Special Storage and Handling Requirement for Pradaxa

Drug Alerts , News / September 21, 2016

The FDA is advising the public on important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules.  Due to the possibility of product breakdown from moisture and loss of potency, Pradaxa capsules should only be dispensed and stored in the original bottle or blister package.

Pradaxa is an anticoagulant (blood thinner) medication known as a direct thrombin inhibitor. While the Pradaxa label and Medication Guide already contain information about these special storage and handling requirements, the FDA is concerned that these requirements are not commonly known and followed by Pradaxa users and pharmacies.

The storage and handling requirements are as follow:

  • Pharmacists should only dispense Pradaxa in the original manufacturer bottle with the original dessicant cap.
  • Pradaxa is not to be repackaged in standard amber pharmacy vials.
  • Patients should not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers.
  • Only one bottle of Pradaxa is to be opened at a time.
  • Currently, the approved Pradaxa label states that once opened, the product must be used within 30 days. The FDA is reviewing data that indicates no significance loss of potency up to 60 days after the bottle has been opened as long as Pradaxa is stored in the original bottle and the handling requirements are met.

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