Specific Syringe for Use with U-500 Insulin Vials FDA-Approved

New device no longer requires dose conversions
New device no longer requires dose conversions

The Food and Drug Administration (FDA) has approved a specific syringe for the administration of Humulin R U-500 (regular insulin [human, rDNA origin]).  

Since 1994, there has been no dedicated delivery device for Humulin R U-500 insulin vials. Healthcare practitioners and patients had to convert the doses to deliver the appropriate strength using a U-100 insulin syringe or a tuberculin (volumetric) syringe. The new device no longer requires dose conversions.

The syringes approved for use with Humulin R U-500 insulin vials will be available via a prescription only and should be prescribed together with U-500 insulin

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The Humulin R U-500 insulin vial labeling will be updated to reflect the removal of the dose conversion information for U-100 and tuberculin syringes. Humulin R U-500 is already available as a prefilled pen device as well as the vial. Patients who are hospitalized or who are in transition of care should have their dose of Humulin R U-500 accurately communicated to the hospital staff. 

Also, patients should not switch between the syringe types because it may increase the risk of dosing errors. If they run out of their supply of U-500 syringes, they should contact their pharmacist or healthcare professional and not try to dose with another type. 

For more information call (888) 463-6332 or visit FDA.gov.

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