Instructions for use Mikogel gel 20 mg/g tube 15 g
Composition
active ingredient: miconazole;
1 g of gel contains miconazole nitrate in terms of 100% substance – 20 mg;
excipients: carbomer, glycerin, propylene glycol, ammonia solution 15%, ethanol 96%, polysorbate, mineral oil, formaldehyde solution, purified water.
Dosage form
Gel.
Main physicochemical properties: white or white gel with a slightly yellowish tint, uniform in consistency, with a faint specific odor.
Pharmacotherapeutic group
Antifungal drugs for topical use. Imidazole and triazole derivatives. ATX code D01A C02.
Pharmacological properties
Pharmacodynamics
Mycogel® is an antifungal and antibacterial agent.
The active substance of the drug - miconazole nitrate - inhibits the biosynthesis of ergosterol and changes the lipid composition of the membrane, causing the death of the fungal cell. A pronounced antifungal effect is manifested against dermatophytes (Microsporum canis, Trichophyton rubrum, Epidermophyton floccosum), fungi of the genus Candida, Cryptococcus and some others, as well as fungi of the genus Aspergillus. It exhibits antibacterial activity against gram-positive microorganisms (mainly staphylococci) and to a lesser extent - against gram-negative bacteria.
Pharmacokinetics
It is practically not absorbed through intact skin; the concentration of miconazole in blood plasma is minimal when applied topically.
Indication
Skin and nail infections caused by dermatophytes or fungi of the genus Candida sensitive to miconazole. Superinfection caused by gram-positive microorganisms.
Contraindication
Hypersensitivity to miconazole nitrate and/or to any of the other ingredients of the drug. Skin diseases caused by herpes viruses.
Interaction with other medicinal products and other types of interactions
It is not recommended to use the drug simultaneously with other ointments.
It has been noted that miconazole inhibits CYP3A4/2C9 when administered systemically. Due to limited systemic availability, clinically significant interactions are rarely observed with topical administration. Thus, the available information on a possible increase in the activity of hypoglycemic drugs - sulfourea derivatives and phenytoin when used concomitantly with miconazole is not clinically significant.
However, if the patient is taking oral anticoagulants such as warfarin, caution should be exercised and the prothrombin index should be monitored.
Application features
Avoid contact with eyes and open wounds.
Use with caution in cases of microcirculation disorders and diabetes.
If your nails are affected, they should be cut as short as possible.
If the foot is affected, it is necessary to carefully treat the spaces between the toes, wear loose, well-ventilated shoes and change socks daily.
If an allergic reaction develops, it is necessary to stop taking the drug.
The presence of propylene glycol may cause skin irritation.
The presence of formaldehyde in the solution may cause local skin reactions (e.g. contact dermatitis).
Ability to influence reaction speed when driving vehicles or other mechanisms
No messages.
Use during pregnancy or breastfeeding
External use of the drug during pregnancy is possible, but requires caution (after consulting a doctor).
When used externally, women are recommended to stop breastfeeding for the period of treatment.
Method of administration and doses
Adults and children should apply Mikogel® to the affected areas of the skin (without rubbing) with a thin layer 2 times a day. If necessary, apply under an occlusive dressing.
The course of treatment depends on the effectiveness of the treatment and the results of mycological tests, and is from 1 to 6 weeks. The average duration of treatment for candidiasis of the skin is 1–3 weeks, infections caused by dermatophytes – 3–4 weeks, more protracted infections – 5–6 weeks. After the disappearance of clinical symptoms of the disease, the use of the drug should be continued for at least 1 more week.
When treating onychomycosis, after preliminary peeling of the affected nail plate, apply the gel in a thin layer to the nail bed 1–2 times a day. Treatment should be carried out continuously for at least 3 months until the final formation of a new nail.
Children
The drug is approved for use in children from birth after consulting a doctor.
Overdose
Due to the lack of systemic absorption, no cases of overdose have been reported. Symptoms of overdose may include skin irritation, which usually disappear after discontinuation of the drug.
The drug is intended for cutaneous application only. In case of accidental ingestion of large quantities of the drug, an appropriate method of gastric emptying should be used.
Adverse reactions
The drug is well tolerated in most cases.
Skin and subcutaneous tissue disorders: application site reactions, including redness, irritation, burning, rash, itching, dry skin; contact dermatitis;
Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, anaphylactic reactions.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature of 2°C to 8°C.
Keep out of reach of children.
Packaging
15 g in a tube, 1 tube in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Kyivmedpreparat",
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
