VORIF TABLETS

Composition:

Each filmcoated tablet contains Voriconazole 50mg and 200mg respectively

Ferozsons Specifications:

Drug Description VORIF TABLETS:

Voriconazole is a triazole antifungal agent with the chemical designation (2R,3S)2(2,4difluorophenyl)3(5fluoro4pyrimidinyl)1(1H1,2,4triazol1yl)2butanol It inhibits fungal cytochrome P450mediated 14 alphalanosterol demethylation, a crucial step in fungal ergosterol biosynthesis

Clinical Pharmacology:

Mode of Action: Inhibition of fungal cytochrome P450 enzymes VORIF TABLETS

Pharmacodynamics/Kinetics: Well absorbed orally, selective for fungal cytochrome P450, hepatic metabolism, bioavailability of 96%, variable elimination half life

Indications: Invasive aspergillosis, esophageal candidiasis, candidemia, disseminated Candida infections, serious fungal infections caused by specific species

Dosage and Administration:

Loading Dose (First 24 hours):

Patients 40kg and above: 400mg every 12 hours

Patients less than 40kg: 200mg every 12 hours

Maintenance Dose (After the first 24 hours):

Patients 40kg and above: 200mg twice a day

Patients less than 40kg: 100mg twice a day

Recommended Duration: Minimum of 14 days, with at least 7 days post symptom resolution

Dosing in Special Populations:

Renal Insufficiency: No dose adjustment necessary

Hepatic Impairment: Reduce maintenance dosage by 50% in mild to moderate cases; caution in severe impairment

Elderly: Follow adult dosing

Teenagers 12 to 14 years (50kg or more): 400mg every 12 hours for the first 24 hours, then 200mg twice a day

Adverse Reactions:

Common (210%): Hypokalemia, visual changes, fever, nausea

<2% (Important or life threatening): Acute tubular necrosis, pancreatitis, respiratory distress syndrome, Stevens Johnson syndrome, and more

Contraindications VORIF TABLETS:

Hypersensitivity to voriconazole or its components

Co-administration with certain drugs, including rifampin, ritonavir, carbamazepine, and others

Warnings/Precautions:

Arrhythmias/QT Prolongation: Caution in patients with risk factors; correct electrolyte abnormalities

Dermatologic Reactions: Monitor for photosensitivity; discontinue for severe reactions

Hallucinations: Mostly with IV formulation; caution is advised

Pregnancy and Lactation:

Pregnancy Risk Factor: D (Benefit to mother justifies potential risk to the fetus)

Excretion in breast milk is unknown; not recommended during lactation

Drug Interactions:

Contraindicated with drugs like rifampin, ritonavir, carbamazepine, etc

Significant interactions with fluconazole, cimetidine, ranitidine, and others; dosage adjustment may be necessary

Storage:

Store at 1530 °C in a dry and dark place Keep out of the reach of children

How Supplied:

Vorif 50mg & 200mg Tablets are available in 1x10's Blister Pack

Please read the contents cautiously before use This package insert is regularly and timely updated