Direct Healthcare Professional Communication (DHPC) on L-Thyroxin Aristo (levothyroxine sodium): Tablets in new composition - information and close monitoring of patients during the switch
2023.07.17
Active substance: levothyroxin sodium
Aristo Pharma GmbH informs in coordination with the Federal Institute for Drugs and Medical Devices (BfArM) that a new composition of L-thyroxine Aristo tablets will be available from August 2023.
The new composition provides improved stability of the active ingredient levothyroxine sodium throughout the entire life of the drug. The excipient corn starch has been added. The active ingredient levothyroxine sodium is unchanged. The route of administration and control of L-thyroxine Aristo is unchanged. In patients switching to L-Thyroxine Aristo tablets in the new composition, close monitoring is recommended, as changes in thyroid metabolism may occur due to the narrow therapeutic window of levothyroxine.
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