If irritation or hypersensitivity reactions occur during use of the drug, the drug should be discontinued and appropriate treatment should be administered. The drug is contraindicated in patients with hypersensitivity to sertaconazole or any antifungal derivatives of the imidazole group due to possible cross-sensitivity.

Before applying Zalain cream to the affected areas of the skin, wash your hands. The skin should be dry before applying the cream.

Patients should use acidic detergents with caution, as the spread of Candida spp. increases in an acidic environment.

Zalain contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

Zalain contains sorbic acid, which may cause local skin reactions (e.g. contact dermatitis).

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Use during pregnancy or breastfeeding

After external application of the drug in large quantities, no plasma levels were observed. Since the harmful effects of the drug on newborns or pregnant women have not been studied, before prescribing Zalain during pregnancy or breastfeeding, the benefit-risk ratio for the woman and the fetus/child should be assessed.

Method of administration and doses

Apply the cream 1 or 2 times a day (preferably at night or in the morning and evening) in a thin layer, gently and evenly on the affected area of skin, trying to capture approximately 1 cm of healthy skin around the affected area.

The duration of treatment depends on the etiology of the pathogen and the location of the infection. As a rule, approximately 4 weeks of treatment are recommended to achieve clinical remission with a negative result of microbiological control to prevent relapse, but in many cases clinical recovery occurs earlier - between 2 and 4 weeks.

Children

There are no data on pediatric use.

Overdose

Taking into account the concentration of the active substance and the recommended route of administration, intoxication is unlikely. However, in case of accidental ingestion of the medicinal product, appropriate symptomatic therapy should be applied.

Adverse reactions

The drug showed good tolerability when applied to both intact and damaged skin.

Local contact dermatitis (dry skin, burning, itching, urticaria) may occur. Hypersensitivity reactions, local transient erythematous reactions that do not require discontinuation of the drug are possible.

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C out of the reach of children.

Packaging

20 g in a tube, 1 tube in a cardboard box.

Vacation category

Without a prescription.

Producer

Ferrer International, S.A.

Joan Buscalla, 1-9, 08173 SANT CUGAT DEL VALLES, Barcelona, Spain.