Diflucan

Diflucan

fluconazole

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
Cryptococcosis, including cryptococcal meningitis & infections of other sites (eg, pulmonary, cutaneous). Normal hosts & patients w/ AIDS, organ transplants or other causes of immunosuppression. Maintenance therapy to prevent relapse of cryptococcal disease in patients w/ AIDS. Systemic candidiasis, including candidemia, disseminated candidiasis & other forms of invasive candidal infections including infections of the peritoneum, endocardium, eye, & pulmonary & urinary tracts. Patients w/ malignancy, in ICU, receiving cytotoxic or immunosuppressive therapy, or w/ other factors predisposing to candidal infection. Mucosal candidiasis including oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis (denture sore mouth). Normal hosts & patients w/ compromised immune function. Prevention of relapse of oropharyngeal candidiasis in patients w/ AIDS. Genital candidiasis; vag candidiasis (acute or recurrent), & prophylaxis to reduce the incidence of recurrent vag candidiasis (≥3 episodes a yr); candidal balanitis. Prevention of fungal infections in patients w/ malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or RT. Dermatomycosis, including tinea pedis, tinea corporis, tinea cruris, tinea versicolor, tinea unguium (onychomycosis), & dermal Candida infections. Deep endemic mycoses in immunocompetent patients, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis & histoplasmosis.
Dosage/Direction for Use
Adult Cryptococcal meningitis & cryptococcal infections at other sites 400 mg on the 1st day followed by 200-400 mg once daily. Administer at least 6-8 wk for cryptococcal meningitis. Prevention of relapse of cryptococcal meningitis in patient w/ AIDS after a full course of primary therapy Administer indefinitely at 200 mg once daily. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on the 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. Can be continued for longer periods in patient w/ severely compromised immune function. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days concurrently w/ local antiseptic measures to the denture. Other candidal infections of mucosa except genital candidiasis (eg, esophagitis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis) 50-100 mg once daily for 14-30 days. Prevention of relapse of oropharyngeal candidiasis in patient w/ AIDS after a full course of primary therapy 150 mg once wkly. Vag candidiasis & candida balanitis 150 mg as single oral dose. Recurrent vag candidiasis incidence reduction 150 mg once mthly for 4-12 mth. Prevention of candidiasis 50-400 mg once daily. Patient at high risk of systemic infection eg, patient w/ anticipated profound or prolonged neutropenia 400 mg once daily, starting several days before the anticipated onset of neutropenia & continue for 7 days after the neutrophil count rise >1,000 cell/mm3. Dermal infections including tinea pedis, tinea corporis, tinea cruris & candida infections 150 mg once wkly or 50 mg once daily. Duration of treatment: 2-4 wk, but tinea pedis may require for up to 6 wk. Tinea versicolor 300 mg once wkly for 2 wk. 3rd wkly dose of 300 mg may be needed in some patient, whereas, a single dose of 300-400 mg may be sufficient. Alternate dosing regimen: 50 mg once daily for 2-4 wk. Tinea unguium 150 mg once wkly, continued until infected nail is replaced (uninfected nail grows in). Deep endemic mycoses 200-400 mg once daily for up to 2 yr. Duration of therapy: Coccidioidomycosis 11-24 mth; paracoccidioidomycosis 2-17 mth; sporotrichosis 1-16 mth; histoplasmosis 3-17 mth. Childn Mucosal candidiasis 3 mg/kg once daily. Loading dose: 6 mg/kg on the 1st day. Systemic candidiasis & cryptococcal infections 6-12 mg/kg once daily. Suppression of relapse of cryptococcal meningitis in childn w/ AIDS 6 mg/kg once daily. Prevention of fungal infections in immunocompromised patient considered at risk as a consequence of neutropenia following cytotoxic chemotherapy or RT 3-12 mg/kg once daily. Neonate ≤4 wk 1st 2 wk of life: