Actual Medicinal Product (AMP) Pradaxa 110mg capsules (CST Pharma Ltd)

Stability Information

(Some stability information inherited from generic)

Stability: Lack of data and/or stability concerns exist. MCA use may be acceptable but is likely to be off-label and require mitigation measures. Keep medicines in MCAs for the shortest time necessary. Generally, up to 5 weeks maximum unless otherwise specified, or up to 8 weeks if the MCA is airtight (sealed). Consider the risk of potency loss or dose variability and monitor for changes in efficacy or adverse effects after MCA initiation.
Notes: Do not remove the capsule from the aluminium foil. Capsules in its aluminium foil can be placed in an MCA. Decision to do this depends on patient/carer understanding to remove the capsule from foil packaging before administering. Moisture sensitive medicine. Store in airtight (sealed) MCA. A 7-day compliance aid specific for Pradaxa capsules is available from Boehringer Ingelheim Limited.
Provenance: This recommendation is based on the products Pradaxa 110mg hard capsules (Boehringer Ingelheim Limited) and dabigatran etexilate 110mg hard capsules (Glenmark Pharmaceuticals Europe Ltd).
Generic: Dabigatran etexilate
Formulation: Dabigatran etexilate 110mg capsules