Batrafen, nail polish 8% 3g (Sanofi-Aventis S.A., GERMANY)


Compound

The cream for external use contains the active component ciclopirox olamine , as well as a number of additional components: liquid paraffin, cetyl alcohol, myristyl alcohol, benzyl alcohol, lactic acid, stearyl alcohol, polysorbate 60, sorbitan stearate, water.
Batrafen varnish contains the active component ciclopirox and a number of additional components: ethyl acetate, copolymer of butyl hydromaleate and methoxyethylene, isopropanol.

When to start treatment

The sooner treatment is started, the faster the fungal disease can be eliminated and the development of a chronic form can be prevented. To determine the type of pathogen, consultation with a dermatologist or mycologist is necessary. With the help of laboratory tests, the doctor will be able to identify the causative agent of the fungal infection.

At the appointment, the dermatologist conducts a visual examination of the patient and pays attention to symptoms. To make a correct diagnosis and select effective treatment, a scraping is taken from the affected nail.

Laboratory methods for determining fungus:

In case of self-medication, there is a possibility that the fungal pathogens will not be completely destroyed. This is fraught with complications and the disease becoming chronic.

Healthy nails have a smooth nail plate and a natural pink tint. When affected by a fungus, the plate becomes dull, then yellow spots appear. The nails begin to thicken and split. Batrafen nail polish, according to the instructions and reviews, can be used not only as the main remedy, but also as a preventive measure against fungal nail infections.

pharmachologic effect

The medicine has an antifungal effect.

The product has a wide spectrum of influence and has good penetration ability. The antifungal effect of Batrafen is associated with inhibition of entry into the cell and induction of removal from it of components that are necessary for the functioning of the cell.

The active component of the drug ciclopirox olamine is effective against yeast-like fungi, dermatomycetes, molds, and other species. There is also an antibacterial effect against most gram-negative bacteria and gram-positive microorganisms.

How does varnish work?

Batrafen nail polish, according to reviews, is effective against microorganisms sensitive to cycloperox, and has a high medicinal concentration of the main active ingredient (8%) - cycloperox olamine.

Thanks to its liquid texture, the drug easily penetrates into the thickness of the nail and nail bed, where the most viable fungal infection is located. The varnish reliably seals the plate of the affected nail, preventing the supply of oxygen to microorganisms, which disrupts the process of their reproduction.

In this way, the infection cells are destroyed, mature spores are destroyed and the transport of substances necessary for their life is disrupted. The antibacterial effect of the product extends to mold and yeast-like fungal infections, as well as Trichomonas and mycoplasmas.

The drug is effective against:

  • dermatophytes;
  • streptococci;
  • staphylococci;
  • fungi such as Candida;
  • pathogens of microsporia;
  • sporotrichosis;
  • trichophytosis;
  • mycetomas.

Pharmacokinetics and pharmacodynamics

After Batrafen cream has been applied to a large surface of the skin and left for 6 or more hours, it may enter the bloodstream in small doses - approximately 1.3%. It is approximately 94–97% bound to plasma proteins in the body, the half-life is 1.7 hours. It is excreted in the urine.

Provided that nail polish is used for one day, the fungicidal concentrations are 20–30 times greater than plasma Cmax. of mycosis within 48 hours .

Manufacturer

Cream. Aventis Pharma Ltd., India. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Mardol Post, Ponda, Goa - 403404, India.

Nail polish. Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany.

Consumer complaints should be sent to the address in Russia: 125009, Moscow, st. Tverskaya, 22.

Tel.; Fax.

If the drug is packaged at Pharm CJSC, consumer claims should be sent to the address: 141345, Moscow region, Sergiev Posad district, Svatkovo village, p/o Svatkovo.

Tel/fax

Instructions for use of Batrafen (Method and dosage)

Antifungal agents Batrafen are used externally only.

Batrafen cream, instructions for use

The product in the form of a cream should be applied to areas that have been affected by the fungus twice a day. After application, dry the area treated with cream. It is necessary to practice therapy until the symptoms of the fungal disease disappear. Typically, treatment lasts about two weeks. To prevent recurrence of the disease, it is advisable to use the cream for another 1-2 weeks after the signs of the disease disappear.

Varnish Batrafen, instructions for use

Before applying varnish to the surface of the nail plate, you need to remove as much of the affected nail as possible, and file the remaining nail plate so that it is uneven. The product should be applied to the nail affected by the disease once a day, every other day, practicing this regimen during the first month of treatment. In the second month, varnish should be applied 2 times a week, in the third month – once a week.

During the treatment, once a week, the varnish must be removed using a solvent and the overgrown part of the nail plate must be cut off. If the varnish is damaged during the period between its application, only the part of the plate that was cleared of varnish should be coated with the product.

