Fluconazole 150 mg. 3 capsules

TEVA
Fluconazole 150 mg. 3 capsules
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ACTION

Fluconazole is an oral broad spectrum synthetic antimycotic agent that stops the transformation of the fungal cell lysterol into a membrane lipid ergosterol. As a result, it increases the permeability of the cell membrane and inhibits growth and reproduction. Fluconazole is very rarely observed.

INDICATIONS

• Cryptococcal disease, including cryptococcal meningitis with different localization (pulmonary, dermal); in patients with normal immune system, as well as in AIDS-infected organ transplants and other causes of immune suppression. It is also used as a supportive therapy to prevent recurrence of cryptococcal disease in AIDS patients.

Systemic candidiasis, incl. candidiasis, disseminated candidiasis, or other forms of invasive candidiasis infection - candidiasis peritonitis, endocarditis, eye infections, pulmonary and uroinfections; in patients with malignancies receiving cytotoxic and immunosuppressive therapy in patients who have other predisposing factors for candidiasis infections.

• Mucosal candidiasis - oropharyngeal, esophageal candidiasis, non-invasive bronchopulmonary candidiasis, candida, cutaneous and chronic atrophic candidiasis of the oral mucosa (for patients with dentures); in patients with nerve defenses and immunocompromised patients; to prevent recurrence of oropharyngeal candidiasis in AIDS patients.

• Genital candidiasis - acute and recurrent vaginal candidiasis as well as prophylaxis of relapses (three or more episodes of the year); Candidate balanitis.

• Prophylaxis of mycotic infections in patients with malignant diseases predisposed to such infections due to cytotoxic chemotherapy or radiotherapy.

• Dermatomycoses including tinea pedis, tinea corporis, tinea cruris, tinea versicolor, tinea unguium (onychomycosis); skin candidiasis.

• Deep endemic mycoses - in immunocompromised patients, coccidioidomycosis, paracoccidioidomycosis, sporothytrosis and histoplasmosis.

INFORMATION NEEDED BEFORE USING THE MEDICINAL PRODUCT

CONTRAINDICATIONS
Fluconazole is contraindicated in patients with hypersensitivity to Fluconazole or other azoles or to some of the excipients included in the dosage form.

SPECIAL PRECAUTIONS FOR USE

Patients receiving rash during treatment with fluconazole should be closely monitored, and treatment with the product should be discontinued as the skin changes progress.

MEDICINAL AND OTHER INTERACTIONS

When concomitant administration of fluconazole and oral sulphonylureas, blood glucose concentration should be monitored and, if necessary, co-administration of fluconazole with coumarin-type anticoagulants should be carefully monitored for prothrombin time due to the danger of prolongation.

Concomitant administration of ciclosporin and fluconazole may increase the serum concentration of ciclosporin.

It is not possible to combine the product with cisapride due to a high risk of severe heart rhythm disturbances.

Note that the metabolism of Fluconazole is increased with concomitant administration of rifampicin, which requires an increase in its dose. When co-administered with cimetidine, the serum concentration of fluconazole decreases and hydrochlorothiazide is increased. Concomitant administration of fluconazole with warfarin leads to prolongation of prothrombin time. Fouliconol increases the half-life of theophylline, tolbutamine, zidovudine and phenytoin, requiring observation over time of their combined application.
WARNINGS FOR SPECIAL GROUPS OF PATIENTS

Although Fluconazole is rarely associated with hepatotoxicity, patients who show altered liver function tests during treatment with Fluconazole should be screened for severe hepatic impairment. Treatment should be discontinued if there are symptoms of developing liver diseases that may be associated with it.

APPLICATION FOR PREGNANCY AND BREASTING PERIOD

Use during pregnancy and lactation is not recommended unless specifically instructed by the attending physician. Fluconazole is excreted in breast milk at concentrations close to plasma and, therefore, when breast-feeding is necessary, breast-feeding should be temporarily discontinued.

IMPACT ON DRIVING AND MACHINING FUCONZOLE does not affect the ability to drive or use machines.
DATA ABOUT SUPPORT SUBSTANCES

The product contains lactose as an excipient. Not suitable for people with lactase deficiency, galactose, or glucose / galactose malabsorption syndrome.

