Description
Trade name:
Fungican
Compound:
Each hard gelatin capsule contains:
Fluconazole 150 mg.
Excipients: microcrystalline cellulose, dibasic calcium phosphate, povidone K30, sodium croscarmellose, magnesium stearate, purified talc, gelatin, titanium dioxide.
Properties:
Fluconazole is an antifungal triazole. It is a potent and selective inhibitor of fungal enzymes required for ergosterol synthesis. It is active against opportunistic mycoses such as infections with Candida spp. including systemic candidiasis in immunocompromised animals; with Cryptococcus neoformans including intracranial infections; with Microsporum spp.; and with Trichophyton spp. Fluconazole is highly specific for fungal cytochrome P450-dependent enzymes. Fluconazole has been shown to have no effect on plasma testosterone concentrations in men or steroid concentrations in women of childbearing potential when given 50 mg daily for up to 28 days. No clinically significant effect was observed on endogenous steroid levels or on the ACTH-stimulated response in healthy male volunteers receiving fluconazole 200-400 mg daily. Interaction studies with antipyrine indicate that single or multiple doses of fluconazole 50 mg do not affect metabolism.
Indications:
For the treatment of cryptococcal meningitis, coccidioidomycosis, invasive candidiasis. Treatment of vaginal candidiasis, acute or recurrent; candidal balanitis when local therapy is not appropriate. For prophylaxis to reduce the recurrence rate of vaginal candidiasis (4 or more episodes per year). Prophylaxis of candidal infections in patients with prolonged neutropenia (e.g., in patients with hematological malignancies receiving chemotherapy or in patients receiving hematopoietic stem cell transplantation).
Method of administration and dosage:
The capsules should be swallowed whole and taken with or without food. The dosage should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple doses should be continued if clinical parameters or laboratory tests indicate that the active fungal infection has subsided. Inadequate treatment may result in relapse of the active infection. In adults:
Genital candidiasis: Acute vaginal candidiasis: 150 mg as a single dose. Candida balanitis single dose. Treatment and prevention of recurrent vaginal candidiasis 150 mg on three days for a total of 3 doses (days 1, 4 and 7), then 150 mg once a week maintenance dose. Maintenance dose: 6 months.
Dermatomycosis: athlete’s foot, ringworm, jock itch and candidal infections: 150 mg once a week for 2-4 weeks, athlete’s foot 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 out). Fingernails usually take 3 to 6 months to regrow, and toenails 6 to 12 months. Growth rates can vary greatly among individuals, depending on age.
Special populations: Elderly: The dosage should be adjusted according to renal function (Renal insufficiency: no adjustment required 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 according to hepatic insufficiency: there are limited data in patients with genital clearance and creatinine impairment, therefore fluconazole should be administered with caution to patients with liver dysfunction. Children: Safety and efficacy in genital candidiasis have not been established in children. If treatment of genital candidiasis is mandatory in adolescents (12 to 17 years), the dosage should be the same as in adults.
Contraindications:
Hypersensitivity to fluconazole, related azole compounds or any of the excipients in the composition. Fluconazole should not be taken concomitantly with terfenadine, cisapride or ergot derivatives.
Precautions:
With caution in patients with renal and hepatic dysfunction. The drug is associated with rare cases of serious liver toxicity. In cases of hepatotoxicity associated with fluconazole, no clear relationship was observed with the total daily dose, duration of therapy, gender or age of the patient. It is reversible upon discontinuation of therapy. The patient should be informed of the symptoms of serious liver effect (important asthenia, anorexia, persistent nausea, vomiting and jaundice). Treatment with fluconazole should be stopped immediately and the patient should consult a doctor.
Cardiovascular system: Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Concomitant use of fluconazole and halofantrine is not recommended.
Dermatological reactions: Patients have rarely developed skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrosis during treatment with fluconazole. Hypersensitivity: Anaphylaxis has been reported in rare cases.
Terfenadine: Co-administration of fluconazole at doses below 400 mg daily with terfenadine should be carefully monitored.
Because this medicine contains lactose, patients with rare hereditary problems of galactose intolerance or glucose-galactose malabsorption should not take this medicine.
Side effects:
Most common: headache, abdominal pain, diarrhea, nausea, vomiting, alkaline phosphatase increased and rash. Blood and lymphatic system disorders: anemia. Rare: agranulocytosis, leukopenia, thrombocytopenia, neutropenia. Immune system disorders: rare: anaphylaxis. Metabolism and nutrition disorders: uncommon: decreased appetite. Rare: hypercholesterolemia, hypertriglyceridemia, hypokalemia. Psychiatric disorders: drowsiness, insomnia. Nervous system disorders: uncommon: convulsions, paresthesia, dizziness, taste perversion. Rare: tremor. Gastrointestinal disorders: uncommon: constipation, dyspepsia, flatulence, dry mouth. Rare: liver failure, hepatocellular necrosis, hepatitis, hepatocellular injury. Skin and subcutaneous tissue disorders: common: rash. Uncommon: drug rash, urticaria, pruritus, increased sweating. Rare: angioedema, facial oedema, alopecia. Musculoskeletal and connective tissue disorders: uncommon: myalgia. General disorders: fatigue, malaise, asthenia, fever.
Pregnancy and lactation: A study showed that women who received fluconazole in the first trimester of pregnancy had an increased risk of spontaneous abortion. There have been reports of multiple congenital anomalies in children whose mothers were treated for at least 3 months or more with high doses (400-800 mg daily amount of fuconazole for coccidioidomycosis. The relationship between the use of fuconazole and these events is limited to the use of fluconazole in standard doses and for short-term treatment). Do not use during pregnancy unless clearly needed and after consultation with a physician.
Fluconazole passes into breast milk. Breastfeeding can be maintained after a single standard dose of fluconazole 200 mg or less. Not recommended after repeated use or after taking a large dose of fluconazole.
Effects on ability to drive and use machines: Patients should be warned of the possibility of dizziness or seizures while taking fluconazole and should not be advised to drive machines due to these obvious side effects.
Storage method:
Store at a temperature not exceeding 30 degrees in a dry place, out of reach of children.
Package:
The cardboard box contains 2 blisters with 1 capsule each and paper instructions.