Treatment continues until symptoms disappear, but not longer than six months.

Batrafen, nail polish 8% 3g (Sanofi-Aventis S.A., GERMANY)

Compound.

active substance:
ciclopirox olamine10 mg
excipients:
benzyl alcohol - 10 mg; liquid paraffin - 115 mg; stearyl alcohol - 57.5 mg; cetyl alcohol - 57.5 mg; myristyl alcohol - 30 mg; polysorbate 60 - 35 mg; sorbitan stearate - 15 mg; lactic acid - 3 mg; purified water - up to 1 g
Nail polish1 g
active substance:
ciclopirox80 mg
excipients:
butylhydromaleate and methoxyethylene copolymer (50% solution in isopropanol) - 300 mg; ethyl acetate - 310 mg; isopropanol - 310 mg

Description of the dosage form.

The cream is almost white to white in color.

Clear nail polish.
Pharmachologic effect. Antifungal.

Pharmacodynamics.

Cream for external use.

Batrafen is a broad-spectrum antifungal agent with good penetrating ability. The active ingredient ciclopirox olamine is effective against dermatomycetes, yeast-like, mold and other types of fungi. It has an antibacterial effect against gram-positive strains of bacteria and most gram-negative pathogens.

Nail polish.

Broad-spectrum antifungal drug.
Active against Trichophyton rubrum
,
Trichophyton mentagrophytes
,
Trichophyton verrucosum
,
Trichophyton tonsurans
,
Trichophyton quinckeanum
,
Trichophyton equinum
,
Trichophyton concentricum
,
Trichophyton epilans
,
ferrugineum
,
gallinae

,

Trichophyton schoenleinii , Trichophyton soudanense
,
Tri chophyton terrestre
,
Trichophyton violaceum
,
Microsporum canis
,
Microsporum gypseum
,
Microsporum audouinii
,
Microsporum langeronii
,
Microsporum nanum
,
Epidermophyton floccosum
,
Candida
(
Candida albicans
,
Candida tropicalis
,
Candida krusei
,
Candida parapsilosis
,
Candida pseudotropicalis
,
Candida lipolytica
,
Candida guilliermondii
,
Candida brumpti
,
Candida util is
,
Candida viswanathii
),
Cryptococcus neoformans
,
Histoplasma capsulatum
,
Sporotrichum schenckii
,
Torulopsis glabrata
,
Blastomyces dermatitidis
,
Paracoccidioides brasiliensis
,
Saccharomyces cerevisiae
,
Torula bergeri
,
Aspergillus fumigatus
,
Aspergillus flavus
,
Aspergillus niger
,
Penicillium chrysogenum
,
Penicillium notatum
,
Absidia cory mbifera
,
Mucor miehei
,
Paecilomyces variotii
,
Fusarium solani
,
Madurella grisea
,
Madurella mycetomatis
,
Allescheria boydii
,
Cladosporium carrionii
,
Cladosporium trichoides
,
Phialophora jeanselmei
,
Phialophora pedrosoi
,
Phialophora gougerotti
,
Hormodendrum dermatitidis
,
Pyrenochaeta romeroi
,
Leptosphaeria senegalensis
. The antifungal effect of ciclopirox is based on inhibiting the entry into the cell and inducing the removal from the cell of components necessary for its life. It has an antibacterial effect against gram-positive and most gram-negative pathogens. Suppresses the development of mycoplasmas and trichomonas.

Pharmacokinetics.

Cream for external use.

When the cream is applied to large surfaces (750 cm2) and for a long time (6 hours or more), it can be detected in the blood (1.3% of the dose), with 94–97% bound to plasma proteins, T1/2 is 1.7 h, excreted by the kidneys.

Nail polish.

The values ​​of fungicidal concentrations with one-day use of nail polish exceed the plasma Cmax by 20-30 times (plasma Cmax for dermatophytes, Candida fungi, molds and yeast-like fungi - 0.98-3.9 μg/ml, for mycoplasma and
Trichomonas vaginalis
- 7 .8–31.3 µg/ml).

Indications.

Cream for external use

Fungal skin lesions.

Nail polish

Fungal diseases of nails.

Contraindications.

● increased sensitivity to the components of the drug;

● period of pregnancy and lactation;

● children under 10 years of age.

Side effects.

For all dosage forms

Rarely - itching or burning sensation. With prolonged external use of the drug, sensitization phenomena are possible.

Optional for nail polish

Local reactions:

rarely - skin irritation, hyperemia and peeling of the skin around the affected nail; allergic reactions.

Interaction.

The effect of the cream is enhanced by systemic antimycotic agents.

Method of administration and dose.

Externally.

Cream for external use.

