Treflucan 150 mg 1 capsule

Tradename:

Treflucan

Treflucan

Composition:

Each capsule contains:

Fluconazole 150mg

Auxiliary components:

lactose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate.

Properties:

Fluconazole is a triazole antifungal agent. Its main mode of action is to inhibit the synthesis of sterols in the fungal cell. Fluconazole has a high specificity in relation to fungal enzymes dependent on cytochrome P-450. Blocks the conversion of lanosterol of fungal cells into a membrane lipid – ergosterol; increases the permeability of the cell membrane, disrupts growth and replication. Fluconazole, being highly selective for cytochrome P450 of fungi, practically does not inhibit these enzymes in

the human body (in comparison with itraconazole, clotrimazole, econazole and ketoconazole, it suppresses oxidative processes in human liver microsomes to a lesser extent, dependent on cytochrome p450).

Indications:

For adults for treatment – vaginal candidiasis, acute or recurrent; candidal balanitis when local therapy is not appropriate.

Dermatomycosis, including foot fungus, ringworm, inguinal fungus, pityriasis versicolor, and candidal skin infections when systemic therapy is indicated. Onychomycosis when other agents are not considered suitable. To prevent a decrease in the frequency of relapses of vaginal candidiasis (4 or more episodes per year). Prevention of candidal infections in patients with long-term neutropenia (for example, in patients with hematologic malignancies receiving chemotherapy or in patients receiving hematopoietic stem cell transplantation).

Mode of application:

The capsules should be swallowed whole a taken with or without food. The dose should

be based on the nature and severity of the fungal infection. Treatment for multiple-dose infections should be continued if clinical parameters or laboratory tests indicate that the active fungal infection has subsided. An inadequate treatment period can lead to a relapse of active infection. In adults:

Genital candidiasis: Acute vaginal candidiasis: 150 mg as a single dose. Shaped balanitis single dose. Treatment and prevention of recurrent vaginal candidiasis 150 mg in three days for a total of 3 doses (days 1, 4 and 7), followed by 150 mg once a week with a maintenance dose. Maintenance dose: 6 months.

Dermatomycosis: foot fungus, ringworm, inguinal fungus and candidal infections: 150 mg once a week for 2-4 weeks, foot fungus may require treatment for up to 6 weeks. Pityriasis versicolor: 300-400 mg once a week for 1-3 weeks. Onychomycosis: 150 mg once a week. Treatment should be continued until the infected nail is replaced (an uninfected nail grows). Restoration of fingernails usually takes 3 to 6 months and on toenails 6 to 12 mont The growth rate of different people can var greatly with age. After successful treatment of

long-term chronic infections, the nails are sometimes disfigured.

Special populations: Elderly: Dosage should be adjusted based on renal function (see Table: Renal Failure: No Adjustment Needed With Single Therapy). Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on dialysis days, patients should receive a reduced dose in accordance with hepatic impairment: there are limited data in patients with genital clearance and creatinine impairment, therefore, fluconazole should be prescribed with caution in patients with liver dysfunction. Children: Safety and efficacy for genital candidiasis in children has not been established. If treatment of genital candidiasis is mandatory for adolescents (12 to 17 years old), then the dosage should be the same as in adults.

Contraindications:

Hypersensitivity to fluconazole or related azole compounds or any of the other ingredients in the formulation.

Precautions:

Use caution in patients with renal and hepatic dysfunction. Treflucan has been associated with rare cases of severe liver toxicity. In cases of hepatotoxicity associated with fluconazole, there was no clear relationship with the total daily dose, duration of therapy, gender or age of the patient. It is reversible when the therapy is stopped. The patient should be informed of the symptoms of a serious hepatic effect (asthenia, anorexia, persistent nausea, vomiting and jaundice are important).

Fluconazole treatment should be discontinued immediately and the patient should see a doctor.

Cardiovascular: Several azoles, including fluconazole, have been associated with prolongation of the QT interval on an electrocardiogram. Simultaneous administration of fluconazole and halofantrine is not recommended.

Dermatologic reactions: Patients rarely develop skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrosis during treatment with fluconazole. Hypersensitivity: In rare cases, anaphylaxis has been reported.

Terfenadine: Coadministration of fluconazole at doses below 400 mg per day with terfenadine

should be closely monitored.

Since the drug contains lactose, patients with rare hereditary problems of galactose intolerance or glucose-galactose malabsorption should not take this medication.

Side effects:

Most common: headache, abdominal pain, diarrhea, nausea, vomiting, elevated alkaline phosphatase levels, and rash. Diseases of the blood and lymphatic system: anemia. Rarely: agranulocytosis, leukopenia, thrombocytopenia, neutropenia. Immune system disorders: rare anaphylaxis. Metabolism and nutritional disorders: infrequently: decreased appetite. Rarely:

hypercholesterolemia, hypertriglyceridemia, hypokalemia. Mental disorders: drowsiness, insomnia. Nervous system disorders: infrequently: convulsions, paresthesia, dizziness, taste perversion. Rare: tremor. Gastrointestinal disorders: infrequently:

constipation, dyspepsia, flatulence, dry mouth. Rare: liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage. Diseases the skin and subcutaneous tissue: general: rash. Uncommon: drug rash, urticaria, itching, increased sweating. Rare: anqioedema, facial

edema, alopecia. Musculoskeletal system and connective tissue: infrequently: myalgia. General disorders: fatigue, malaise, asthenia, fever.

Pregnancy and lactation:

Data from several hundred pregnant women who received standard doses (<200 mg / day) of fluconazole, given as a single or multiple dose in the first trimester, show no undesirable fetal defects. Despite this, the use of the drug in pregnant women is inappropriate, with the exception of severe or life-threatening forms of fungal infections, when the potential benefit from the use of fluconazole to the mother significantly outweighs the risk to the fetus.

Fluconazole passes into breast milk.

Breastfeeding can be maintained after a single dose of 200 mg or less of a standard dose of fluconazole. Not recommended after repeated use or after taking a large dose of fluconazole.

Impact on ability to drive: Patients should be warned of the possibility of dizziness or seizures while taking Treflucan, and they ar not advised to drive and operate cars if the symptoms occur.

Storage:

Store at 25C in a dry place out of reach of children.

Packaging:

The cardboard box contains a blister with 1 capsule and paper instructions.