Voriconazole Sandoz

Voriconazole Sandoz





Zuellig Pharma
Concise Prescribing Info
Invasive aspergillosis; candidemia in non-neutropenic patients; fluconazole-resistant serious invasive Candida infections (including C. krusei); esophageal candidiasis; serious fungal infections caused by Scedosporium spp. & Fusarium spp.; other serious fungal infections in patients intolerant of, or refractory to, other therapy. Prevention of breakthrough of fungal infections in febrile high-risk patients (allogenic bone marrow transplants, relapsed leukemia patients). Prophylaxis in patients who are at high risk of developing invasive fungal infections eg, haematopoietic stem cell transplant (HSCT) recipients.
Dosage/Direction for Use
Adult ≥15 yr Loading dose (first 24 hr): ≥40 kg 400 mg every 12 hr, <40 kg 200 mg every 12 hr. Maintenance dose (after first 24 hr): ≥40 kg 200 mg bid. Dose may be increased to 300 mg bid, <40 kg 100 mg bid. May be increased to 150 mg bid. If patient is unable to tolerate treatment at higher dose: Reduce 50 mg steps to the 200 mg or 100 mg (for patients <40 kg) bid. Prophylaxis Childn 2-12 yr & adolescents 12-14 yr w/ low body wt (<50 kg) Maintenance dose: 9 mg/kg bid. Max: 350 mg bid.
Should be taken on an empty stomach: Take at least 1 hr before or after meal.
Hypersensitivity. Coadministration w/ CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine, ergot alkaloids; rifampicin, carbamazepine, phenobarb, efavirenz ≥400 mg once daily, high-dose ritonavir (≥400 mg & bid); sirolimus; St. John's wort.
Special Precautions
Hypersensitivity to other azoles. Patients w/ potentially proarrythmic conditions (eg, congenital or acquired QTc-prolongation, cardiomyopathy, sinus bradycardia, existing symptomatic arrhythmias, concomitant medicinal products that are known to prolong QTc interval). Monitor for electrolyte disturbances eg, hypokalaemia, hypomagnesemia & hypocalcaemia & correct prior to initiation during therapy; hepatic (prior to treatment & at least wkly for the 1st mth of treatment), renal, pancreatic (especially childn) function. Discontinue treatment if liver function tests become markedly elevated, if premalignant skin lesions or squamous cell carcinoma is identified & skeletal pain & radiologic findings compatible w/ periostitis develops. Prolonged visual & dermatological adverse reactions. Avoid exposure to direct sunlight. Long-term treatment >6 mth. Concomitant use w/ phenytoin, efavirenz, rifabutin, ritonavir, everolimus, methadone, alfentanil, fentanyl & other short-acting opiates, oxycodone & other long-acting opiates & fluconazole. Women of childbearing potential. May affect ability to drive or operate machinery. Pregnancy & lactation. Ped patients.
Adverse Reactions
Visual disturbances, pyrexia, rash, vomiting, nausea, diarrhoea, headache, peripheral oedema, abnormal liver function test, resp distress & abdominal pain. Gastroenteritis, sinusitis, gingivitis; agranulocytosis, pancytopenia, thrombocytopenia, anemia; hypersensitivity; hypoglycaemia, hypokalaemia, hyponatraemia; depression, hallucination, anxiety, insomnia, agitation, confusional state; convulsion, tremor, paraesthesia, hypertonia, somnolence, syncope, dizziness; retinal haemorrhage; arrhythmia supraventricular, tachycardia, bradycardia; hypotension, phlebitis; acute resp distress syndrome, pulmonary oedema; dyspepsia, constipation, cheilitis; jaundice, cholestatic jaundice, hepatitis; exfoliative dermatitis, maculo-papular rash, pruritus, alopecia, erythema; back pain; acute renal failure, haematuria; chest pain, face oedema, asthenia, influenza-like illness, chills, increased blood creatinine.
Drug Interactions
Astemizole, cisapride, pimozide, quinidine, terfenadine; carbamazepine & long-acting barbiturates (eg, phenobarb, mephobarbital); ergot alkaloids (eg, ergotamine & dihydroergotamine); warfarin & other oral coumarins (eg, phenprocoumon, acenocoumarol); long-acting opiates. May increase Cmax & AUC of efavirenz, sirolimus, tacrolimus, ciclosporin, oxycodone, methadone, ibuprofen, diclofenac, omeprazole, OCs (eg, norethisterone, ethinylestradiol). Decreased Cmax & AUC w/ rifabutin, rifampicin, ritonavir, fluconazole, phenytoin. Decreased AUC0-∞ w/ St. John's wort. Increase conc of everolimus. May increase plasma conc of benzodiazepines (eg, midazolam, triazolam, alprazolam), statins (eg, lovastatin), sulfonylureas (eg, tolbutamide, glipizide, glyburide), vinca alkaloids (eg, vincristine & vinblastine). Increase AUC0-∞ of short-acting opiates (alfentanil & fentanyl). May inhibit metabolism of HIV PIs (eg, saquinavir, amprenavir & nelfinavir), NNRTIs (eg, delavirdine, nevirapine).
MIMS Class
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Voriconazole Sandoz FC tab 200 mg
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