FDA Warns of Potential Dosing Errors With Oseltamivir
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FDA Warns of Potential Dosing Errors With Oseltamivir

ROCKVILLE, Md -- September 25, 2009 -- The US Food and Drug Administration (FDA) issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with oseltamivir (Tamiflu) for Oral Suspension.

US healthcare providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while oseltamivir is dosed in milligrams (mg). The dosing dispenser packaged with oseltamivir has markings only in 30, 45, and 60 mg.

The FDA has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.

Healthcare providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.

· If prescription instructions specify administration using mg, as per the approved dosing recommendations, then the device included in the oseltamivir product package should be provided to patients and the prescription label should provide dosing instructions in mg.
· For patients prescribed a 75 mg dose, healthcare providers should counsel patients that to deliver the full dose, the oral dispenser should first be filled to 45 mg and given to the patient, then refilled to 30 mg to give the remainder of the dose.
· If prescription instructions specify administration using mL or teaspoons (tsp), then the device included in the oseltamivir product package should be removed and replaced with an appropriate measuring device, such as an oral syringe if the prescribed dose is in mL.

SOURCE: US Food and Drug Administration

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