Composition
Inf 200 mg: Voriconazole 200 mg. Tab 50 mg/200 mg: Voriconazole 50 mg/200 mg.
Indications & Dosage
Invasive aspergillosis, Serious infections caused by Scedosporium spp., Fusarium spp., or invasive fluconazole-resistant Candida spp. (including C. krusei): ORAL: Adult (body-weight up to 40 kg): Initially 200 mg every 12 hours for 2 doses, then 100 mg every 12 hours, increased if necessary to 150 mg every 12 hours; Adult (body-weight 40 kg and above): Initially 400 mg every 12 hours for 2 doses, then 200 mg every 12 hours, increased if necessary to 300 mg every 12 hours. Tab should be taken 1 hr before or 1 hr after food; susp should be taken 1 hr before or 2 hr after food. Children 2-12 yrs: 9 mg/kg twice daily (preferred as susp<12 yr), increase if necessary in 1 mg/kg increments (50 mg increments if initial dose was 350 mg); max 350 mg twice daily; 12-14 yr and body wt< 50 kg, same as adults. Tab should be taken 1 hr before or 1 hr after food; susp should be taken 1 hr before or 2 hr after food. BY IV INF: Adult: Initially 6 mg/kg every 12 hours for 2 doses, then4 mg/kg every 12 hours; reduced if not tolerated to 3 mg/kg every 12 hours; for max 6 months Children 2-14 yrs: and less than 50 kg, Loading dose: For first hrs, 9 mg/kg by IV inf every 12 hrs. Maintenance; 8 mg/kg by IV inf twice daily; above 14 yrs: same as adults. If response inadequate, maintenance dose may be increased in 1 mg/kg steps. If not tolerated, it may be reduced in 1 mg/kg steps. Max inf. Rate 3 mg/kg/hr over 1-3 hr.
Administration
Administer by IV infusion in a compatible infusion solution at a concentration between 0.5 and 5 mg/ml over 1 to 2 hours at a max rate of 3 mg/kg/hour. Reconstitute with 19 ml of SWFI and shake well to yield 20 ml of voriconazole 10 mg/ml solution.
Compatibility
Dextrose 5%, NaCI 0.9%.
Stability
Reconstituted stable for 24 hours under refrigera-tion, use immediately after reconstitution because no antimicrobial preservative is present. Single use only and any remaining drug should be discarded.
Contraindications
Acute porphyrias
Precautions
Avoid exposure to sunlight, bradycardia, Cardiomyopathy, history of QT interval prolongation, patients at risk of pancreatitis, symptomatic arrhythmias, hepatic impairment or cirrhosis; monitor LFTs, bilirubin, discontinue if liver disease develops. Monitor renal function. Acute pancreatitis; monitor serum Amylase or lipase, electrolyte imbalance; monitor and correct prior to and during therapy, pregnancy, use effective contraception. Inf: moderate to severe renal impairment (CrCI< 50 ml/min).
Interactions
Rifabutin, rifampicin, phenytoin, carbamazepine, Phenobarbital, cimetidine, cisapride, pimozide, ergot alkaloids, fluconazole coumarins, statins, benzodiazepines, vinca alkaloids, sirolimus, everolimus, other immu-nosuppressants, NSAIDs, opiates other substrates, indicators or inducers of CYP3A4, CYP2C19 and CYP2C9 drugs that prolong QT interval, St. Johns Wort.
Pregnancy
Caution advised, avoid
Lactation
Contraindicated
Side Effects
Abdominal pain, acute renal failure, agitation, alopecia, altered perception, anaemia, anxiety, asthenia, blood disorders, blurred vision, cheilitis, chest pain, confusion, depression, diarrhoea, dizziness, haematuria, hallucinations, headache, hypoglycaemia, hypokalaemia, hypotension, influenza-like symptoms, jaundice, leucopenia, nausea, oedema, pancytopenia, paraesthesia, photophobia, photo sensitivity, pruritus, rash, respiratory distress syndrome, sinusitis, thrombocytopenia, tremor, visual disturbances, vomiting