Biozole

Biozole

fluconazole

Manufacturer:

Biolab

Distributor:

Biopharm
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
Cryptococcosis including cryptococcal meningitis & infections of other sites eg, pulmonary, cutaneous in normal hosts & organ transplant, AIDS & immunocompromised patients. Maintenance therapy to prevent relapse of cryptococcal disease in AIDS patients. Systemic candidiasis including candidemia, disseminated candidiasis & other forms of invasive candida infection including peritoneum, endocardium & pulmonary infections & UTI in patients w/ malignancy, in ICU, receiving cytotoxic or immunosuppressive therapy, or w/ other factors predisposing to candida infection. Mucosal candidiasis including oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis (denture sore mouth) in normal hosts & patients w/ compromised immune function. Acute or recurrent vag candidiasis. Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor & candida infections. Prevention of fungal infection in patients w/ malignancy who are predisposed to such infections as result of cytotoxic chemotherapy or RT.
Dosage/Direction for Use
Adult Cryptococcal meningitis & infections at other sites, candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on 1st day followed by 200 mg once daily. May be increased to 400 mg daily. Treatment duration: 6-8 wk for cryptococcal meningitis. Prevention of relapse of cryptococcal meningitis in patients w/ AIDS 200 mg daily following full course of primary therapy. Oropharyngeal candidiasis 50 mg once daily for 7-14 days. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days. Other mucosal candida infections (except vag candidiasis) 50 mg daily for 14-30 days. May be increased to 100 mg daily in unusually difficult cases. Vag candidiasis 150 mg as single dose. Tinea pedis, tinea corporis, tinea cruris & candida infections 150 mg once wkly or 50 mg once daily for 2-4 wk (up to 6 wk for Tinea pedis). Tinea versicolor 50 mg once daily for 2-4 wk. Tinea unguium 150-450 mg once wkly for 3-12 mth. Prevention of fungal infection in patients w/ malignancy 50 mg once daily. Prevention of candidiasis 50-400 mg once daily. Patient at high risk of systemic infection 400 mg once daily. Start treatment several days before anticipated onset of neutropenia & continue for 7 days after neutrophil count rise >1,000 cells/mm3. Childn >1 yr w/ normal renal function Superficial candidal infections 1-2 mg/kg daily. Systemic candidal/cryptococcal infections 3-6 mg/kg daily. Childn ≤4 wk 1-2 mg/kg administered every 72 hr then decrease to once daily after 2 wk. Renal impairment CrCl >40 mL/min Normal daily dose every 24 hr, 21-40 mL/min ½ of normal daily dose or normal dose every 48 hr, 10-20 mL/min 1/3 of normal daily dose or normal dose every 72 hr. Patient on regular dialysis 1 dose after every dialysis session.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to fluconazole or related azole compounds. Coadministration w/ terfenadine & cisapride.
Special Precautions
Anaphylaxis. Discontinue if rash, bullous lesions or erythema multiforme develop. Patients w/ severe underlying disease; AIDS patients; w/ potentially proarryhthmic conditions. Prolongation of QT interval. Assess patients in whom significant rise of liver enzymes occurs. Closely monitor patients w/ invasive/systemic fungal infections. Coadministration w/ terfenadine. Avoid use during pregnancy. Not recommended in lactation. Not recommended in childn <16 yr.
Adverse Reactions
Headache, dizziness, somnolence, seizures; hepatotoxicity, elevated alkaline phosphatase, bilirubin, SGOT & SGPT, transient hepatic reactions including hepatitis & jaundice; leukopenia including neutropenia & agranulocytosis, thrombocytopenia; hypercholesterolemia, hypertriglyceridemia, hypokalemia; nausea, abdominal pain, diarrhea, flatulence; rash, exfoliative skin disorders including SJS & TEN, anaphylaxis, angioedema, pruritus, alopecia.
Drug Interactions
Increased prothrombin time w/ warfarin. Prolonged serum t½ of oral sulfonylureas eg, chlorpropamide, glibenclamide, glipizide, tolbutamide. Increased levels of phenytoin. Decreased AUC & shorter t½ w/ rifampicin. Concomitant use w/ cyclosporine & benzodiazepine. Decreased mean plasma clearance rate of theophylline. Increased conc of midazolam. Increased plasma levels/conc of cisapride; hydrochlorothiazide; terfenadine. Increased AUC of ethinyl estradiol, levonorgestrel & norethindrone. Increased serum levels of rifabutin; tacrolimus; astemizole. Increased AUC, peak serum conc & terminal elimination t½ of zidovudine.
MIMS Class
Antifungals
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Biozole cap 150 mg
Packing/Price
50 × 1's
Form
Biozole cap 200 mg
Packing/Price
5 × 10's
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