FULL PRESCRIBING INFORMATION - OVERDOSAGE
Taj Pharma India Brands
Taj Pharma Group (India)
214, Bake House, Bake House Lane,
Fort, Mumbai 400001, India.
In clinical trials, there were three cases of accidental overdose. All occurred in pediatric patients who received up to 5 times the recommended intravenous dose of voriconazole. A single adverse event of photophobia of 10 minutes duration was reported.
There is no known antidote to voriconazole.
Voriconazole is hemodialyzed with clearance of 121 mL/min. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min. In an overdose, hemodialysis may assist in the removal of voriconazole and SBECD from the body.
The minimum lethal oral dose in mice and rats was 300 mg/kg (equivalent to 4 and 7 times the recommended maintenance dose (RMD), based on body surface area). At this dose, clinical signs observed in both mice and rats included salivation, mydriasis, titubation (loss of balance while moving), depressed behavior, prostration, partially closed eyes and dyspnea. Other signs in mice were convulsions, corneal opacification and swollen abdomen.
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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