Mega Lifesciences
Concise Prescribing Info
Invasive aspergillosis, candidaemia (non-neutropenic patients), fluconazole-resistant serious invasive Candida infections (including C. krusei), serious fungal infections caused by Scedosporium spp & Fusarium spp in adults & childn ≥2 yr.
Dosage/Direction for Use
Adult >18 yr weighing ≥40 kg Loading dose (1st 24 hr): 400 mg 12 hrly. Maintenance dose (after 1st 24 hr): 200 mg bd. Dose may be increased to 300 mg bd if response is inadequate or may be reduced by 50 mg steps to 200 mg bd if unable to tolerate treatment. Patient ≥15 yr weighing <40 kg Loading dose (1st 24 hr): 200 mg 12 hrly. Maintenance dose (after 1st 24 hr): 100 mg bd. Dose may be increased to 150 mg bd if response is inadequate or may be reduced by 50 mg steps to 100 mg bd if unable to tolerate treatment. Childn (2 to <12 yr) & young adolescent w/ low body wt (12-14 yr & <50 kg) Maintenance dose (after 1st 24 hr): 9 mg/kg bd. Max: 350 mg bd. Dose may be increased if response is inadequate or reduced if unable to tolerate treatment by 1 mg/kg steps (or 50 mg steps if max dose was initially used). It is recommended to initiate therapy w/ IV regimen.
Should be taken on an empty stomach: Take at least 1 hr before or after a meal.
Hypersensitivity. Acute porphyria. Co-administration w/ CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine; rifampicin, carbamazepine & phenobarb; high dose efavirenz (≥400 mg once daily); high dose ritonavir (≥400 mg bd); ergot alkaloids (eg, ergotamine, dihydroergotamine); sirolimus; St. John's wort.
Special Precautions
Monitor & correct electrolyte disturbances (eg, hypokalaemia, hypomagnesaemia & hypocalcaemia) prior to & during therapy. Cardiomyopathy, bradycardia, symptomatic arrhythmias, history of QT interval prolongation. Patients at risk of pancreatitis. Avoid sunlight exposure. Monitor renal function. Concomitant use w/ other drugs that prolong QT interval. Monitor for liver function tests elevations, clinical signs of liver damage & drug toxicity in patients w/ hepatic impairment. Childn <2 yr.
Adverse Reactions
Nausea, vomiting, abdominal & chest pain, diarrhoea, jaundice, oedema, hypotension, resp distress syndrome, sinusitis headache, dizziness, asthenia, anxiety, depression, confusion, agitation, hallucinations, paraesthesia, tremor, flu-like symptoms, hypoglycaemia, haematuria, blood disorders (including anaemia, thrombocytopenia, leucopenia, pancytopenia), acute renal failure, hypokalaemia, visual disturbances (including altered perception, blurred vision, & photophobia), rash, pruritus, photosensitivity, alopecia, cheilitis, inj site reactions.
Drug Interactions
Contraindicated: efavirenz, rifampicin, high-dose ritonavir, St. John's wort, sirolimus; astemizole, cisapride, pimozide, quinidine & terfenadine due to increased plasma conc of these products & QTc prolongation; carbamazepine & long-acting barbiturates (eg, phenobarb, mephobarbital) due to decreased voriconazole plasma conc. Avoid: rifabutin, low-dose ritonavir, phenytoin. Not recommended: everolimus (increased plasma conc). May increase plasma conc of: benzodiazepines (eg, midazolam, triazolam, alprazolam); proton-pump inhibitors (eg, omeprazole); statins (eg, lovastatin); sulphonylureas (eg, tolbutamide, glipizide, glyburide); vinca alkaloids (eg, vincristine & vinblastine). Max increase in prothrombin time w/ anticoagulants eg, warfarin, coumarins (eg, phenprocoumon, acenocoumarol). May increase levels of ciclosporin, tacrolimus. Monitor for voriconazole-associated adverse reactions when used sequentially after fluconazole. Frequent monitoring for adverse reactions &/or toxicity which may necessitate dose reduction for the following: short- (eg, alfentanil, fentanyl) & long-acting opiates (eg, oxycodone), methadone, NSAIDs, OCs (eg, norethisterone/ethinylestradiol).
MIMS Class
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Voriole FC tab 200 mg
Voriole FC tab 50 mg
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