Apo-Fluconazole

Fluconazole

For oral treatment of vag candidiasis.

Recommended dose: 150 mg as single dose.

May be taken with or without food.

Hypersensitivity to fluconazole or related azole compd. Co-administration w/ terfenadine in patients receiving fluconazole at multiple doses of ≥400 mg; cisapride.

Occurrence of anaphylaxis in rare cases. Monitor for development of more severe hepatic injury in patients who develop abnormal LFTs during therapy. Discontinue use if clinical signs or symptoms consistent w/ liver disease develop; if rash develops in patient treated for superficial fungal infection. Closely monitor if rashes occur & discontinue use if bullous lesions or erythema multiforme develop in patients w/ invasive/systemic fungal infections. Patients have rarely developed exfoliative cutaneous reactions eg, SJS & TEN during treatment; AIDS patients are more prone to develop severe cutaneous reactions. Possible cardiac events including Torsades de pointes in patients receiving cisapride. Possible QT prolongation on ECG. Patients w/ potentially proarrhythmic conditions. In combination w/ ethinyl estradiol- & levonorgestrel-containing OCs. Consider using adequate contraception in women of childbearing potential. Pregnancy. Not recommended in nursing mothers. Childn <18 yr.

Headache; rash; abdominal pain, diarrhea, flatulence, nausea; hepatic toxicity including rare cases of fatalities, elevated alkaline phosphatase, bilirubin, SGOT & SGPT. QT prolongation, Torsade de pointes; dizziness, seizures; alopecia, exfoliative skin disorders including SJS & TEN; dyspepsia, vomiting; leukopenia including neutropenia, agranulocytosis, thrombocytopenia; anaphylaxis including angioedema, face edema, pruritus, urticaria; hepatic failure, hepatitis, hepatocellular necrosis, jaundice; hypercholesterolemia, hypertriglyceridemia, hypokalemia; taste perversion.

Increased AUC of ethinyl estradiol & levonorgestrel. May elevate serum levels of terfenadine & astemizole. Increased conc & psychomotor effects of midazolam. Increased AUC, C_max & t_1/2 of theophylline. Decreased AUC & C_max w/ cimetidine. Increased AUC, C_max, C_min & reduced oral clearance of cyclosporine. Increased serum levels of tacrolimus. Increased prothrombin time w/ coumarin-type anticoagulants (eg, warfarin). Increased AUC & C_max w/ hydrochlorothiazide. Increased plasma conc of oral hypoglycemics (eg, tolbutamide, glipizide & glyburide). Increased plasma conc of phenytoin. Enhanced metabolism w/ rifampin. Increased serum levels of rifabutin. Increased plasma conc of zidovudine.

Antifungals

J02AC01 - fluconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

POM

Exemptions granted for limited sale and supply without prescription (with effect from 1 Jan 2013) for 150 mg cap only:
As an oral preparation containing 150 mg
Indications: Vaginal Candidiasis
Maximum daily dose: 150 mg
Maximum supply: 1 tablet
Minimum age: 16 years. Not recommended in adults older than 60 years of age