VORIF: Voriconazole Tablets (50mg & 200mg)

Composition:

VORIF TABLETS Each filmcoated
tablet contains Voriconazole 50mg and 200mg respectively

Ferozsons Specifications:

Drug Description:

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

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:

• 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