Ortrex® Voriconazole 200mg tablets
FULL PRESCRIBING INFORMATION - USE IN SPECIFIC POPULATIONS

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Taj Pharma India Brands
Taj Pharma Group (India)
P.O. Box No. 12002,
Azad Nagar Post office,
Andheri (w), Mumbai - 400 053.
India.
E-mail: ortrex@tajpharma.com
Ortrex (Voriconazole)
ORTREX® (voriconazole) Tablets 200mg Consumer information about the medication VORICONAZOLE - ORAL (Ortrex) includes side effects drug interactions recommended dosages and storage information. Read more about the prescription drug VORICONAZOLE - ORAL. Ortrex - Indication-specific dosing for Ortrex (voriconazole) frequency-based adverse effects comprehensive interactions contraindications pregnancy & lactation schedules and cost information. Fungal infections within the body sometimes occur. You are more at risk of developing an internal fungal infection if your immune system does not work Find patient medical information for voriconazole oral on WebMD including its uses side effects and safety interactions pictures warnings and user ratings Learn about the prescription medication Ortrex (Voriconazole) drug uses dosage side effects drug interactions warnings reviews and patient labeling Voriconazole is used to treat serious fungal infections such as invasive aspergillosis (a fungal infection Indication-specific dosing for Ortrex (voriconazole) frequency-based adverse effects comprehensive interactions contraindications pregnancy ORTREX safely and effectively. See full prescribing information for ORTREX. ORTREX® (voriconazole) Tablets Oral Suspension and I.V.. Initial U.S. Approval: 2002 Guidelines for Use of Voriconazole (Ortrex) Easy to read patient leaflet for voriconazole tablets Voriconazole (Ortrex) manufacturer Voriconazole (Ortrex) supplier Voriconazole (Ortrex) export Voriconazole (Ortrex) import Voriconazole (Ortrex) trader Voriconazole (Ortrex) Generic Manufacturer Voriconazole (Ortrex) manufacturing possibilities Voriconazole (Ortrex) active ingredients Voriconazole (Ortrex) medicine Voriconazole (Ortrex) health Voriconazole (Ortrex) uses Voriconazole (Ortrex) trials Voriconazole (Ortrex) manufacturing Voriconazole (Ortrex) India Voriconazole (Ortrex) trading Voriconazole (Ortrex) product Voriconazole (Ortrex) supplier Voriconazole (Ortrex) supple Voriconazole (Ortrex) suppliers Voriconazole (Ortrex) vendor Voriconazole (Ortrex) vendors Voriconazole (Ortrex) price Voriconazole (Ortrex) prices Voriconazole(Ortrex) 200mg tablets Voriconazole 200mg tablets voriconazole oral effectiveness satisfaction ease of use medication medications medicine drug drugs prescription drugs user ratings drug ratings drug reviews rate a drug treatment side effects drug interactions drug information medical information medical advice warnings overdose drug images over the counter indications precautions Ortrex Voriconazole voriconazole oral Ortrex voriconazole Ortrex voriconazole (Ortrex) side effects voriconazole (Ortrex) interactions voriconazole (Ortrex) dosing fungal lung infections antifungal drugs aspergillosis internal fungal infection ORTREX (voriconazole) tablet film coated [Cardinal Health] Voriconazole Product-Specific Bioequivalence Guidance voriconazole oral: Uses Side Effects Interactions Pictures voriconazole price voriconazole side effects voriconazole tablets voriconazole injection voriconazole eye drops voriconazole dose voriconazole mechanism of action voriconazole dose in children voriconazole tablets india voriconazole tablets Taj Pharma side effects of voriconazole tablets voriconazole side effects voriconazole used voriconazole facts voriconazole api voriconazole treatment voriconazole iv cost voriconazole mucor.

USE IN SPECIFIC POPULATIONS

Pregnancy

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].

Animal Data

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.

Nursing Mothers

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.

Pediatric Use

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.

Geriatric Use

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.

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