Vorimart 200 Tablet

Voriconazole USP 200mg

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

Voriconazole is a broad spectrum, triazole systemic antifungal agent.

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The primary mode of action of Voriconazole is the inhibition of fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.

Voriconazole is indicated in adults follows:
* Treatment of invasive aspergillosis.
* Treatment of candidaemia in non-neutropenic patients.
* Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
* Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possible life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Dosage and Administration
In Adults
Therapy must be initiated with the specified loading dose regimen of either intravenous or oral Voriconazole to achieve plasma concentrations on day 1 that are close to steady state. On the basis of the high oral bioavailablility (96%), switching between intravenous and oral administration is appropriate when clinically indicated.

Duration of treatment
Treatment duration should be as short as possible depending on the patient’s clinical and mycological response. Long term exposure to Voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance.
Prophylaxis in adults and children
Prophylasix should be initiated on the day of transplant and may be administered for up to 100 days. Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Dosage in special population
No dose adjustment is necessary for elderly patients.
Renal impairment
The pharmacokinetics of Voriconazole are not affected by renal impairment. Therefore, no adjustment is necessary for oral dosing for patinets with mild to severe renal impairment.
Hepatic impairment
It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving Voriconazole. Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).

In an overdose, haemodialysis may assist in the removal of Voriconazole and SBECD from the body.

Voriconazole is contraindicated in patients with known hypersensitivity to the drug or other azoles.

Warning and Precautions
Long-term treatment
Long term exposure (treatment of prophylaxis) greater than 180 days (6 months) requires careful assessment of the benefit-risk balance and physicians should therefore consider the need to limit the exposure to Voriconazole.

Side Effects
Most common adverse reactions: visual distrubances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations.

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 dosage 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 data on the use of Voriconazole in pregnant women available. Voriconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
The excreation of Voriconazole into breast milk has not been investigated.

Storage Condition
Vorimart Tablet 200mg: Store at temperature not exceeding 30C in a dry place.

Vorimart Tablet 200 mg: Each box contains 1×10’s tablets.