VFEND I.V. for INJECTION Rx
Generic Name and Formulations:
Voriconazole 200mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Indications for VFEND I.V. for INJECTION:
Invasive aspergillosis. Nonneutropenic candidemia. Candida infections in abdomen, kidney, bladder wall, wounds, or skin (disseminated). Esophageal candidiasis. Serious infections caused by Scedosporium apiospermum and Fusarium species in patients refractory to, or intolerant of, other agents.
See full labeling. Infuse IV over 1–2hrs; max rate 3mg/kg per hour. Aspergillosis, other serious infections: initially 6mg/kg IV every 12hrs for 2 doses, then 4mg/kg every 12hrs. Candidemia, other deep tissue candida infections: initially 6mg/kg IV every 12hrs for 2 doses, then 3–4mg/kg every 12hrs; treat for at least 14 days after symptoms resolve or following last positive culture, whichever is longer. Both: switch to oral form when tolerated; give 1hr before or after meals. Oral forms: <40kg: 100mg every 12hrs; may increase to 150mg every 12hrs if inadequate response; ≥40kg: 200mg every 12hrs; may increase to 300mg every 12hrs if inadequate response. Esophageal candidiasis: oral forms: <40kg: 100mg every 12hrs; ≥40kg: 200mg every 12hrs; treat for at least 14 days and for at least 7 days after symptoms resolve. Concomitant efavirenz: increase voriconazole dose to 400mg every 12hrs and decrease efavirenz dose to 300mg every 24hrs. Concomitant phenytoin: increase voriconazole dose. Hepatic impairment (mild to moderate): reduce maintenance dose by ½, (severe): see full labeling. Renal impairment (CrCl <50mL/min): oral forms preferred. Duration of therapy, and for dose adjustments if not tolerated: see full labeling.
<12yrs: not established.
Concomitant terfenadine, astemizole, cisapride, pimozide, quinidine, sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates, ergot alkaloids, St. John's wort, efavirenz ≥400mg every 24hrs (adjusted dose may be used; see Adult dose), ritonavir 400mg every 12hrs.
Correct electrolyte disturbances before and during treatment. Monitor liver function at baseline, at least weekly for the first month, then monthly thereafter; consider discontinuing if LFTs markedly elevated. Monitor renal function. Proarrhythmic conditions. Monitor visual function if used >28 days. Risk factors for acute pancreatitis (eg, recent chemotherapy, HSCT); monitor. Discontinue if serious skin reactions, squamous cell carcinoma, melanoma, or skeletal adverse events occur. Avoid direct sunlight. Tabs: galactose intolerance. Embryo-fetal toxicity; use effective contraception. Pregnancy. Nursing mothers.
See Contraindications. Potentiates cyclosporine, tacrolimus, phenytoin, coumarin anticoagulants, methadone, other CYP3A4, CYP2C9, or CYP2C19 substrates (eg, triazolam, midazolam, alprazolam, vinca alkaloids, statins, NNRTIs, calcium channel blockers, omeprazole, sulfonylureas). Antagonized by phenobarbital, phenytoin, possibly delavirdine, efavirenz 300mg every 24hrs, other CYP3A4 inducers. Concomitant everolimus, fluconazole: not recommended. Avoid concomitant ritonavir 100mg every 12hrs. Monitor levels and/or effects of cyclosporine, tacrolimus, phenytoin, warfarin, sulfonylureas, HIV protease inhibitors, NNRTIs, vinca alkaloids, statins, oral contraceptives, NSAIDs; may need dose adjustments. IV: do not infuse with concomitant blood product or short-term infusion of concentrated electrolytes.
Visual disturbances, fever, nausea, vomiting, rash (eg, Stevens-Johnson syndrome), chills, headache, increased LFTs, tachycardia, hallucinations; infusion reactions.
Tabs—30; Susp—75mL (w. dispenser); Vials—1
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