Vorifast | 50 mg Tablet
Price: 0.00Generic: Voriconazole
Manufactured By: Healthcare Pharmaceuticals Ltd.Variant: Tablet 100 mg, Tablet 200 mg, Powder For Suspension 4 gm/100 ml
Composition
Vorifast 200 Tablet: Each Tablet contains Voriconazole USP 200 mg.
Vorifast 50 Tablet: Each Tablet contains Voriconazole USP 50 mg.
Pharmacology
Voriconazole is a triazole antifungal agent. Its primary mode of action is the inhibition of fungal cytochrome P-450-mediated 14α-lanosterol demethylation, an essential step in ergosterol biosynthesis. Voriconazole is more selective than some other azole drugs for fungus as opposed to various mammalian cytochrome P-450 enzyme systems. The subsequent loss of normal sterols correlates with the accumulation of 14 α-methyl sterols in fungi and may be responsible for its fungistatic/fungicidal activity.
Indication
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of following fungal infections:
● Invasive aspergillosis
● Candidemia in non-neutropenics and other deep tissue Candida infections
● Esophageal candidiasis
● Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy.
Dosage and Administration
Voriconazole Tablet is to be taken at least one hour before or one hour following a meal.
For Patients 40 kg or above:
Loading Dose: 400 mg twice daily (for the first 24 hours)
Maintenance Dose: 200 mg twice daily (from the 2nd day)
For Patients less than 40 kg:
Loading Dose: 200 mg twice daily (for the first 24 hours)
Maintenance Dose: 100 mg or 150 mg twice daily (from the 2nd day)
Dosage Adjustment:
If patient (adult) response is inadequate, the oral maintenance dose may be increased from 200 mg to 300 mg every 12 hours. For adult patients weighing less than 40 kg, the oral maintenance dose may be increased from 100 mg to 150 mg every 12 hours. If patients are unable to tolerate 300 mg orally every 12 hours, reduce the oral maintenance dose by 50 mg steps to a minimum of 200 mg every 12 hours (or to 100 mg every 12 hours for adult patients weighing less than 40 kg). Treatment duration depends upon patients’ clinical and mycological response.
Contraindication
In patients with known hypersensitivity to Voriconazole or to any of the excipients. Coadministration of CYP3A4 substrates, Terfenadine, Astemizole, Cisapride, Pimozide or Quinidine, Sirolimus, Rifampin, Carbamazepine and long-acting barbiturates, high-dose Ritonavir (400 mg Q12h), Rifabutin, Ergot alkaloids, St. John’s Wort with Voriconazole is also contraindicated.
Side effect
The most frequently reported adverse events in the therapeutic trials were visual disturbances, fever, rash, vomiting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal pain, and respiratory disorder. The treatment-related adverse events which most often led to discontinuation of Voriconazole therapy were elevated liver function tests, rash, and visual disturbances.
Drug interaction
Voriconazole is metabolized by the human hepatic cytochrome P450 enzymes CYP2C19, CYP2C9, and CYP3A4. Results of in vitro metabolism studies indicate that the unity of Voriconazole is highest for CYP2C19, followed by CYP2C9, and is appreciably lower for CYP3A4. Inhibitors or inducers of these three enzymes may increase or decrease the plasma concentration of Voriconazole respectively.
Pregnancy & Lactation
Voriconazole can cause fetal harm when administered to a pregnant woman. It is not known whether Voriconazole is excreted in the milk of laboratory animals or in human breast milk. Voriconazole must not be used in nursing mothers unless the benefit clearly outweighs the risk.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years has not been established. Therefore, Voriconazole is not recommended for pediatric patients less than 2 years of age.
Geriatric Use
No dose adjustment is necessary for geriatric patients.
Storage condition
Store below 30ºC, protect from light & moisture. Keep all medicines out of the reach of children.
How supplied
Vorifast 200 Tablet: Each pack contains 10 Tablets (in Alu-PVC Blister)
Vorifast 50 Tablet: Each pack contains 10 Tablets (in-PVC Blister)