Instructions for use Miconazole-Darnitsa cream 20 mg/g tube 15 g
Composition
active ingredient: miconazole;
1 g of cream contains miconazole nitrate 20 mg;
excipients: propylene glycol, macrogol 400, poloxamer, macrogol cetostearyl ether, cetostearyl alcohol.
Dosage form
Cream.
Main physicochemical properties: homogeneous white cream.
Pharmacotherapeutic group
Antifungal agents for topical use. Imidazole and triazole derivatives. ATX code D01A C02.
Pharmacological properties
Pharmacodynamics
The active substance of the drug - miconazole - belongs to the group of antifungal agents from the group of imidazole derivatives. Miconazole nitrate inhibits the biosynthesis of ergostyrene and changes the lipid composition of the membrane, which leads to the death of the fungal cell. It has a fungicidal effect on dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and yeast-like fungi (Candida albicans), as well as other pathogenic fungi (Malassezia furfur, Aspergillus niger, Penicillium crus-taceum). The drug also has an antibacterial effect, which is more pronounced against gram-positive bacteria (staphylococci, streptococci) and less pronounced against gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa, Proteus).
The drug has moderate hyperosmolar activity, as a result of which it exhibits an antiexudative effect.
Pharmacokinetics
When applied topically, miconazole is almost not absorbed into the systemic bloodstream. The small amount that is absorbed binds to plasma proteins (88.2%) and erythrocytes (10.6%). It is excreted from the body through the intestines in an unchanged state and in the form of metabolites.
Indication
Fungal infections of the skin and nails caused by dermatophytes or fungi of the genus Candida sensitive to miconazole; superinfections caused by gram-positive bacteria.
Contraindication
Hypersensitivity to the active substance or to any other components of the medicinal product.
Skin diseases caused by herpes viruses.
Interaction with other medicinal products and other types of interactions
When administered systemically, miconazole inhibits cytochrome P450 CYP3A4/2C9 and inhibits the metabolism of drugs metabolized by these enzymes. Due to limited systemic exposure, clinically significant interactions are rare. However, the drug should be used with caution simultaneously with oral anticoagulants (e.g. warfarin) and the anticoagulant effect should be monitored.
Also, when using miconazole simultaneously with hypoglycemic agents - urea derivatives or phenytoin - the effect of the latter may be enhanced.
Concomitant use of the drug with other topical forms of drugs is not recommended.
Application features
Avoid contact with eyes and open wounds.
If local reactions occur or there are no clinical manifestations of treatment effectiveness within 4 weeks, the use of the drug should be discontinued and additional examination should be performed.
The drug should be used with caution in patients with diabetes mellitus and impaired microcirculation.
If your nails are affected, it is recommended to cut them as short as possible.
When the feet are affected, it is recommended to pay special attention to the treatment of the interdigital spaces. Wearing loose, well-ventilated shoes and changing socks at least once a day is recommended.
Propylene glycol may cause skin irritation.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Use during pregnancy or breastfeeding
The drug may be used with caution during pregnancy after consulting a doctor.
It is not known whether miconazole passes into breast milk. If necessary, it is recommended to stop breastfeeding.
If breastfeeding, the medicine should not be applied to the mammary glands.
Method of administration and doses
The medicine should be applied topically.
Fungal skin infections: apply the medicine to the affected areas of the skin 2 times a day (morning and evening) and rub in until completely absorbed, covering a small area around the lesion. Wet areas in the folds (interdigital spaces, inguinal folds) should be washed and dried with a gauze napkin before applying the medicine.
The course of treatment depends on the effectiveness of the treatment and the results of mycological tests and ranges from 1 to 6 weeks. The average duration of candidiasis of the skin is 1–3 weeks, infections caused by dermatophytes - 3–4 weeks, and more prolonged infections - 5–6 weeks.
Fungal nail infections: after preliminary peeling of the affected nail plate, the drug is applied in a thin layer to the nail bed 1-2 times a day, followed by the application of an occlusive dressing. Treatment should be continued for at least 3 months until the final formation of a new nail.
Depending on the type and severity of the disease, the doctor may prescribe an individual dosage regimen and method of administration of the drug.
Children
The medicine is approved for use in pediatric practice only after consultation with a doctor.
Overdose
Skin irritation is possible, which usually resolves after discontinuation of the drug. In case of accidental ingestion of a large amount of the drug, gastric emptying is recommended.
The medicine is intended for external use only.
Adverse reactions
The following adverse reactions may develop:
Immune system: hypersensitivity reactions, including anaphylactic reactions, angioedema; Skin and subcutaneous tissue: rash, itching, erythema, dry skin, urticaria, contact dermatitis, application site reactions, including skin irritation, hyperemia, burning, tingling.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature of 8°C to 15°C.
Keep out of reach of children.
Packaging
15 g in a tube, 1 tube in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
