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Administration
May be taken with or without food.
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Contraindications
Hypersensitivity. Concomitant use with astemizole, cisapride, quinidine, terfenadine, pimozide, erythromycin.
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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.
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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. |
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ROUTE(S) : PO: C
For a single dose of 150 mg for vaginal candidiasis.
ROUTE(S) : PO: D
For use in indications other than vaginal candidiasis.
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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.
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CIMS Class
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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. |
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