Diflucan

Trade name:

Diflucan

Compound:

Each capsule contains:

Fluconazole 150 mg.

Excipients: lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate.

Properties:

Fluconazole – has the property of effectively suppressing the synthesis of sterols in fungal cells. The effectiveness of Diflucan has been proven against yeast and yeast-like fungi (Candida spp, Cryptococcus neoformans), mold fungi (Histoplasma capsulatum, Blastomyces dermatitides), dermatophytes (Trichophyton spp, Microsporum spp), dimorphic forms (Coccidioides immitis).

Indications:

Cryptococcosis, including cryptococcal meningitis and infections of other localizations (e.g. lungs, skin), including in patients with a normal immune response and in AIDS patients, organ transplant recipients and patients with other forms of immunodeficiency; maintenance therapy for the prevention of relapses of cryptococcosis in AIDS patients. Generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infection, such as infections of the peritoneum, endocardium, eyes, respiratory and urinary tracts, including in patients with malignant tumors, in intensive care units and receiving cytotoxic or immunosuppressive agents, as well as in patients with other factors predisposing to the development of candidiasis.

Candidiasis of the mucous membranes, including the mucous membranes of the oral cavity and pharynx, esophagus, non-invasive bronchopulmonary infections, candiduria, cutaneous and mucosal and chronic atrophic candidiasis of the oral cavity (associated with wearing dentures), including in patients with normal and suppressed immune function. Prevention of relapse of oropharyngeal candidiasis in patients with AIDS.

Genital candidiasis; acute or recurrent vaginal candidiasis; prophylaxis to reduce the frequency of recurrences of vaginal candidiasis (4 or more episodes per year); candidal balanitis. Prophylaxis of fungal infections in patients with malignant tumors predisposed to such infections as a result of cytotoxic chemotherapy or radiation therapy.

Mycoses of the skin, including mycoses of the feet, body, inguinal region, versicolor lichen, onychomycosis and cutaneous candidal infections; deep endemic mycoses in patients with normal immunity, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis.

Method of administration and dosage:

Diflucan is taken orally. The capsules must be swallowed whole and regardless of food intake.

The dosage is adjusted according to the type and severity of the fungal infection. Treatment of infections that require multiple doses should be continued until clinical signs or laboratory tests indicate that the active fungal infection has been controlled. Insufficient treatment may result in relapse of the active infection.

Use in adults. Treatment of cryptococcal meningitis: the daily dose is 400 mg on the first day, followed by 200-400 mg per day for 6 to 8 weeks. In cases of treatment of life-threatening infections, the daily dose can be increased to 800 mg. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with a high risk of relapse: 200 mg per day for a period of time determined by the attending physician.

Coccidioidomycosis: 200-400 mg for 11-24 months or longer, depending on the patient’s condition. For some infections, especially those involving the meninges, a dose of 800 mg daily may be considered.

Invasive candidiasis: loading dose is 800 mg on day 1, followed by 400 mg daily. The general recommendation for the duration of treatment for candidemia is 2 weeks after the first negative result for the presence of candidemia in the patient’s blood and complete disappearance of candidemia symptoms.

Treatment of mucosal candidiasis. Oropharyngeal candidiasis: the daily dose is 200-400 mg on the first day, followed by 100-200 mg per day for 7-21 days (until remission of oropharyngeal candidiasis is achieved). In patients with severe immune system dysfunction, longer periods of therapy can be used.

Esophageal candidiasis: The daily dose is 200-400 mg on the first day, followed by 100-200 mg per day for 14-30 days (until remission of esophageal candidiasis is achieved). In patients with severe immune system dysfunction, longer periods of therapy can be used.

Candiduria: 200-400 mg daily for 7-21 days. In patients with severe immune system dysfunction, longer periods of therapy may be used.

Chronic atrophic candidiasis: 50 mg daily for 14 days.

