Composition, form of production and packaging
? Cream for external use 2% white, soft, odorless or with a faint odor of fat.
1 g
sertaconazole nitrate 20 mg
Auxiliary substances: ethylene glycol and polyethylene glycol palmitostearate - 20 g, polyglycolated 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 .
20 g - aluminum tubes (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Antifungal preparation of a broad spectrum of action, an imidazole derivative and benzothiophene.
It is active against pathogenic fungi Candida albicans, Candida tropicalis, Candida spp., Pityrosporum orbiculare, dermatophytes Trychophyton spp., Microsporum spp. and pathogens of skin and mucous membrane infections (gram-positive strains of Streptococcus spp. and Staphylococcus spp.).
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 local application of sertaconazole, nitrate in the blood and urine is not detected.
INDICATIONS
Superficial mycosis of the skin:
- mycoses of shins, feet and hands;
- Mycosis of the trunk;
- mycosis beard;
- Candidiasis;
- colored lichen.
DOSING MODE
The cream should be applied to the affected areas of the skin with a uniform thin layer 2 times / 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. Symptoms of the disease disappear, usually in 2-4 weeks. The recommended duration of treatment is 4 weeks.
SIDE EFFECT
Local reactions: contact dermatitis.
Possible rapid erythematous reactions that do not require drug withdrawal.
CONTRAINDICATIONS
- hypersensitivity to sertaconazole, imidazole derivatives or other components of the drug.
PREGNANCY AND LACTATION
In pregnant women, the safety of the drug has not been specifically studied. The use of the drug during pregnancy is possible only in cases where the intended benefit of therapy for the mother exceeds the potential risk to the fetus.
During the lactation period, do not apply the cream to the mammary glands. Data on the use of the drug during lactation is not available at this time, therefore, if it is necessary to prescribe the drug of the mother during the lactation period, the issue of stopping breastfeeding should be individually addressed.
SPECIAL INSTRUCTIONS
The drug is not used in ophthalmic practice.
It is not recommended to use acidic detergents (in an acidic environment multiplying the fungi of Candida spp.).
OVERDOSE
Given the external method of use, an overdose of Zalain В® is unlikely. At casual reception of a preparation inside it is shown symptomatic treatment.
DRUG INTERACTION
Clinically significant drug interaction of Zalain В® with other drugs has not been established.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
