Vori 50

Indications

Vori stands as an azole antifungal remedy, recommended for individuals aged 12 and above to address various fungal infections, including:

• Invasive aspergillosis
• Candidemia (nonneutropenic) and disseminated candidiasis affecting skin, abdomen, kidney, bladder wall, and wounds
• Esophageal candidiasis
• Serious infections caused by Scedosporium apiospermum and Fusarium Species, encompassing Fusarium solani
• For patients intolerant of, or refractory to other therapies.

Pharmacology

Voriconazole, belonging to the triazole class of antifungal medications, is employed to tackle severe fungal infections. By binding and inhibiting ergosterol synthesis via CYP450-dependent 14-alpha sterol demethylase inhibition, voriconazole effectively depletes ergosterol in fungal cell membranes.

Dosage & Administration

Oral Administration:

• Voriconazole tablets and powder for suspension should be taken at least one hour before or after a meal.
• For individuals weighing 40 kg or more: The loading dose regimen is 400 mg or 10 ml every 12 hours for the initial 24 hours, followed by a maintenance dose of 200 mg or 5 ml twice daily.
• For individuals weighing below 40 kg: The loading dose regimen is 200 mg or 5 ml every 12 hours for the first 24 hours, followed by a maintenance dose of 100 mg or 2.5 ml twice daily. Alternatively, follow the physician’s instructions.

Injection Administration:

• Invasive Aspergillosis:
  • Loading dose: 6 mg/kg every 12 hours for the initial 24 hours.
  • Maintenance Dose: 4 mg/kg every 12 hours.
• Candidemia in nonneutropenic patients and other deep tissue Candida infections:
  • Loading dose: 6 mg/kg every 12 hours for the initial 24 hours.
  • Maintenance Dose: 3-4 mg/kg every 12 hours.
• Scedosporiosis and Fusariosis:
  • Loading dose: 6 mg/kg every 12 hours for the initial 24 hours.
  • Maintenance Dose: 4 mg/kg every 12 hours.

Interaction

Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy in the presence of CYP3A4, CYP2C9, and CYP2C19 inhibitors and inducers. Voriconazole may increase the concentrations and activity of drugs that are substrates of CYP3A4, CYP2C9, and CYP2C19. Reduce doses of these other drugs and monitor for adverse reactions. Increase maintenance oral and intravenous dosage of Voriconazole with the co-administration of Phenytoin or Efavirenz.

Contraindications

Avoid Voriconazole in individuals with known hypersensitivity to it or any other components of the drug. Avoid co-administration with terfenadine, astemizole, cisapride, pimozide, or quinidine, sirolimus due to the risk of serious adverse reactions. Also, avoid co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids, and St. John’s Wort due to the risk of loss of efficacy.

Side Effects

Common side effects may include abdominal pain, anemia, blurred vision, headache, chest pain, nausea, and diarrhea.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. Voriconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

Long-term exposure (treatment or prophylaxis) exceeding 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation to long-term Voriconazole treatment.

Use in Special Populations

The efficacy in children under 12 years of age is not established.

Overdose Effects

No data regarding the overdose effects of Voriconazole is available.

Therapeutic Class

Voriconazole belongs to the class of Other Antifungal preparations.

Reconstitution

For suspension reconstitution: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until the powder is completely mixed with the water. Store reconstituted suspension between 15°C-30°C. Discard suspension 14 days after reconstitution.

Storage Conditions

Keep out of reach of children. Store in a dry place, below 25°C, and protected from light. Store Voriconazole powder for suspension between 2°C to 8°C.