Voriconazole Sandoz

Voriconazole

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.

Adult ≥15 yr Loading dose (1st 24 hr): ≥40 kg 400 mg every 12 hr, <40 kg 200 mg every 12 hr. Maintenance dose (after 1st 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.

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 LFTs become markedly elevated, if pre-malignant 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.

Visual disturbances, pyrexia, rash, vomiting, nausea, diarrhoea, headache, peripheral oedema, abnormal LFT, 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, flu-like illness, chills, increased blood creatinine.

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 C_max & AUC of efavirenz, sirolimus, tacrolimus, ciclosporin, oxycodone, methadone, ibuprofen, diclofenac, omeprazole, OCs (eg, norethisterone, ethinylestradiol). Decreased C_max & AUC w/ rifabutin, rifampicin, ritonavir, fluconazole, phenytoin. Decreased AUC_0-∞ 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 AUC_0-∞ of short-acting opiates (alfentanil & fentanyl). May inhibit metabolism of HIV PIs (eg, saquinavir, amprenavir & nelfinavir), NNRTIs (eg, delavirdine, nevirapine).

Antifungals

J02AC03 - voriconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

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