ZALAIN (Cream for external application)

Active material: Sertaconazole
When ATH: D01AC14
CCF: Antifungal agents for external use
ICD-10 codes (testimony): B35.0, B35.2, B35.3, B35.4, B36.0, B37.2
When CSF: 08.02.01
Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary)

Pharmaceutical form, composition and packaging

◊ Cream for external application 2% white, soft, and odourless or weak smell fat.

Excipients: ethylene glycol and polyethylene glycol pal′mitostearat, glycerides of poliglikolizirovannye saturated, glycerol isostearate, paraffin oil, methyl n-gidroksibenzoat, sorbic acid, Purified water.

20 g – aluminum tuba (1) – packs cardboard.

Pharmacological action

Broad-spectrum antifungal medication, imidazole derivative and benzothiophene. At therapeutic doses, has fungistatic and fungicidal activity.

It is active against pathogenic fungi Candida albicans, Candida tropicalis, Candida spp., Orbicular Pityrospores, dermatomycosis Trychophyton spp., Microsporum spp. and infections of the skin and mucous membranes (Gram-positive strains of Streptococcus spp. and Staphylococcus spp).

Sertakonazola mechanism of action is inhibition of synthesis ergosterola (main sterola membranes of fungi and yeast), and increase the permeability of the cell membrane, which leads to cell lysis fungus.

Pharmacokinetics

The local application of sertakonazola nitrate in blood and urine is not found.

Testimony

Superficial fungal infections of the skin:

-Mycosis drumsticks, feet and hands;

-Mycosis torso;

-Mycosis beard;

-candidiasis;

- Multi-colored shingles.

Dosage regimen

Cream should be applied on the affected areas of skin a uniform thin layer 2 times per day with the seizure of about 1 see healthy skin surface.

Duration of treatment depends on the etiology of the pathogen and localization of infection. Symptoms disappear, usually, through 2-4 of the week. The recommended duration of treatment – 4 of the week.

Side effect

Local reactions: contact dermatitis.

Possible fast passing erythematous reactions, not requiring the preparation.

Contraindications

- Hypersensitivity to sertaconazole, derived imidazola or other components of the drug.

Pregnancy and lactation

Adequate and well-controlled clinical studies on the safety of Zalaina^® in pregnancy and lactation has not been. Use of the drug during pregnancy is possible only in cases, the projected benefits of therapy for a mother than the potential risk to the fetus.

Lactation should not apply the cream on breast. Data on the use of drugs during lactation, there is currently no, Therefore, if necessary, the appointment of the drug to the mother during lactation should individually decide on the termination of breastfeeding.

Cautions

The drug is not used in ophthalmic practice.

Do not use acid detergents (in acidic Wednesday amplified reproduction of fungi Candida spp.).

Overdose

Given the external method of application, drug overdose Zalain^® unlikely. In case of accidental intake of the drug inside shown symptomatic treatment.

Drug Interactions

Clinically significant drug interaction drug Zalain^® with other drugs is not established.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or below 25 ° C. Shelf life – 3 year.