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Diflucan

Diflucan

fluconazole

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
Cryptococcal meningitis & infections at other sites eg, pulmonary, cutaneous. Maintenance therapy to prevent cryptococcal disease relapse in AIDS patients. Candidemia, disseminated candidiasis & other invasive candidal infections. Mucosal candidiasis eg, oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis. Prevention of oropharyngeal candidiasis relapse in AIDS patients. Acute or recurrent vag candidiasis; prophylaxis to reduce vag candidiasis recurrence. Candidal balanitis. Prevention of fungal infections in malignant patients. Dermatomycosis eg, 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. Cryptococcal meningitis At least 6-8 wk. Prevention of cryptococcal meningitis relapse in AIDS patient 200 mg once daily after full course of primary therapy. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on 1st day followed by 200 mg once daily, may be increased to 400 mg once 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 measures to dentures. Other mucosal candida infections except genital candidiasis 50-100 mg once daily for 14-30 days. Prevention of oropharyngeal candidiasis relapse in AIDS patient 150 mg once wkly after full course of primary therapy. Vag candidiasis & candida balanitis 150 mg single oral dose. Reduce recurrence of vag candidiasis 150 mg once mthly for 4-12 mth. Prevention of candidiasis 50-400 mg once daily. Patient at high risk of systemic infection 400 mg once daily. Dermal infections eg, tinea pedis, corporis, cruris & Candida infections 150 mg once wkly or 50 mg once daily for 2-4 wk; tinea pedis for up to 6 wk. Tinea versicolor 300 mg once wkly for 2 wk or 50 mg once daily for 2-4 wk. Childn Mucosal candidiasis Loading dose: 6 mg/kg on 1st day followed by 3 mg/kg once daily. Systemic candidiasis & cryptococcal infections 6-12 mg/kg once daily. Suppression of cryptococcal meningitis relapse in childn w/ AIDS 6 mg/kg once daily. Prevention of fungal infections in immunocompromised patient considered at risk as consequence of neutropenia following cytotoxic chemo- or RT 3-12 mg/kg once daily. Neonate Dose of older childn administered every 72 hr for neonate up to 2 wk & every 48 hr for neonate 3-4 wk. Renal impairment Loading dose: Initially 50-400 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to fluconazole or related azole compd. Co-administration of terfenadine in patients receiving multiple doses of fluconazole ≥400 mg daily; CYP3A4-metabolized drugs prolonging QT interval.
Special Precautions
Anaphylaxis. Discontinue use if rash develops in patients treated for superficial fungal infection or w/ invasive/systemic fungal infection. Exfoliative cutaneous reactions eg, SJS, TEN, DRESS; QT interval prolongation, Torsade de pointes; structural heart disease, electrolyte abnormalities, hypokalemia, advance cardiac failure; potentially proarrhythmic conditions; adrenal insufficiency. Monitor closely & discontinue use if bullous lesions or erythema multiforme develops. Concomitant use w/ terfenadine; narrow therapeutic window drugs metabolized by CYP2C9, CYP2C19 & CYP3A4. Increasing prevalence of resistance in various Candida sp. AIDS patients. Not to be given in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Monitor for development of more serious hepatic injury. Hepatic & renal dysfunction. Women of childbearing potential should use effective contraception during & approx 1 wk after last dose. Avoid use during pregnancy. Not recommended during lactation.
Adverse Reactions
Headache; abdominal pain, diarrhoea, nausea, vomiting; increased ALT, AST & blood alkaline phosphatase; rash.
Drug Interactions
Increased plasma levels of cisapride, terfenadine, rifabutin, tacrolimus, vinca alkaloids. Decreased astemizole clearance. Inhibition of pimozide, quinidine, carbamazepine, losartan metabolism. Increased risk of cardiotoxicity w/ erythromycin. Increased QT prolongation w/ amiodarone. Increased Cmax & AUC of lemborexant, saquinavir, celecoxib, tolvaptan, voriconazole, zidovudine. Increased plasma conc by hydrochlorothiazide. Decreased AUC & shorter t½ w/ rifampicin. Increased plasma conc of other CYP2C9-, CYP2C19- & CYP3A4-metabolized compd; halofantrine, ibrutinib, lurasidone, olaparib, sirolimus. Higher exposure of abrocitinib. Reduced clearance, distribution vol & prolonged t½ of alfentanil. Increased amitriptyline & nortriptyline effects. Increased prothrombin time w/ warfarin. Increased conc & psychomotor effects w/ midazolam. Increased AUC, Cmax & t½ of triazolam. Increased systemic exposure of Ca-channel blockers, tofacitinib. Increased AUC of cyclosporine, ethinyl estradiol & levonorgestrel. Increased serum bilirubin & creatinine w/ cyclophosphamide. Delayed fentanyl elimination. Increased risk of myopathy & rhabdomyolysis w/ HMG-CoA reductase inhibitors. Increased ivacaftor exposure. Enhanced serum conc of methadone. Potentially increased systemic exposure of NSAIDs metabolized by CYP2C9. Inhibits hepatic metabolism of phenytoin. Increased metabolism of prednisone. Prolonged serum t½ of oral sulfonylureas. Decreased mean plasma clearance rate of theophylline. Developed CNS undesirable effects w/ vit A.
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
Diflucan cap 100 mg
Packing/Price
28's
Form
Diflucan cap 150 mg
Packing/Price
1's
Form
Diflucan cap 50 mg
Packing/Price
7's
Form
Diflucan soln for infusion (vial) 2 mg/mL
Packing/Price
100 mL x 1's;50 mL x 1's
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