Zalain - instructions for use, doses, side effects, contraindications

100 g of cream contains 2 grams active ingredient - sertaconazole nitrate (20 mg sertaconazole nitrate / 1 g cream), and same Excipients: ethylene glycol and polyethylene glycol palmitostearate 20 g,, polyglycolized saturated glycerides 5 g, glycerol isostearate 2 g, paraffin oil 8 g, methyl p-hydroxybenzoate 0.1 g, sorbic acid 0.1 g, purified water up to 100 g.

Description:

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

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D Dermatology

Pharmacodynamics:

Sertaconazole is a derivative of imidazole and benzothiophene with a broad spectrum of action against pathogenic fungi (Candida albicans, C. Tropicalis, S. Sp., Pityrosporum orbiculare), dermatophytes (Trichophyton and Microsporum) and pathogens of infections of the skin and mucous membranes (Gram-positive strains of staphylo- and streptococci). It has fungistatic and fungicidal action in therapeutic doses.

The mechanism of action of sertaconazole is to inhibit the synthesis of ergosterol, the main sterol of fungal and yeast membranes, and to increase the permeability of the cell membrane, which leads to lysis of the fungal cell.

Pharmacokinetics:

With topical application sertaconazole nitrate in the blood and urine are not detected.

Indications:

Local treatment of superficial skin mycoses: dermatomycosis, Tinea pedis, Tinea crusis, Tinea corporis, Tinea barbae, Tinea manus, Candida (Monolisiasis), and Pityiriasis versicolor (Pityrosporum orbiculare).

Contraindications:

Hypersensitivity to antifungal agents (imidazole derivatives) or cream auxiliaries.

Pregnancy and lactation:

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

During lactation, the cream is not applied to the mammary glands. There are currently no data on the use of the drug during lactation, therefore, if the drug is to be used, the question of stopping breastfeeding with a doctor should be resolved.

Dosing and Administration:

The cream is applied to the affected areas of the skin with a uniform thin layer twice a day with the capture of approximately 1 cm of the surface of healthy skin.

The duration of treatment depends on the causative agent etiology and localization of the infection. As a rule, the symptoms disappear after 2-4 weeks. The recommended duration of treatment is 4 weeks.

Side effects:

Contact dermatitis.

Possible rapid local erythematous reactions that do not require withdrawal of the drug.

Overdose:

Given the external way of use, an overdose of Zalain is unlikely. If you randomly take the drug inside you need to carry out symptomatic treatment.

Interaction:

No interaction was found.

Special instructions:

Do not use in ophthalmic practice.

It is not recommended the use of acidic detergents (in the acidic environment, multiplication of fungi such as candida).

There are no data on the use of the drug in children.

Form release / dosage:

Cream for external use 2%.

Packaging:

In tubes of 20 g. The tube together with the instruction for use is packed in a cardboard box.

Storage conditions:

Store the drug at a temperature below 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015678 / 01

Date of registration:20.03.2009 / 25.08.2016

Expiration Date:Unlimited

The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Manufacturer: & nbsp

FERRER INTERNACIONAL, S.A. Spain

Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Information update date: & nbsp10.10.2017

Illustrated instructions

Instructions

Zalain® (Zalain®)