2010/12/16

Batrafen

Release form, composition and packing Batrafen 

Gel for external use watery, almost white.

1 year tsiklopiroks 7.7 mg.

Other ingredients: 2-propanol, sodium docusate, octyldodecanol, dimethicone copolyol 190, carbomer 4,000,000, sodium hydroxide, water

Clinico-pharmacological group: antifungals for topical use.

Pharmacological action

Tsiklopiroks and its derivatives - tsiklopiroksolamin - antifungal agent wide spectrum of action. Tsiklopiroks has a broad spectrum fungicide (fungicide) action and is effective when applied topically on dermatomitsetov, yeasts, molds and other fungi (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton tonsurans, Trichophyton quinckeanum, Trichophyton equinum, Trichophyton concentricum, Trichophyton epilans , Trichophyton ferrugineum, Trichophyton gallnae, Trichophyton schoenleinii, Trichophyton soudanense, Trichophyton terrestre, Trichophyton violaceum, Microsporum canis, Microsporum gypseum, Microsporum audouini, Microsporum langeroni, Microsporum nanum, Epidermophyton floccosum, Candida (Candida albicans, Candida tropicalis, Candida krusei, Candida parapsilosis , Candida pseudotropicalis, Candida lipolytica, Candida quiliermondii, Candida brumpti, Candida utilis, Candida viswanathii), Cryptococcus neoformans, Histoplasma capsulatum, Sporotrichum schenckii, Torulopsis glabrata, Blastomyces dermatidis, Paracoccidioides braziliensis, Saccharomyces cerevisiae, Torula Bergeri, Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Penicillium chrysogenum, Penicillium notatum, Absidia corymbifera, Mucor miehei, Paecilomyces varioti, Fusarium solani, Madurella grisea, Madurella mycetomi, Allescheria boydii, Cladosporium carrionii, Cladosporium trichoides, Philophora jeanselmei, Philophora pedrosoi, Philophora gougeroti, Hormodendrum dermatidis, Pyrenochaeta romeroi , Leptosphaeria senegalensis, Scopulariosus brevicaulus, Malassezia furfur).

Tsiklopiroks also active against some strains of Gram-positive and most strains of Gram-negative bacteria acts bacteriostatic. Suppresses the development of mycoplasma and trichomonas.

Tsiklopiroks active against the major causative agents of onychomycosis. Nail polish is used to treat fungal nail infections. Most effective in the early stages of onychomycosis with distal type of nail infections (not more than one-half or one third of the nail), without involvement of the matrix, a superficial onychomycosis and aftercare of onychomycosis after systemic therapy to prevent relapse.

With multi-colored shingles clinical and mycological improvement is noted not earlier than 2 weeks of treatment Tsiklopiroksom.

Pharmacokinetics.

Tsiklopiroks (tsiklopiroksolamin) when applied topically to quickly penetrate the skin, its appendages and mucous membranes. After 1.5-6 hours after application, its concentration in these tissues exceed the minimum inhibitory concentrations (MIC) against pathogenic fungi many times (MIC for dermatophytes, fungi of the genus Candida, molds and yeasts - 0.98-3.9 mg / ml; IPC for mycoplasma and Trichomonas vaginalis - 7.8-31.3 mg / ml). When applying Tsiklopiroksa over a large surface (750 cm ^ 2) and for a long time (6 hours or more) can be detected in blood (1.3% dose), with 94-97% bound to plasma proteins, T1 / 2 is about 1.7 hours , excreted by the kidneys.

Tsiklopiroks nail polish. Tsiklopiroks begins to penetrate the nail plate during the first hours after application of varnish. Forms a physical barrier that prevents reinfection. When fungal nail penetration Tsiklopiroksa increases.

Tsiklopiroksa effective concentration in the nails of fingers reached after 7 days of treatment, but in the toenails feet - after 14 days of lecheniya.Dlya Tsiklopiroksa penetration into the deeper layers in contact with hyponychial pillow, it may take from 14 to 30 days. Tsiklopiroks accumulate in the nails of toes is 4 times more than the nails of fingers. Long deposited at the site of infection.

The effective concentration Tsiklopiroksa persists for 7-14 days after cessation of treatment. Tsiklopiroks detected in the serum after its application to the nails of all fingers.

