Fluconazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Oropharyngeal candidiasis Treatment: Initially, 200-400 mg on Day 1, followed by 100-200 mg once daily for 7-21 days (until disease is in remission). Prevention of relapse in patients with HIV: 100-200 mg once daily, or 200 mg 3 times a week. Oesophageal candidiasis Treatment: Initially, 200-400 mg on Day 1, followed by 100-200 mg once daily for 14-30 days (until disease is in remission). Prevention of relapse in patients with HIV: 100-200 mg once daily, or 200 mg 3 times a week. Candiduria 200-400 mg once daily for 7-21 days. Chronic atrophic candidiasis 50 mg once daily for 14 days. Chronic mucocutaneous candidiasis 50-100 mg once daily for up to 28 days. Candidal balanitis; Vaginal candidiasis 150 mg given as a single dose. Treatment and prophylaxis of recurrent vaginal candidiasis (4 or more episodes a year): 150 mg every third day for a total of 3 doses (Day 1, 4, and 7), followed by a 150 mg once weekly maintenance dose (6 months). Dermatophytosis Tinea pedis, Tinea corporis, Tinea cruris, Candida infections: 150 mg once a week, or 50 mg once daily. Tinea versicolor: 300-400 mg once a week for 1-3 weeks, or 50 mg once daily for 2-4 weeks. Invasive candidiasis Initially, 800 mg on Day 1, followed by 400 mg once daily for 2 weeks. Cryptococcal meningitis Initially, 400 mg on Day 1, followed by 200-400 mg once daily, for at least 6-8 weeks. Prevention of relapse in patients with high risk of recurrence: 200 mg once daily. Coccidioidomycosis 200-400mg once daily for 11-24 months, or longer depending on severity of infection, clinical or mycologic response. Prophylaxis of fungal infections in immunocompromised patients In patients with prolonged neutropenia: 200-400 mg once daily. IV Oropharyngeal candidiasis Treatment: Initially, 200-400 mg on Day 1, followed by 100-200 mg once daily for 7-21 days (until disease is in remission). Prevention of relapse in patients with HIV: 100-200 mg once daily, or 200 mg 3 times a week. Oesophageal candidiasis Treatment: Initially, 200-400 mg on Day 1, followed by 100-200 mg once daily for 14-30 days (until disease is in remission). Prevention of relapse in patients with HIV: 100-200 mg once daily, or 200 mg 3 times a week. Candiduria 200-400 mg once daily for 7-21 days. Chronic atrophic candidiasis 50 mg once daily for 14 days. Chronic mucocutaneous candidiasis 50-100 mg once daily for up to 28 days. Invasive candidiasis Initially, 800 mg on Day 1, followed by 400 mg once daily for 2 weeks. Cryptococcal meningitis Initially, 400 mg on Day 1, followed by 200-400 mg once daily, for at least 6-8 weeks. Prevention of relapse in patients with high risk of recurrence: 200 mg once daily. Coccidioidomycosis 200-400mg once daily for 11-24 months, or longer depending on severity of infection, clinical or mycologic response. Prophylaxis of fungal infections in immunocompromised patients 200-400 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use with astemizole, cisapride, quinidine, terfenadine, pimozide, erythromycin.
Special Precautions
Patients with potentially proarrhythmic conditions (e.g. hypokalaemia, electrolyte abnormality, advanced cardiac failure), serious underlying disease (e.g. AIDS, malignancy). Renal and hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness or seizures, if affected, do not drive or operate machinery. Monitoring Parameters Monitor LFTs, renal function tests and serum K levels periodically.
Adverse Reactions
Significant: QT interval prolongation. Rarely, anaphylaxis. Blood and lymphatic system disorders: Agranulocytosis, anaemia, leucopenia, thrombocytopenia, neutropenia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, flatulence, dyspepsia, constipation, dry mouth. General disorders and administration site conditions: Fatigue, malaise, asthenia, fever. Immune system disorders: Angioedema, urticaria. Metabolism and nutrition disorders: Hypercholesteremia, hypertriglyceridaemia, hyperlipidaemia, hypokalaemia, anorexia. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Headache, dizziness, dysgeusia, paraesthesia, tremor, vertigo. Psychiatric disorders: Insomnia, somnolence. Skin and subcutaneous tissue disorders: Rash, pruritus, increased sweating, alopecia.
Potentially Fatal: Hepatic toxicity (e.g. cholestasis, hepatocellular damage, hepatitis, fulminant hepatic failure), ventricular arrhythmia, torsade de pointes. Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis.
C for a single dose of 150 mg for vaginal candidiasis
Drug Interactions
May increase prothrombin time with anticoagulants (e.g. warfarin). May increase serum concentrations of drugs metabolised by CYP3A4 and CYP2C9 isoenzymes (e.g. bosentan, ciclosporin, midazolam, nevirapine, amitriptyline, nortriptyline, phenytoin, rifabutin, sulfonylurea, nateglinide, celecoxib, parecoxib, tacrolimus, triazolam, zidovudine). May increase risk of myopathy and rhabdomyolysis with HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin). May decrease plasma clearance of theophylline. May reduce plasma concentration with rifampicin.
CIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
D01AC15 - fluconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Disclaimer: This information is independently developed by CIMS based on fluconazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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