Axcel Fluconazole

Axcel Fluconazole



Kotra Pharma


Kotra Pharma
Concise Prescribing Info
Cryptococcosis ie, cryptococcal meningitis & infections of other sites (eg, pulmonary, cutaneous). Maintenance therapy to prevent relapse of cryptococcal disease in patients w/ AIDS. Systemic candidiasis ie, candidemia, disseminated candidiasis & other forms of invasive candidal infection. Mucosal candidiasis. Prevention of oropharyngeal candidiasis relapse in patients w/ AIDS. Acute or recurrent genital & vag candidiasis; prophylaxis to reduce incidence of recurrent vag candidiasis. Candidal balanitis. Prevention of fungal infections in patients w/ malignancy who are predisposed to such infections as a result of cytotoxic chemo- or radiotherapy. Dermatomycosis ie, tinea pedis, corporis, cruris & versicolor; dermal candida infections.
Dosage/Direction for Use
Adult Cryptococcal meningitis & cryptococcal infections at other sites 400 mg on 1st day followed by 200-400 mg once daily. Duration of treatment for cryptococcal meningitis: 6-8 wk. Prevention of cryptococcal meningitis relapse in patient w/ AIDS 200 mg daily after receiving full course of primary therapy. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on 1st day followed by 200 mg daily, may be increased to 400 mg daily. Oropharyngeal candidiasis 50-100 mg once daily for 7-14 days. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days, concurrently w/ local antiseptic. Other candidal mucosa infections (except genital candidiasis) 50-100 mg daily for 14-30 days. Prevention of oropharyngeal candidiasis relapse in patient w/ AIDS 150 mg once wkly after receiving full course of primary therapy. Vag candidiasis, candida balanitis 150 mg as single oral dose. Reduce incidence of recurrent vag candidiasis 150 mg once mthly for 4-12 mth. Prevention of candidiasis 50-400 mg once daily. Prevention of fungal infections in patient at risk of systemic infection (eg, w/ profound or prolonged neutropenia) 400 mg once daily for 7 days. Dermal infections eg, tinea pedis, corporis & cruris & candida infections 150 mg once wkly or 50 mg once daily for 2-4 wk. Tinea pedis: Up to 6 wk. Tinea versicolor 300 mg once wkly for 2-3 wk or 300-400 mg single dose or 50 mg once daily for 2-4 wk. Childn Mucosal candidiasis Loading dose: 6 mg/kg on the 1st day followed by 3 mg/kg daily. Systemic candidiasis & cryptococcal infections 6-12 mg/kg daily. Prevention of fungal infections in immunocompromised patient 3-12 mg/kg daily. Renal impairment Initial loading dose: 50-400 mg.
May be taken with or without food.
Hypersensitivity to azole compd. Co-administration w/ terfenadine, cisapride, pimozide & halofantrine. Pregnancy & lactation.
Special Precautions
Monitor for development of more serious hepatic injury. Discontinue use if rash or if signs & symptoms of liver disease occur. Potentially proarrhythmic conditions. Avoid use during pregnancy. Not recommended during lactation.
Adverse Reactions
Headache; abdominal pain, diarrhoea, flatulence, nausea, dyspepsia, vomiting; hepatic toxicity, elevated liver enzymes, hepatic failure, hepatitis, hepatocellular necrosis, jaundice; rash, alopecia, Stevens-Johnson syndrome, toxic epidermal necrolysis; leukopenia, neutropenia, agranulocytosis, thrombocytopenia; anaphylaxis, angioedema, face edema, pruritus, urticaria; hypercholesterolemia, hypertriglyceridemia, hypokalemia; dizziness, seizures, taste perversion; QT prolongation, Torsade de pointes.
Drug Interactions
Increased prothrombin time w/ warfarin. Increased conc & psychomotor effects of midazolam. Increased risk of ventricular arrythmia w/ cisapride, pimozide. Increased conc of cyclosporin. Increased plasma conc by hydrochlorothiazide. Increased levels of phenytoin, zidovudine. Increased serum levels of rifabutin, tacrolimus, astemizole & other CYP450-metabolised drugs. Decreased AUC & shorter t½ w/ rifampicin. Prolonged serum t½ of sulfonylureas eg, chlorpropamide, glibenclamide, glipizide & tolbutamide. Prolonged QTc interval w/ terfenadine. Decreased mean plasma clearance rate of theophylline.
MIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Axcel Fluconazole cap 150 mg
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