Medofliucon (fluconazole) capsules 50 mg. №7

Description

Medofliucon composition
active substance: fluconazole;
1 capsule contains fluconazole 50 mg;
excipients: lactose monohydrate; pregelatinized corn starch, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate; the capsule contains: patented blue V (E 131), titanium dioxide (E 171), gelatin.

Dosage form
Capsules.

Pharmacological properties
Antifungal drug intended for systemic use. The active agent of the drug is fluconazole, a triazole derivative, a powerful selective inhibitor of fungal enzymes that are necessary for the synthesis of ergosterol.
Lack of the latter affects the membranes of the fungal cell and is responsible for the antifungal activity of fluconazole.

Indications
It is prescribed for acute vaginal candidiasis, as well as for candidal balanitis, in cases where local therapy is inappropriate.
Also, the drug Medofliucon is used for:

• fungal infections of the skin caused by dermatophytes (trichophytosis of the skin, perineum, dermatophytosis);
• candidal infections of the mucous membranes (oropharynx, esophagus, mucocutaneous, non-invasive bronchopulmonary candidiasis, candiduria in immunocompromised patients);
• systemic candidiasis (candidemia, acute disseminated candidiasis, peritonitis) in patients without neutropenia;
• prevention of the development of candidiasis, in particular, in connection with bone marrow transplantation;
• acute cryptococcal meningitis in adults;
• chronic atrophic candidiasis, in particular, caused by the use of dentures;
• onychomycosis.

The drug Medofliucon is also prescribed as a prophylactic agent that prevents the development of:

• cryptococcus, including in HIV patients;
• candidiasis of the nasopharynx, esophagus;
• reducing the frequency of recurrence of vaginal candidiasis;
• candidiasis in neutropenic patients, including those receiving chemotherapy or stem cell transplantation.

The mechanism of action is due to the properties of fluconazole, a triazole derivative, which has the property of interfering with the normal functioning of the cell membranes of fungal cells, which ensures its antifungal activity.
Active against the most common Candida species. Also effective in the treatment of Cryptococcus neoformans, Cryptococcus gattii, as well as the endemic molds Blastomices dermatitidis, Coccidioides immitis, Histoplasma capsulatum and Paracoccidioides brasiliensis. C. krusei is resistant to it.

Contraindications
Contraindicated in case of allergy to fluconazole, other azole compounds, or to any of the active ingredients of the drug.
It is not used concomitantly with terfnadine (with a daily dose of fluconazole of 400 mg and above), as well as with drugs that prolong the QT interval, and which are metabolized by the CYP2A4 enzyme (in particular, with cisapride, astemizole, pimozide quinidine, amiodarone, erythromycin) …
Children should be used with caution, and only if the child is able to swallow the capsule (usually not earlier than 5 years).

Children
Efficacy and safety of the drug for the treatment of genital candidiasis in children have not been established, despite comprehensive data on the use of the drug in children. If there is an urgent need to use the drug in adolescents (aged 12 to 17 years), the usual doses for adults should be used.

Application during pregnancy and lactation
Application during pregnancy and lactation is possible only when the tangible positive effects for the body are higher than the likely harm caused.
It is not recommended to continue breastfeeding if high doses of fluconazole are needed.

Method of administration and dosage
Medofliucon is taken orally, regardless of food intake, without opening the capsule.
Most often, a single dose of 150 mg of the drug is enough to cure vaginal candidiasis in adults and children over 12 years old.
Average dosages for various fungal diseases:

• cryptococcal meningitis – 1 day – 400 mg, maintenance dose in the following days – 200-400 per day. Treatment lasts 6-8 weeks, if necessary even longer. If necessary, the dosage can be increased to 800 mg;
• coccidioidosis – 200-400 mg per day. The treatment lasts 1-2 years. In some cases, the dosage can be increased to 800 mg per day;
• invasive candidiasis – 800 mg on the first day. The maintenance dose is 400 mg per day. Duration of treatment – 2 weeks, it is possible to extend the course by the doctor’s decision;
• mucosal candidiasis (esophagus, candiduria) – 200-400 mg per day, maintenance dose – 100-200 mg. Treatment lasts 1-3 weeks, it is possible to extend the course by the doctor’s decision;
• chronic atrophic candidiasis – 50 mg per day for 2 weeks;
• chronic candidiasis of the skin and mucous membranes – 50-100 mg per day, up to 4 weeks, it is possible to extend the course by the doctor’s decision;
• prevention of mucosal candidiasis in patients with HIV – 100-200 mg per day or 200 mg 3 times a week. The duration of treatment is not limited;
• prevention of candidiasis in patients with neutropenia – 200-400 mg, treatment begins a week before the possible development of the disease;
• genital candidiasis – 150 mg once, recurrent (more often 4 times a year) – 150 mg every 3 days, in total 3 doses should be taken, after which 150 mg per day is taken 1 time per week for 6 months.

Dermatomycosis:

• mycoses of the feet, inguinal dermatomycosis, mycoses of the skin – 150 mg once a week or 50 mg once a day, 2-4 weeks, mycosis of the feet – 6 weeks;
• versicolor versicolor – 300-400 mg once a week, 1-3 weeks or 50 mg per day for 2-4 weeks;
• dermatophytic onychomycosis – 150 mg once a week until a new nail grows (3 to 12 months).

For children, dosages are often the same as for adults. The maximum daily dosage is 400 mg.
For mucosal candidiasis, invasive candidiasis, cryptococcal meningitis, for the prevention of meningitis, the dosage is calculated at the rate of 6-12 mg of fluconazole per 1 kg of patient weight.
For the prevention of candidiasis in children with HIV – 3-12 mg per 1 kg of patient weight.
Elderly patients and patients with renal insufficiency do not need dose adjustment.
If there are problems with the liver, then the drug should be used with caution.

Overdose
Excessive dosage causes hallucinations and paranoid behavior. Gastric lavage and treatment of symptoms are recommended.
Forced diuresis and hemodialysis will accelerate the elimination of the drug.

Side effects
The most common side effects are:

• headache, abdominal pain, diarrhea (diarrhea), nausea, vomiting, rash, loss of appetite, increased fatigue;
• anemia, agranulocytosis, neutropenia, thrombocytopenia;
• anaphylaxis, hypokalemia, insomnia, drowsiness, tremors, vertigo, myalgia, dermatitis, itching;
• cholestasis, jaundice, liver failure, hepatitis, hepatocellular necrosis.

Storage conditions and periods
Stored Medofliucon for up to 4 years at a temperature not exceeding 25 ° C.