Bifonal-Zdorovye, gel of 1% 15 g
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: D01A C10
Release form: Soft dosage forms. Gel.
General characteristics. Structure:
International and chemical name: бифоназол; 1-(a-biphenyl-4-ulbezil) imidazole;
main physical and chemical properties: gel of white color, a homogeneous consistence, with a slight specific smell;
structure: 1 g of gel contains a bifonazol of 10 mg;
excipients: карбопол (carbomer), glycerin, solution of ammonia of 15%, alcohol of ethyl 96% or alcohol rectified, metilparagidroksibenzo-at (нипагин), пропилпарагидроксибензоат (нипазол), the water purified.
Pharmacological properties:
Pharmacodynamics. Bifonal-Zdorovye treats antifungal broad-spectrum agents. Depending on a dose possesses fungistatic or fungicidal action. The effect of drug is connected with disturbance of synthesis of the ergosterol which is a part of a cellular membrane of mushrooms.
It is active concerning dermatophytes, barmy (including the sorts Candida), mold (Malassezia furfur) and other mushrooms, gram-positive cocci. Also Corynebacterium minutissimum are sensitive to drug.
Pharmacokinetics. At topical administration of a bifonazol only of 0,6-0,8% of active agent also 2-4% - tissues of the inflamed skin are absorbed by tissues of healthy skin. Active agent is absorbed by fungal cells within 10-30 min. after use. In 6 h concentration of a bifonazol in upper and papillary layers of epidermis makes about 1 mg/cm2 that corresponds or exceeds the minimum overwhelming concentration for main types of the mushrooms causing dermatomycoses.
Concentration of a bifonazol in a blood plasma after topical administration makes 5 ng/ml.
Indications to use:
The dermatomycoses caused by dermatophytes, yeast, mold and other mushrooms (mycoses of feet, brushes, smooth skin and folds of skin; multi-colored deprive, superficial candidiases); erythrasma.
Route of administration and doses:
Gel is applied once a day in the evening before going to bed with a thin layer on an affected area of skin and rubbed. The single dose at the rate on surface area of the size of a palm makes a column about 5 mm long.
Treatment duration at mycoses of foot and spaces between foot fingers - 3 weeks; at mycoses of smooth skin, a brush and folds of skin - 2-3 weeks; at multi-colored herpes and an erythrasma - 2 weeks; at superficial candidiases - 2-4 weeks.
Features of use:
Use of drug in the I trimester of pregnancy is possible only according to strict indications. Treatment of babies drug can be carried out only under observation of the doctor.
Side effects:
Local reactions - easy reddening, irritation of skin, in some cases - burning and a pricking are seldom noted. At individual sensitivity at patients allergic reactions are possible.
Interaction with other medicines:
Medicinal interaction is not described.
Contraindications:
Hypersensitivity to a bifonazol; allergic reactions to drug excipients.
Overdose:
About cases of overdose it was not reported.
Storage conditions:
In protected from light and the place, unavailable to children, at a temperature from 8 °C to 25 °C.
Period of validity – 2 years.
Issue conditions:
Without recipe
Packaging:
Gel of 1%, on 15 g in tubas.