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

Antifungal means of a wide spectrum of action. It acts fungicidally on dermatophytes (trichophyton, microsporum, epidermophyton); fungistatrically - on yeast-like, mold fungi (Aspergillus ferrus, Scopulariopsis brevicautus); Malassezia fufur. Active with respect to Corynebacterium minutissimum (MIC varies from 0.5 to 2 μg / ml), Gram-positive cocci, with the exception of enterococci (MIC of 4-16 μg / ml).

The target of the drug is ergosterol - the most important component membranes of fungi.In contrast to other imidazoles, the synthesis of ergosterol is inhibited in two stages of its formation, which leads to structural and functional damage to the fungal cell membrane. Minimum - effective concentration - 5 ng / ml for a duration of exposure of at least 6 hours; at a concentration of 3 ng / ml inhibited the growth of rapidly proliferating mycelium Trichophyton mentagrophytes. Ha yeast-like fungi of the genus Candida renders fugistaticheskoe, and in concentration of 20 ng / ml - fungicidal action.

Pharmacokinetics:

Absorption - 0,6-0,8%, the concentration in the plasma is not determined (below the detection limit - 1 ng / ml). When applying the cream to the inflamed skin, the absorption is 2-4%, the concentration in the plasma is 2 ng / ml. After 6 hours after application, the concentration in the skin reaches the minimum effective concentration or many times exceeds the main fungi that cause dermatomycosis: 1 mg / cm² in the upper layer of the epidermis (Stratum comeum), 5 mg /cm² at Stratum papillare. T_1/2of the skin is 19-32 h (depends on its density). The duration of the skin in the cream is 48-72 hours, for the solution - 36-48 hours.

Indications:

The cream for external use is indicated for the treatment of the following diseases: microsporia, trichophytosis of smooth skin and scalp, favus, rubrofitia, mycosis of feet and brushes, inguinal epidermophytia, multicolored lichen, erythrasma.

Superficial candidiasis of the skin, candidiasis of nail ridges, nails, genitals, interdigital intertrigo, hyperhidrosis of feet, onychomycosis.

Contraindications:

Hypersensitivity (including on cetyl stearol and lanolin), the period of lactation.

Carefully:Breast age, pregnancy (I trimester).

Pregnancy and lactation:

Data from the studies show that the drug does not have any negative effects on the body of the mother and the fetus. However, the use of the drug in the first trimester of pregnancy is possible only by strict indications.

Data on the use of the drug in the period of lactation is not available.

Dosing and Administration:

Outwardly.

Apply to the affected skin with a thin layer 1-2 times a day. The duration of treatment depends on the nature of the disease, the size and location of the lesion. The course lasts 2-5 weeks. After the elimination of clinical manifestations of mycosis, treatment is continued for 10-15 days, applying the cream 1 time per day to prevent relapse.

Use in infants is possible only under the supervision of a doctor. In the first 3 months of pregnancy apply only on strict indications.

With onychomycosis treatment is carried out with subsequent removal of the nail plate.The amount of the drug covering the entire affected nail is applied a thin layer once a day from the dosing device. Fingernails or toenails after applying ointments or cream on them should be covered with band-aid and bandage for 24 hours. The dressing should be changed every day; then, after removing the bandage, the fingers or hands should be lowered into warm water for 10 minutes. After that, the softened infected nail tissue is removed using a scraper. Then the processed nail is dried, it is again applied to the cream and covered with a ready-to-use plaster. The treatment is continued until the nail bed becomes smooth and all of its softened part is removed (approximately 7-14 days, depending on the size of the affected area and the thickness of the nail). The cream acts only on the sick part of the nail. If irritation occurs, then the skin around the nail should be greased with zinc paste. To treat small nails, the patch should be cut in half. After the nail is removed, the paste should be treated. Although clinically inflammatory phenomena against the background of treatment are resolved quickly (the itching of the skin in the lesion foci disappears by day 5, inflammatory phenomena by 12-13 days,peeling by the 13-14 day of treatment), it is necessary to continue treatment for at least 3-4 weeks to ensure the sanation of foci of infection.

Features of the drug during the first admission or when it is canceled

There is no information.

Side effects:

Hyperemia and skin irritation, burning sensation; local reactions along the edges or on the nail bed (irritation, hyperemia, maceration and skin peeling, contact dermatitis); allergic reactions, body aches, eczema, skin itching, vesicular, rash. These side effects are reversible and disappear after discontinuation of therapy.

Overdose:

There is no information.

Special instructions:

In the absence or inadequate efficacy, the patient should be additionally examined (state of immunity, blood, endocrine system, microcirculation of the affected area) and adjust the treatment in accordance with the results of the survey.

Use in infants is possible only under the supervision of a doctor.

In the first 3 months of pregnancy apply only on strict indications.

The result of treatment of onychomycosis depends on careful removal of the damaged part of the nail. Repeated use of the attached patches after contact with the cream is not possible, it should be replaced by another.waterproof plaster, previously appropriately cut.

Effect on the ability to drive transp. cf. and fur:There is no information.

Form release / dosage:Cream for external use, 1%.

Packaging:

By 30 grams in aluminum or laminate tubes or tubes of combined material, or 30 g in cans or bottles of dark glass.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date indicated on the label.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001299

Date of registration:29.11.2011

Expiration Date:Unlimited

The owner of the registration certificate:SAMARAHEDPROM, JSC SAMARAHEDPROM, JSC Russia

Manufacturer: & nbsp

SAMARAHEDPROM, JSC Russia

Representation: & nbspSAMARAHEDPROM, JSCSAMARAHEDPROM, JSC

Information update date: & nbsp14.02.2017

Illustrated instructions

Instructions

Beefasam (Bifasam)