Same dose w/ older childn administered every 72 hr. Wk 3 & 4 of life: Same dose should be given every 48 hr. Renal impairment in adult & childn Initial loading dose: 50-400 mg. CrCl >50 mL/min 100% recommended dose; ≤50 mL/min (no dialysis) 50% recommended dose. Hemodialysis 100% recommended dose after each hemodialysis. Reduce dose according to the patient's CrCl on non-dialysis days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to fluconazole or related azole compd. Co-administration w/ terfenadine & other drugs known to prolong the QT interval & those metabolized via CYP3A4 enzyme eg, cisapride, astemizole, erythromycin, pimozide & quinidine.
Special Precautions
Monitor for the development of more serious hepatic injury in patients who develop abnormal LFTs during therapy. AIDS patients. Discontinue further therapy if a rash, which is considered attributable to therapy, develops in patient treated for superficial fungal infection. Closely monitor if patients w/ invasive/systemic fungal infections develop rashes & discontinue use if bullous lesions or erythema multiforme develop. QT interval prolongation on the ECG. Increased risk for the occurrence of life-threatening ventricular arrhythmias & torsade de pointes in patients w/ hypokalemia & advanced cardiac failure. Patients w/ potentially proarrhythmic conditions. Adrenal insufficiency. Prevalence of resistance in various Candida sp. Concomitant use w/ amiodarone & other azoles (eg, ketoconazole). Concomitant treatment w/ drugs w/ a narrow therapeutic window. Galactose intolerance, Lapp-lactase deficiency or glucose- galactose malabsorption. Liver & renal dysfunction. May affect ability to drive or operate machinery. Women of child-bearing potential should use effective contraceptive measures & continue throughout the treatment period & for approx 1 wk after the final dose. Pregnancy & lactation.
Adverse Reactions
Headache; abdominal pain, diarrhea, nausea, vomiting; increased ALT, AST & blood alkaline phosphatase; rash.
Drug Interactions
Increased plasma levels of cisapride, terfenadine, vinca alkaloids (eg, vincristine & vinblastine). Decreased clearance of astemizole. Inhibited metabolism of pimozide, quinidine, carbamazepine, & losartan. Increased risk of cardiotoxicity w/ erythromycin. Increased QT prolongation w/ amiodarone. Increased Cmax & AUC of lemborexant, celecoxib, voriconazole, zidovudine. Increased plasma conc w/ hydrochlorothiazide. Decreased AUC & shorter t½ w/ rifampicin. Reduced clearance, distribution vol & prolonged t½ of alfentanil. Increased effect of amitriptyline & nortriptyline. Increased prothrombin time w/ warfarin. Increased conc & psychomotor effects of midazolam. Increased AUC, Cmax & t½ of triazolam. Increased systemic exposure of Ca-channel blockers & tofacitinib. Increased conc & AUC of cyclosporin. Increased serum bilirubin & creatinine w/ cyclophosphamide. Delayed elimination of fentanyl. Increased plasma conc of halofantrine, lurasidone, olaparib, & sirolimus. Increased risk of myopathy & rhabdomyolysis w/ HMG-CoA reductase inhibitors eg, atorvastatin, simvastatin, or fluvastatin. Increased ibrutinib plasma conc & risk of toxicity. Increased ivacaftor exposure. May enhance serum conc of methadone. Increased systemic exposure of NSAIDs (eg, naproxen, lornoxicam, meloxicam, diclofenac). Increased AUC of ethinyl estradiol & levonorgesrel. Inhibited hepatic metabolism of phenytoin. Increased metabolism of prednisone. Increased serum levels of rifabutin. Increased AUC & Cmax, & decreased clearance of saquinavir. Prolonged serum t½ of oral sulfonylureas (eg, chlorpropamide, glibenclamide, glipizide, tolbutamide). May increase serum conc of oral tacrolimus. Decreased mean plasma clearance rate of theophylline. Increased exposure to tolvaptan. 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 150 mg
Packing/Price
10's
Form
Diflucan cap 200 mg
Packing/Price
28's
Form
Diflucan cap 50 mg
Packing/Price
28's
Form
Diflucan inj 2 mg/mL
Packing/Price
100 mL x 1's
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