Mycobactovir^® (Capsules, Cream) Instructions for Use

ATC Code

J02AX (Other systemic antifungal drugs)

Clinical-Pharmacological Group

Antifungal drug

Pharmacotherapeutic Group

Other systemic antifungal drugs

Pharmacological Action

The mechanism of action of the active substance – sodium 5-[(3′,5′-dichloro-2′-hydroxybenzylidene)amino]-6-methyl-2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-ide – is associated with the specific suppression of the synthesis of β-1,6-glucan in the fungal cell wall, disrupting its structure, leading to fungal death. It has a fungicidal effect.

It is active against dermatophytes, molds, and some dimorphic fungi, as well as yeast fungi.

In vivo, it is active against Trichophyton spp., Epidermophyton spp., Pityrosporum spp., Candida albicans.

In vitro, the specific activity of the agent has been demonstrated against fungal strains: Aspergillus spp., Mucor spp., Trichophyton spp., Candida spp including C.albicans, C.auris, C.glabrata, C.parapsilosis, C.stellatoidea, C.dusitaniae, C.candidum, C.krusei, C. dubliniensis, as well as Cryptococcus neoformans, Geotrichum candidum, Saccharomyces cerevisiae, Malassezia furfur, Pneumocystis carinii and P. murina, as well as Microsporum canis spp, Epidermophyton floccosum spp, Paecilomyces variotii spp, Histoplasma capsulatum.

The minimum inhibitory concentration of the active substance is 0.125-1.0 µg/ml.

Pharmacokinetics

After oral administration at a daily dose of 1200 mg repeatedly, C_max is 1 mg/l, T_max is 1.5-3 hours. AUC is 5.9 mg x h/l. The total mean residence time of the drug in the body (MRT indicator) is about 6-7.5 hours. Plasma concentration is linearly dependent on the dose.

The metabolic pathways are unknown. It is completely metabolized and excreted in the form of two main metabolites: 6-methyluracil and 3,5-dichlorosalicylaldehyde. It is not a substrate for the CYP1A2 isoenzyme. It is excreted mainly by the kidneys as metabolites. T_1/2 is 4-5 hours. No accumulation was detected during course use.

With topical application, systemic absorption is less than 5% of the dose.

Indications

For oral administration

Candidal vulvovaginitis in adults (when azoles are ineffective or intolerable), when local therapy is not applicable.

For topical application

Tinea pedis, tinea cruris, tinea corporis caused by susceptible microorganisms.

ICD codes

Dosage Regimen

Determine the dosage individually based on the indication, route of administration, and patient presentation.

For oral administration using capsules: Administer a total daily dose of 1200 mg. Divide this dose into two equal intakes of 600 mg each, taken approximately every 12 hours.

Complete the full treatment course of 6 days for oral therapy, even if symptoms improve earlier.

For topical application using the cream: Apply a thin layer of cream to cover the affected skin areas and immediately surrounding area.

Use the cream twice daily, typically in the morning and evening. Gently rub in until absorbed.

Continue topical treatment for 7 to 14 days as directed. The duration depends on the infection site and clinical response.

Wash hands before and after applying the cream, unless the hands are the treatment site.

Do not use occlusive dressings or wraps over the cream unless specifically instructed by a physician.

If no clinical improvement is observed after one week of topical therapy, re-evaluate the diagnosis.

Adhere strictly to the prescribed dosage form, frequency, and treatment duration. Do not exceed the recommended course.

Adverse Reactions

From the hematopoietic system lymphocytosis, monocytosis, leukopenia, thrombocytopenia, eosinophilia, lymphopenia.

From the nervous system headache, dizziness, asthenic syndrome.

From the digestive system: dyspepsia, nausea, lower abdominal pain.

From the cardiovascular system: impaired repolarization processes (prolonged QT interval on ECG).

From the liver and biliary tract hyperbilirubinemia, increased ALT and AST activity.

From the urinary system: frequent urination, polyuria, increased creatinine concentration, increased CPK activity.

From the skin and subcutaneous tissues: with topical application, an allergic reaction in the form of redness, itching or burning sensation at the application site is possible.

Other: hyperglycemia.

Contraindications

Hypersensitivity to the drug; age under 18 years; pregnancy, breastfeeding period.

For oral administration: renal and hepatic insufficiency.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Effect on ability to drive vehicles and operate machinery

Patients should be warned about the possibility of dizziness during the use of the drug; if dizziness occurs, refrain from activities requiring increased attention and rapid reactions.

If there is no effect after 1 week of treatment with topical application of the drug, the diagnosis should be clarified.

If the topical application of the drug gets into the eyes, rinse them with running water.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.