Vorizol

Voriconazole USP


Composition : Vorizol-50: Each film coated tablet contains Voriconazole USP 50 mg.

Vorizol-200: Each film coated tablet contains Voriconazole USP 200 mg.

Vorizol Suspension: Each 5ml powder for suspension contains Voriconazole USP 200 mg.

Indications : Vorizol is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections.

* Invasive aspergillosis

* Candidemia (nonneutropenics) and disseminated candidiasis in skin, abdomen kidney, bladder wall and wounds.

* Esophageal candidiasis

* Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani, in patients intolerant of, or refractory to, other therapy.

Dosage and Administration : Vorizol tablet and powder for suspension are to be taken at Ieast one hour before or one hour following a meal.

* At or over 40 kg body weight is loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.

* Below 40 Kg body weight is loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Reconstitution Instructions : Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoon of provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15- 30 degree celsius.

Discard suspension 14 days after reconstitution.

Side effects : The most common side effects are: abdominal pain, anaemia, blurred vision, headache, chest pain, nausea, diarrhea.

Contraindications :

* It is contraindicated in patients with known hypersensitivity to voriconazole or any other components of this drug.

* Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, cirolimus due to risk of serious adverse reactions.

* Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy.

Drug Interactions : * CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust voriconazole dosage and monitor for adverse reactions or lack of efficacy.

* Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions.

* Phenytoin or Efavirenz: with co-administration, increase maintenance oral and intravenous dosage of voriconazole.

Use in pregnancy and lactation : There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether it is excreted in human milk. So a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Packing :

Vorizol-50: Each box contains 1 x 10's tablets in blister pack.

Vorizol-200: Each box contains 1 x 7's tablets in blister pack.

Vorizol Suspension: Each bottle contains 40ml powder for suspension.

Prescribing Description

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