The cream is applied to the affected areas of the skin 2 times a day, followed by drying. Treatment should continue until the symptoms of the disease disappear (usually 2 weeks). To prevent relapse of the disease, it is recommended to use the drug for another 1–2 weeks after the disappearance of all clinical symptoms.

Nail polish.

Before the first application of Batrafen®, nail polish, you should remove as much of the affected nail as possible with scissors and file the remaining nail plate to create an uneven surface. The varnish is applied in a thin layer to the affected nail once a day, every other day during the first month, during the second month - 2 times a week, during the third - once a week. Once a week (for example, on Sunday), the varnish is removed using a regular solvent or scraped off after a warm bath, and the growing affected part of the nail plate should be removed again with scissors. If the varnish coating is damaged during the period between applications of varnish, then the varnish should be reapplied only to those areas of the nail where the varnish coating is damaged.

The duration of treatment depends on the severity of the nail plate fungus, but the treatment period should not exceed 6 months.

Special instructions.

Avoid contact of the cream with the eyes.

To prevent the varnish from drying out, close the lid tightly after use. To prevent the lid from sticking, avoid getting varnish on the threads. After opening the bottle, the drug can be used for 6 months subject to storage conditions.

It is not recommended to use cosmetic nail polish during treatment.

Release form.

Cream for external use, 1%.

15 g of cream in aluminum tubes. Each tube is placed in a cardboard box.

Nail polish, 8%.

3 or 6 g of the drug in a glass (type III), colorless transparent bottle, equipped with a screw cap with a brush for applying varnish. 1 fl. placed in a cardboard box.

Manufacturer.

Cream.

Aventis Pharma Ltd., India. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Mardol Post, Ponda, Goa - 403404, India.

Nail polish.

Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany.

Consumer complaints should be sent to the address in Russia: 125009, Moscow, st. Tverskaya, 22.

Tel.; Fax.

If the drug is packaged at Pharm CJSC, consumer claims should be sent to the address: 141345, Moscow region, Sergiev Posad district, Svatkovo village, p/o Svatkovo.

Tel/fax

Conditions for dispensing from pharmacies.

Over the counter.

Analogs

Level 4 ATX code matches:
Mikonorm

Undecin

Gentian violet

Zinkundan

Exoderil

Exiter

Lotseril

Lamisil Dermgel

Lamisil Uno

Lamisil

Salicylic acid

Salicylic ointment

Keto Plus

Exifin

Fungoterbin

Mycoseptin

Thermikon

Nitrofungin

Sulsena

Baziron AS

Analogues of the drug Batrafen in the form of an ointment are the drugs Ciclopirox , Dafnedzhin .

An analogue of Batrafen varnish is Loceryl .

Which is better: Batrafen or Lotseril?

Lac Loceryl affects the structure of the fungal cell membrane, as well as the process of their biosynthesis. The active ingredient of the drug is amorolfine . In general, the effect of this drug is similar to that of Batrafen, and its price is slightly higher.

Indications

According to the instructions, the varnish is used to eliminate the symptoms of the following diseases:

  • pityriasis versicolor;
  • fungal nail diseases;
  • dermatosis;
  • fungal vaginitis and vulvovaginitis;
  • candidiasis;
  • tinea pedis.

The drug is used as a basic, prophylactic and additional agent in complex therapy for the treatment of all types of fungal infections.

special instructions

Treatment with Batrafen varnish is more effective the earlier it is started. The drug will show a good result if the area covered by fungal microflora occupies no more than 70% of the nail plate, and its base (matrix) and surrounding skin are not infected. With a larger coverage area, antifungal therapy in the form of tablets and ointments must be added to the medicinal varnish.

The varnish can only be used externally. Contact with mucous membranes must be avoided.

During treatment, you should not use manicure varnish or extend your nails, as the effectiveness of treatment with Batrafen is reduced.

All means and instruments during treatment must be strictly individual. After use, it is important to ensure disinfection of materials and treatment areas. It is useful to combine treatment with Batrafen varnish with taking vitamins and medications that increase immunity.

Contraindications

Batrafen nail polish is an effective and safe product, but it has a number of contraindications.

It cannot be used:

  • during pregnancy;
  • during breastfeeding;


    Batrafen nail polish should not be used during breastfeeding.

  • children under 10 years old;
  • persons with individual intolerance to components.

Side effects

Batrafen nail polish rarely provokes complications and unpleasant reactions.

Side effects include skin manifestations:

  • itching;
  • burning;
  • peeling;
  • redness;
  • irritation;
  • edema;
  • allergic reaction.

If such symptoms occur, you should stop using the product and change to a similar drug suggested by a dermatologist.

To reduce the likelihood of such manifestations, apply varnish only to damaged areas of the skin and nail plate.

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