Statement
tsiklopiroks (tsiklopiroksolamin) is used to treat fungal infections of the skin and mucous membranes caused by susceptible to the drug mushrooms: fungal infections of the skin, including multi-colored shingles, candidiasis (for the application of cream and a solution for outdoor applications);
vaginitis, vulvovaginitis, colpitis (including recurrent course), especially vaginal candidiasis (for use vaginal cream and suppositories);
mycosis of nails, or onychomycosis (for application of nail polish);
prevention of fungal infections (for application of powder).

Dosing regimen

For the treatment of fungal skin lesions Tsiklopiroks as a cream or solution applied to the affected skin areas 2 times a day. After applying the cream pinch of skin is dried. Solution Tsiklopiroksa rubbed into the skin. Treatment is usually continued for 2 weeks before the disappearance of all symptoms. Then, to prevent relapse Tsiklopiroks apply for another 1-2 weeks.

Avoid getting Tsiklopiroksa in the eye.

For the treatment of vaginitis, vulvovaginitis, colpitis usually used vaginal cream or vaginal suppositories Tsiklopiroksa. Cream injected deep into the vagina using the supplied tip at a dose of 5 g. 1 time a day at bedtime. Duration of treatment is determined individually, but it should not constitute more than 14 days. The clinical effect is usually observed after 6 days. In the event that simultaneously with colpitis noted skin lesions in the vagina, on this site cause vaginal cream Tsiklopiroksa with a cotton swab.

Vaginal suppositories appoint 1 suppository (100 mg), 1 a day for 3-6 days, depending on the severity of the disease. To prevent re-infection should be the simultaneous treatment of sexual partners.

For the treatment of onychomycosis Tsiklopiroks in the form of nail varnish applied 1 time per day with a thin layer on the affected nail. Before the first application was removed as much of the affected nail and napilivayut it with a nail file to create an uneven surface. Once a week the entire layer of varnish was removed using a conventional solvent, while seeking to remove as much of the affected material. During the second month of treatment is sufficient Half Tsiklopiroksa varnish applications per week, starting from the third month - once a week. Duration of treatment depends on the severity of injuries, but should not exceed 6 months, the average duration - about 12 weeks. During the treatment of onychomycosis is not recommended to use cosmetic nail varnish.

In order to prevent fungal infections in patients at high risk of their occurrence in the form of powder Tsiklopiroks recommend to pour into the socks and / or footwear, the duration of the use of powdered set individually

Side effect

Local allergic reactions (rare): itching and burning of the skin or mucous membranes at the site of application, the redness and peeling of the skin surrounding the affected nail.

Contraindications
idiosyncrasy (including history of hypersensitivity) tsiklopiroksa (tsiklopiroksolamina).
pregnancy and lactation;
children under 10 years of age.

Pregnancy and lactation

In pregnancy, drugs Tsiklopiroksa used only under strict indications (perhaps for reasons and under medical supervision).

Data about the safety of Tsiklopiroksa during lactation (breastfeeding) is not available

Cautions

Duration of application of varnish Tsiklopiroksa should not exceed 6 months; vaginal cream - 2 weeks. Lack of effect in the treatment of onychomycosis or ringworm within 4 weeks requires further diagnosis.

The use of drugs that improve blood circulation, vitamins, stimulants of immunity can reduce treatment time.

In the case of treatment of vaginitis / vulvovaginitis in order to prevent re-infection recommend simultaneous treatment of sexual partner. In order to prevent reinfection should strictly comply with the measures of general hygiene.

Onihomikozah therapeutic effect depends on the regular disinfection of shoes (gloves). If the damage clearcoat enough again to lubricate the damaged areas of the drug. Opened a bottle of nail polish can be stored at room temperature in a dark place for 3 months. With long-term external application Tsiklopiroksa possible phenomenon of sensitization (contact dermatitis).

In infants and toddlers, as well as during pregnancy Tsiklopiroks used only under strict indications.

Avoid getting products in the eye Tsiklopiroksa

Overdose

Currently, cases of overdose were reported Tsiklopiroksa

Drug Interactions

Not established clinically significant interactions Tsiklopiroksa (tsiklopiroksolamina) with other drugs.

During the treatment of onychomycosis is not recommended to use both the cosmetic nail varnish.

Effect Tsiklopiroksa increase systemic antifungal drugs (terbinafine, itraconazole, fluconazole

Conditions and terms of

Store in a dry place, protected from light, place inaccessible to children, at a temperature above 25 ° C.