Vanazole

Vanazole

voriconazole

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma

Marketer:

Atlantic Pharma
Concise Prescribing Info
Contents
Voriconazole
Indications/Uses
Invasive aspergillosis; esophageal candidiasis; candidemia in non-neutropenic patients; disseminated Candida infections of the skin & viscera; serious fungal infections caused by Scedosporium apiospermum & Fusarium spp (including Fusarium solani) in patients intolerant of, or refractory to, other therapy.
Dosage/Direction for Use
Adult & adolescent Loading dose (first 24 hr): >40 kg 400 mg every 12 hr, <40 kg 200 mg every 12 hr. Maintenance dose: >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. Duration of treatment: Min of 14 days & continued for at least 7 days after resolution of symptoms. Concomitant use w/ CYP450 enzyme inducers or substrates: Efavirenz Increase maintenance dose to 400 mg every 12 hr & reduce efavirenz to 300 mg once daily. Phenytoin Increase dose to 400 mg every 12 hr in patients ≥40 kg or 200 mg every 12 hr in patients <40 kg. Mild to moderate hepatic dysfunction (Child-Pugh Class A & B) Follow standard & loading dose, then reduce maintenance dosage by 50%.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or after meal.
Contraindications
Hypersensitivity. Coadministration w/ CYP3A4 substrates (eg, cisapride, pimozide or quinidine), barbiturates (long acting), carbamazepine, efavirenz, ergot derivatives, rifampin, rifabutin, ritonavir, sirolimus, St. John's wort.
Special Precautions
Visual changes. Preexisting hepatic impairment. Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. Patients receiving concomitant nephrotoxic medications. Concomitant use w/ strong CYP450 inducers; CYP2C9 inhibitors, & major 3A4 substrates. Patients w/ comorbidities &/or risk factors eg, prior cardiotoxic chemotherapy, cardiomyopathy, electrolyte imbalance or concomitant QTc-prolonging drugs. Correct electrolyte abnormalities (eg, hypokalemia, hypomagnesemia, hypocalcemia) prior to therapy. Avoid strong direct exposure to sunlight. Photosensitivity in long-term use. Discontinue use in patients who develop an exfoliative cutaneous reaction or a skin lesion consistent w/ squamous cell carcinoma or melanoma. Perform periodic total body skin exam in prolonged use. Monitor pancreatic function in patients at risk of acute pancreatitis. Avoid task that depend on vision, including operating machinery or driving. Women of potential childbearing should use effective contraception during treatment. Pregnancy & lactation.
Adverse Reactions
Nausea, vomiting, abdominal pain, diarrhea, jaundice, oedema, hypotension, chest pain, resp distress syndrome, sinusitis, headache, dizziness, asthenia, anxiety, depression, confusion, agitation, hallucinations, paresthesia, tremor, influenza-like symptoms, hypoglycemia, hematuria, blood disorders (eg, anemia, thrombocytopenia, leucopenia, pancytopenia), acute renal failure, hypokalemia, visual disturbances (eg, altered perception, blurred vision & photophobia), rash, pruritus, photosensitivity, alopecia, cheilitis.
Drug Interactions
Potentially increase systemic exposure of other drugs metabolized by CYP450 enzymes. Barbiturates (long acting), cimetidine, fluconazole, hormonal contraceptives, NNRTIs, phenytoin, PIs, proton-pump inhibitors, rifampin, rifabutin, St. John's wort. Aripiprazole, benzodiazepines, cabazitaxel, Ca channel blockers, cisapride, clopidogrel, coumarin anticoagulants, cyclosporine, docetaxel, dronedarone, ergot alkaloids, erlotinib, erythromycin, HMG-CoA reductase inhibitors, ixabepilone, maraviroc, everolimus, temsirolimus, nilotinib, NSAIDs, opioid analgesics, pimozide, quinidine, romidepsin, sirolimus, sulfonylureas, tacrolimus, tyrosine kinase receptor inhibitors, vinca alkaloids, zolpidem.
MIMS Class
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Vanazole FC tab 200 mg
Packing/Price
3 × 10's
Form
Vanazole FC tab 50 mg
Packing/Price
3 × 10's
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