Mikospor Set - instructions for use, dose, side effects, contraindications

Active substanceBifonazole + UreaBifonazole + Urea

Similar drugsTo uncover

Mycospor® Set

ointment externally

Bayer AG Germany

Dosage form: & nbspointment for external use

Composition:

In 100 g of ointment contains:

active ingredients: bifonazole 1 g, urea 40 g;

auxiliary ingredients: wax bee white 5 g, white petrolatum 34 g, lanolin 20 g.

Description:

Homogeneous ointment of white color with a yellowish tinge.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.C.60 Bifonazole in combination with other drugs

Pharmacodynamics:

Bifonazole, the first active substance of the Ointment Mikospor®® Kit, is an imidazole derivative and has a broad spectrum of antimycotic action. Bifonazole has fungicidal action against dermatophytes (in particular, with respect to Trichophyton spp.). The complete fungicidal effect is achieved with a concentration of 5 μg / ml bifonazole and an exposure time of at least 6 hours.

Bifonazole has a fungistatic effect against yeast and mold fungi, and Malassezia furfur. When affected by yeast fungi, for example, Candida species, at a concentration of 1-4 μg / ml, a predominantly fungistatic effect of bifonazole is noted; for the fungicidal effect, a concentration of bifonazole of 20 μg / ml is required. Bifonazole is also active in relation to Corynebacterium minutissimum (MIC of 0.5 to 2 μg / ml), Gram-positive cocci, with the exception of enterococci (MIC of 4 to 16 μg / ml).

Resistant strains of fungi are very rare. Studies have not confirmed the development of secondary resistance in the primary sensitive strains.

Bifonazole inhibits the biosynthesis of ergosterol at two different levels, which distinguishes it from other antifungal agents and other azole derivatives. This double action leads to structural and functional damage to the cytoplasmic membrane of fungi.

Urea, the second active substance of the Ointment Mikospor® Set, performs keratoplastic function: softens the keratin of the infected nail and increases the penetration depth of bifonazole.

The combination of bifonazole with urea increases the antimycotic effect of the drug.

Pharmacokinetics:

When the ointment hits the affected skin, the absorption is 2-4% of the dose. When using Mikospora Ointment Set for the treatment of nails, the concentration of bifonazole in the blood plasma is always below the detection limit (ie <1ng / ml); accordingly, no systemic effects are observed.

Bifonazole penetrates the placental barrier in rats.

Indications:

Onychomycosis (non-surgical removal of finger-infected fingers and feet with fungal nails with simultaneous antimycotic action).

Contraindications:

Hypersensitivity to bifonazole or any component of the drug.

Pregnancy (first trimester).

Breastfeeding period.

Carefully:

Pregnancy (II and III trimesters) (see section "Use during pregnancy and during breastfeeding").

Children's age (see section "Method of administration and dose").

Use with caution in patients who are hypersensitive to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).

Pregnancy and lactation:

Pregnancy

Pre-clinical and pharmacokinetic data show that bifonazole and urea do not have any negative effect on the body of the mother and the fetus. Clinical studies in pregnant women have not been conducted. As a precaution, use of bifonazole and urea in the first trimester of pregnancy should be avoided.

In the second and third trimester of pregnancy, the use of the drug is possible if the potential benefit to the mother exceeds the possible risk to the fetus.

Breastfeeding period

It is not known whether the bifonazole and urea in breast milk in women.

Data from experimental animals show that bifonazole and its metabolites are excreted in breast milk.

If you need to use the drug Mikospor® Set during lactation, breastfeeding should be discontinued.

Fertility

The safety data obtained from preclinical studies suggest that the use of bifonazole does not have any negative effect on male and female fertility. The use of urea does not have a damaging effect on sperm, but there is no evidence of a possible effect on female fertility.

Dosing and Administration:

Outwardly. For adults and children, ointment is applied to the infected nail once a day in an amount sufficient to cover the entire surface of the nail with a thin layer. Then the processed nail is pasted with adhesive tape and left under the bandage for 24 hours, after which the bandage is changed.After removal of the patch, the treated surface is immersed in warm water for about 10 minutes and then carefully remove the softened part of the infected nail with a scraper.

Treated in this way, the nails are carefully dried, again applied to the ointment and sealed with a patch. Do not cover with ointment skin areas adjacent to the nail. In case of signs of irritation, the skin around the nail before applying the patch can be treated with zinc-containing paste.

Change bandages are produced every day. The treatment is continued until the softened nail plate infected with the fungus ceases to be removed by the scraper and the nail bed becomes smooth. This usually takes 7-14 days, depending on the extent of infection and the thickness of the nail.

The final antifungal therapy of the nail bed is performed with the help of the preparation Mycospor® cream for external application once a day for 4 weeks.

With more pronounced dystrophy of the nail plates, their removal with urea is more effective.

There were no separate studies in children. Based on the review of clinical data, no evidence of development

adverse effects of the drug in children. However, in children, the preparation Mikospor® should only be used under the supervision of a doctor.

If there is no improvement within 7 days or the condition worsens, you should consult your doctor.

Side effects:

Disturbances from the skin and subcutaneous tissues: contact dermatitis, maceration, desquamation, nail infections (local reactions on the part of the nail and nail bed - such as redness, irritation of the nail bed, the splitting of the nail plate), breach of nail pigmentation, erythema, skin irritation, itching, rash (including allergic) , pain in the place of application, pain in the limb.

Side effects are reversible and disappear after drug withdrawal.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

No risk of acute toxicity, as overdose (applying to extensive areas of skin under conditions conducive to absorption) after a single application of the drug to the skin or swallowed unlikely.

Interaction:

There are limited data on the possible interaction of bifonazole for external use and warfarin, leading to an increase in the international normalized relationship and possible bleeding and bruising. In the case of bifonazole in patients who are on warfarin therapy, careful monitoring of such patients is necessary.

Special instructions:

Use with caution in patients who are hypersensitive to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).

If symptoms persist / persist after discontinuation of treatment, you should consult your doctor.

Avoid contact with eyes.

Do not take internally.

Effect on the ability to drive transp. cf. and fur:

Mikospor®® The kit does not adversely affect the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).

Form release / dosage:

Ointment for external use.

Packaging:

For 10 g of ointment in an aluminum tube with a screwed plastic lid, 1 tube together with the instruction for medical use is placed in an individual cardboard package; a pack of ointment together with the packaging of the waterproof plaster, a scraper and instructions for applying the ointment are placed in a common cardboard pack.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013923 / 01

Date of registration:17.06.2008 / 06.10.2017

Expiration Date:Unlimited

The owner of the registration certificate:Bayer AGBayer AG Germany

Manufacturer: & nbsp

BAYER HealthCare, AG Germany

KERN PHARMA, S.L. Spain

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp07.06.2018

Illustrated instructions

Instructions

Mycospor® Set (Mycospor® ONYCHOSET)