FULL PRESCRIBING INFORMATION - USE IN SPECIFIC POPULATIONS
Taj Pharma India Brands
Taj Pharma Group (India)
214, Bake House, Bake House Lane,
Fort, Mumbai 400001, India.
USE IN SPECIFIC POPULATIONS
Pregnancy Category D
Voriconazole can cause fetal harm when administered to a pregnant woman and should not be taken in pregnancy except in patients where the benefit to the mother clearly outweighs the potential risk to the fetus. There are no adequate and well controlled studies in pregnant women.
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patients should be informed of the potential hazard to the fetus [see Warnings and Precautions].
Voriconazole was teratogenic in rats (cleft palates, hydronephrosis/hydroureter) from 10 mg/kg (0.3 times the recommended maintenance dose (RMD) on a mg/m2 basis) and embryotoxic in rabbits at 100 mg/kg (6 times the RMD). Other effects in rats included reduced ossification of sacral and caudal vertebrae, skull, pubic and hyoid bone, supernumerary ribs, anomalies of the sternebrae and dilatation of the ureter/renal pelvis. Plasma estradiol in pregnant rats was reduced at all dose levels. Voriconazole treatment in rats produced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose. The effects seen in rabbits were an increased embryomortality, reduced fetal weight and increased incidences of skeletal variations, cervical ribs and extrasternebral ossification sites.
It is not known whether voriconazole is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from voriconazole, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
A total of 22 patients aged 12 to 18 years with invasive aspergillosis were included in the therapeutic studies. Twelve out of 22 (55%) patients had successful response after treatment with a maintenance dose of voriconazole 4 mg/kg q12h.
Sparse plasma sampling for pharmacokinetics in adolescents was conducted in the therapeutic studies [see Clinical Pharmacology ].
There have been post-marketing reports of pancreatitis in pediatric patients.
In multiple-dose therapeutic trials of voriconazole, 9.2% of patients were ≥ 65 years of age and 1.8% of patients were ≥ 75 years of age. In a study in healthy subjects, the systemic exposure (AUC) and peak plasma concentrations (Cmax) were increased in elderly males compared to young males. Pharmacokinetic data obtained from 552 patients from ten voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either IV or oral administration. However, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see Clinical Pharmacology ].
Women of Childbearing Potential
Women of childbearing potential should use effective contraception during treatment. The coadministration of voriconazole with the oral contraceptive, Ortho-Novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. Monitoring for adverse events associated with oral contraceptives and voriconazole is recommended [see Drug Interactions and Clinical Pharmacology]
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Ortrex® Voriconazole 200mg tablets are a prescription medicine used to treat certain serious fungal infections in your blood and body. Ortrex® Voriconazole 200mg tablets sold by Taj Pharmaceuticals Limited (India), a global pharmaceuticals company. It is available in India, Middle East and a few other South Asian countries. Ortrex® Voriconazole 200mg tablets_CMI Ortrex® Voriconazole 200mg tablets_FPI