Mycospor set for the treatment of nails ointment + leukopl. + Scraper
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Active ingredients
Bifonazole + Urea
Release form
Ointment
Composition
1 ml of solution contains: active substance: mitoxantrone hydrochloride 2.328 mg equivalent to mitoxantrone 2.000 mg excipients: sodium chloride, sodium acetate, glacial acetic acid, water for injection.
Pharmacological effect
Bifonazole, the first active ingredient in the Myosporus Ointment Kit, is an imidazole derivative and has a broad spectrum of antimycotic action. Bifonazole has a fungicidal action against dermatophytes (in particular, against Trichophyton spp.). The full fungicidal effect is achieved at a bifonazole concentration of 5 μg / ml and a duration of exposure of at least 6 hours. Bifonazole has a fungistatic effect on yeast and mold fungi, as well as Malassezia furfur. With the defeat of yeast fungi, for example, Candida spp., At a concentration of 1-4 μg / ml, the fungistatic effect of bifonazole is predominantly observed; For the fungicidal effect, a bifonazole concentration of 20 mcg / ml is required. Bifonazole is also active against Corynebacterium minutissimum (MIC 0.5-2 mcg / ml), gram-positive cocci, with the exception of enterococci (MIC 4-16 mcg / ml). Resistant strains of fungi are very rare. Studies have not confirmed the development of secondary resistance in primary sensitive strains. Bifonazole inhibits ergosterol biosynthesis at two different levels, which distinguishes it from other antifungal drugs and other azole derivatives. This double action leads to structural and functional damage to the cytoplasmic membrane of fungi. Urea, the second active ingredient in the Mycospor Kit ointment, performs a keratoplastic function: it softens the keratin of an infected nail and increases the depth of penetration of bifonazole. The combination of bifonazol with urea enhances the antimycotic effect of the drug.
Pharmacokinetics
If the ointment gets on the affected skin, the absorption is 2-4% of the drug dose. When applying the Microspor Ointment Kit for the treatment of nails, the concentration of bifonazole in the blood plasma is always below the limit of detection (ie. <1ng / ml); accordingly, no systemic effects are observed. Bifonazole crosses the placental barrier in rats.
Indications
Onychomycosis (non-surgical removal of fungus-affected fingernails and toenails with simultaneous antimycotic action).
Contraindications
- pregnancy (I term); - Hypersensitivity to bifonazole or any other component of the drug. With care: pregnancy (II and III trimesters) and the lactation period, children's age.
Precautionary measures
Pregnancy (II and III trimesters) (see section Use during pregnancy and during breastfeeding). Baby age. Use with caution in patients who have an increased sensitivity to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole) .
Use during pregnancy and lactation
Pregnancy The data of preclinical and pharmacokinetic studies show that bifonazole and urea do not have any negative effect on the mother and fetus. Clinical studies in pregnant women were not conducted. As a precautionary measure, the use of bifonazole and urea in the first trimester of pregnancy should be avoided. In the II and III 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 bifonazole and urea penetrate into breast milk in women. The data obtained in experimental animals show that bifonazole and its metabolites are excreted in breast milk. If necessary, the use of the drug Mycospor Set during lactation breastfeeding should be discontinued. Fertility 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 data on the possible effect on female fertility are not available.
Dosage and administration
Outwardly. For adults and children, the ointment is applied on an infected nail once a day in an amount sufficient to cover the entire surface of the nail with a thin layer. Then, the treated nail is sealed with a plaster and left under the dressing for 24 hours, after which the dressing is changed.After removing the patch, the treated surface is immersed in warm water for about 10 minutes and then the softened part of the infected nail is carefully removed with a scraper. The nails treated in this way are thoroughly dried, ointment is applied again and sealed with a plaster. Do not cover with ointment the skin adjacent to the nail. In case of signs of irritation, the skin around the nail can be treated with a zinc-containing paste before applying the patch. Change dressings produced every day. The treatment is continued until the softened nail plate infected with the fungus is no longer removed by the scraper and the nail bed becomes smooth. It usually takes 7-14 days, depending on the extent of the infection and the thickness of the nail. Carry out the final antifungal therapy of the nail bed with the help of the drug Mycospor cream for external use 1 time per day for 4 weeks. With more severe dystrophy of the nail plates, their removal with urea is more effective. Separate studies in children was not conducted. Based on a review of clinical data, no evidence of the development of adverse side effects when using the drug in children. However, in children, the drug Mycospor Set should be used only under the supervision of a physician. If there is no improvement within 7 days or the condition has worsened, it is necessary to consult a doctor.
Side effects
Violations of the skin and subcutaneous tissues: contact dermatitis, maceration, desquamation, nail lesions (local reactions from the nail and nail bed - such as redness, irritation of the nail bed, splitting of the nail plate), impaired pigmentation of the nail, erythema, skin irritation, itching , rash (including allergic), pain at the site of application, pain in the limb. Side effects are reversible and disappear after drug withdrawal. If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects not indicated in the instruction, inform your doctor.
Overdose
The risk of acute intoxication is absent, as overdosing (application to large areas of skin under conditions favorable for absorption) is unlikely after a single application of the drug to the skin or accidental ingestion.
Interaction with other drugs
The absorption of bifonazol when externally administered is insignificant. Cases of interaction with other drugs are unknown.
special instructions
Use with caution in patients who have an increased sensitivity to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole). The success of treatment largely depends on the thoroughness of the removal of the affected areas of the nail and the subsequent treatment of the nail bed with Mycospor cream. In very rare cases, an allergic reaction to the patch may occur. In the event of such an allergic reaction, you should consult with your doctor and use a different type of plaster or rubber fingertips.