Chronic mucocutaneous candidiasis: 50-100 mg daily for up to 28 days. Depending on the severity of the infection or the concomitant immune dysfunction and infection, longer periods of therapy may be used.

Prevention of recurrence of mucosal candidiasis in HIV-infected patients at high risk of recurrence. Oropharyngeal candidiasis: 100-200 mg daily or 200 mg 3 times a week for the period of time determined by the treating physician in chronically immunocompromised patients. Esophageal candidiasis: 100-200 mg daily or 200 mg 3 times a week for the period of time determined by the treating physician in chronically immunocompromised patients.

Genital candidiasis. Acute vaginal candidiasis: 150 mg as a single dose. Candidal balanitis: 150 mg as a single dose. Treatment and prevention of recurrent vaginal candidiasis (4 or more episodes per year): 150 mg every three days for a total of 3 doses (on days 1, 4 and 7), then a maintenance dose of 150 mg once a week for 6 months.

Dermatomycosis. Tinea pedis, tinea corporis, tinea cruris, candidiasis: 150 mg once a week or 50 mg once a day for 2 to 4 weeks, but for tinea pedis, therapy for up to 6 weeks may be required.

Pityriasis versicolor: 300-400 mg once a week for 1-3 weeks or 50 mg once a day for 2-4 weeks.

Tinea capitis (onychomycosis): 150 mg once weekly. Treatment should be continued until the infected nail is replaced (an uninfected nail grows out). Fingernails and toenails usually take 3 to 6 months and 6 to 12 months to regrow. However, the rate of growth may vary considerably from person to person and with age. In some cases, nails remain deformed after successful treatment of a long-standing chronic infection.

Prophylaxis of Candida infections in patients with prolonged neutropenia: 200-400 mg. Treatment should be started several days before the expected onset of neutropenia and continued for 7 days after the neutrophil count exceeds 1000 cells/mm3.

Elderly patients. In the absence of signs of renal impairment, the drug is administered in the usual dose. Renal impairment: no dose adjustment is required for a single dose. Patients (including pediatric patients) with renal impairment should initially receive a loading dose of 50 mg to 400 mg (based on the recommended daily dose for the indication) when using the drug multiple times.

Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.

Impaired liver function. There are limited data on the use of Diflucan in patients with impaired liver function, so this drug should be used with caution in such patients.

Paediatric patients: In paediatric patients, the maximum dose of 400 mg per day should not be exceeded.

As with similar infections in adults, the duration of therapy is determined by the clinical and mycological response. Diflucan is administered as a single daily dose.

Contraindications:

Hypersensitivity to fluconazole, related azole compounds or any of the excipients in the composition. Fluconazole should not be taken simultaneously with derivatives of terfenadine, cisapride or ergot. The period of pregnancy and lactation.

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.

Pregnancy and lactation: Data from several hundred pregnant women receiving standard doses (<200 mg/day) of fluconazole, administered as single or multiple doses in the first trimester, show no adverse fetal effects. However, use of the drug in pregnant women is not advisable, except in cases of severe or life-threatening fungal infections, when the potential benefit to the mother greatly outweighs the risk to the fetus.

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 about the possibility of dizziness or seizures while taking fluconazole and should not be advised to drive machines because of these obvious side effects.

Side effects:

From the gastrointestinal tract: decreased appetite, nausea, constipation or diarrhea, flatulence, abdominal pain, toothache, rarely – liver dysfunction (scleral icterus, jaundice, hyperbilirubinemia, increased activity of ALT, AST and alkaline phosphatase). From the nervous system: headache, dizziness, excessive fatigue, rarely – convulsions. From the hematopoietic organs: rarely – leukopenia, thrombocytopenia (bleeding, petechiae), neutropenia, agranulocytosis. Allergic reactions: skin rash, rarely – erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylactoid reactions. Others: rarely – renal dysfunction, alopecia, hypercholesterolemia, hypertriglyceridemia, hypokalemia.

Storage method:

Store at a temperature not exceeding 30 degrees out of reach of children.

Package:

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