INFORMATION FOR CORRECT USE

DOSAGE AND ROUTE OF ADMINISTRATION

By doctor's prescription!
Adults
Cryptococcal disease, including cryptococcal meningitis - 400 mg on the first day and then 200-400 mg daily; the usual duration of treatment is 6-8 weeks for meningitis; to prevent relapses in AIDS patients - 200 mg daily.

• Systemic candidiasis - 400 mg on the first day, followed by 200 mg once daily. Treatment lasts for at least 4 weeks and at least 2 weeks after the symptoms disappear.

• Mucosal candidiasis - a typical dose of 50-100 mg daily for 7-14 days; in ulcerative oral candidiasis 50 mg was administered for 14 days; in oropharyngeal and oesophageal candidiasis, the recommended dose of Fluconazole is 200 mg first day and 100 mg daily in the following days. Clinical healing is usually done for several days, but treatment should be continued for at least 2 weeks to prevent relapse. Doses up to 400 mg may be administered at the discretion of the physician. Treatment of oesophageal candidiasis should last at least 3 weeks and at least 2 weeks after the symptoms disappear; to prevent relapses in AIDS patients - 150 mg weekly;

• Genital candidiasis - single 150 mg; in order to avoid recurrence - 150 mg once a month, usually for 4-12 months; for candidiasis balanitis - single 150 mg;

• Prophylaxis of mycotic infections in some patient groups - 50-400 mg daily; treatment should begin several days before expected neutropenia and continue for 7 days after the neutrophil count reaches 1000 cells per mm3 or more;

• Dermatomycoses (Tinea pedis, tinea corporis, tinea cruris) and skin infections caused by C. albicans are administered 150 mg once a week or 50 mg once daily. For Tinea versicolor, the recommended dose is 50 mg once a day or 300 mg once a week. The duration of treatment is 2-4 weeks. In onychomycosis of the arms and legs - 150 mg once a week for 6-12 months.

• Endemic deep mycosis - 200-400 mg daily for 2 years; 11-24 months for coccidioidomycosis, 2-17 months for paracoccidioidomycosis, 1-16 months for sporocitracosis and 3-17 months for histoplasmosis.
Children

Doctor medication determines whether the dosage form is suitable for children and can it be administered according to the indicated doses.

Fluconazole is given once a day. The recommended dose for candidiasis of mucositis is 3 mg / kg / day. A dose of 6 mg / kg is administered on the first day.

For treatment of systemic candidiasis and infections caused by cryptococcus -6-12 mg / kg / day.

To prevent fungal infections in patients with impaired immune response - 3-12 mg / kg / day depending on the degree of neutropenia.

Children under 4 years of age

Excretion of the product in infants is slow. For the first 2 weeks after birth, the dose is as in older children, but at a 72-hour interval. During the third and fourth week after birth, the dose is administered at 48 hours. In children with chronic renal failure the dose should be based on creatinine clearance.

Elderly:

If there are no impairments in creatinine clearance, the usual doses described for adults are used.

Dosage in patients with impaired renal function

In patients with impaired renal function an initial dose of 50 mg to 400 mg of fluconazole is administered. After this loading dose, the daily dose is determined by the treating physician depending on the renal function.

BEHAVIOR BEHAVIOR

In case of overdose symptomatic treatment and gastric lavages are administered. Fluconazole is mainly secreted by urine; increased diuretic action increases the rate of elimination. Three-hour hemodialysis reduces plasma levels by approximately 50%.

UNDESIRABLE MEDICINAL REACTIONS

Applied at a dose of 150 mg Fluconazole is usually tolerated
You may experience side effects from:

Gastrointestinal tract - abdominal pain, diarrhea, nausea and vomiting. During treatment with Fluconazole, mild and transient increases in liver enzyme levels may occur. Very rarely, heavier liver function abnormalities are observed, especially in patients with impaired hepatic function requiring monitoring.

Elevated serum transaminases are most commonly seen with concomitant administration of fluconazole with liver-damaging products such as rifampicin, phenytoin, isoniazid, valproic acid or oral sulphonylurea antidiabetic agents.

• central nervous system - very rarely headaches and seizures may occur.

• bleeding system - leucopenia, thrombocytopenia.

STORAGE

At temperatures below 25 ° C.

Keep out of the reach and sight of children.

TIME LIMIT

3 (three) years

Do not use after the expiry date stated on the package!
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