Vorica

Vorica

voriconazole

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Voriconazole
Indications/Uses
Invasive aspergillosis; candidemia in non-neutropenic patients; serious invasive Candida infections including C. krusei; esophageal candidiasis; serious fungal infections caused by Scedosporium apiospermum & Fusarium sp including Fusarium solani, in patients intolerant of, or refractory to, other therapy.
Dosage/Direction for Use
IV infusion Administer at a max rate of 3 mg/kg/hr over 1-2 hr. Adult & adolescent (12-16 yr) All indications Loading dose (first 24 hr): 6 mg/kg every 12 hr. Serious invasive candida/aspergillosis/scedoporium & fusarium infections or other serious infection 4 mg/kg every 12 hr. Candidemia in non-neutropenic patients 3-4 mg/kg every 12 hr. May increase dose to 4 mg/kg every 12 hr if patient response is adequate & may reduce dose to 3 mg/kg every 12 hr if patients are unable to tolerate treatment. Co-administration w/ phenytoin Increase maintenance dose to 5 mg/kg every 12 hr. Childn 2-<12 yr Maintenance dose: 7 mg/kg twice daily. If childn are unable to tolerate treatment, reduce dose to 4 mg/kg twice daily.
Contraindications
Hypersensitivity to voriconazole or other azoles. Co-administration w/ CYP3A4 substrates eg, terfenadine, astemizole, cisapride, pimozide or quinidine; sirolimus; rifabutin, rifampin, carbamazepine & long-acting barbiturate; efavirenz (≥400 mg once daily); ritonavir (400 every 12 hr); ergot alkaloids (ergotamine & dihydroergotamine); St. John's wort.
Special Precautions
Hypersensitivity to other azoles. Not for IV bolus inj. Patients w/ potentially proarryhthmic conditions including congenital or acquired QT-prolongation; cardiomyopathy when heart failure is present; sinus bradycardia; existing symptomatic that is known to prolong QT interval. Monitor & correct electrolyte disturbances prior to initiation & during treatment. Discontinue use if anaphylactoid reactions, exfoliative cutaneous reactions, skin lesion consistent w/ squamous cell carcinoma or melanoma, & skeletal pain & radiologic findings compatible w/ periostitis develops. Carefully monitor for hepatic toxicity; abnormal renal function; pancreatitis in adult & childn during treatment. Laboratory evaluation of hepatic function (specifically AST & ALT) at the initiation of treatment & at least wkly for the 1st mth of treatment; serum creatinine. Discontinue use if liver function tests become markedly elevated. Photosensitivity skin reaction; squamous cell carcinoma of the skin & melanoma; periostitis in transplant patients w/ prolonged use. Avoid exposure to direct sunlight & use measures eg, protective clothing & sunscreen w/ high SPF during treatment. Consult a dermatologist if phototoxic reactions occur. Avoid potentially hazardous tasks including driving or operating machinery. Serious hepatic reactions during treatment. Acute renal failure. Women of childbearing potential should always use effective contraception during treatment. Not to be used during pregnancy. Discontinue breast-feeding upon initiation of treatment. Childn <12 yr.
Adverse Reactions
Peripheral oedema; headache; visual impairment; diarrhoea, vomiting, abdominal pain, nausea; abnormal liver function test; rash; pyrexia. Sinusitis; agranulocytosis, pancytopenia, thrombocytopenia, leukopenia, anaemia; hypoglycaemia, hypokalaemia; depression, hallucination, anxiety, insomnia, agitation, confusional state; syncope, tremor, hypertonia, paraesthesia, somnolence, dizziness; retinal haemorrhage; supraventricular arrhythmia, tachycardia, bradycardia; hypotension, phlebitis; acute resp distress syndrome, pulmonary oedema; cheilitis, dyspepsia, constipation, gingivitis; jaundice, cholestatic jaundice, hepatitis; exfoliative dermatitis, alopecia, maculo-papular rash, pruritus; back pain; acute renal failure, haematuria; chest pain, face oedema, asthenia, chills; increased blood creatinine.
Drug Interactions
Increased plasma conc & QTc prolongation w/ astemizole, cisapride, pimozide, quinidine & terfenadine, Ca channel blockers. Decreased plasma conc w/ carbamazepine & long-acting barbiturates (eg, phenobarb, mephobarbital). Increased plasma conc of ergot alkaloids (eg, ergotamine & dihydroergotamine) leading to ergotism; everolimus, benzodiazepenes (eg, midazolam, triazolam, alprazolam), statins, sulphonylureas (eg, tolbutamide, glipizide, glyburide), vinca alkaloids (eg, vincristine & vinblastine). Efavirenz, rifabutin, ritonavir, St. John's wort, fluconazole, phenytoin, omeprazole, OCs (norethisterone/ethinylestradiol), digoxin, indinavir, erythromycin, azithromycin, mycophenolic acid, ranitidine. Decreased AUC w/ rifampicin. Increased prothrombin time w/ warfarin & other oral coumarins (eg, phenprocoumon, acenocoumarol). Increased AUC of sirolimus, ciclosporin, tacrolimus, long acting opiates (oxycodone), methadone, NSAIDs (ibuprofen, diclofenac), short acting opiates (alfentanil, fentanyl), prenisolone. Increased AUC w/ cimetidine. May inhibit metabolism w/ HIV PIs, NNRTIs.
MIMS Class
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Vorica lyo powd for inj 200 mg
Packing/Price
1's
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