The FDA Center for Drug Evaluation and Research (CDER) issued a warning regarding the use of medicinal products containing dapagliflozin propanediol/metformin hydrochloride concerning interactions with lithium, insulin, or insulin secretagogues
Section “Interaction with other medicinal products”
Recently added information:
Insulin or insulin secretagogues
Clinical impact
The risk of hypoglycemia may increase with the concomitant use of medicinal products containing dapagliflozin propanediol/metformin hydrochloride with insulin or insulin secretagogues (for example, sulfonylurea) [see Warnings and Precautions].
Intervention
Concomitant use may require a reduction in the doses of insulin or agents that increase insulin secretion in order to reduce the risk of hypoglycemia.
Lithium
Clinical impact
Concomitant use of SGLT2 inhibitors with lithium may lead to a decrease in serum lithium concentration.
Intervention
Serum lithium concentration should be monitored more frequently when starting treatment with medicinal products containing dapagliflozin propanediol/metformin hydrochloride and when the dose is changed.
Guide to medical use
Recently added information:
Dapagliflozin propanediol/metformin hydrochloride may affect the action of other medicinal products, and other medicinal products may affect the action of dapagliflozin propanediol/metformin hydrochloride.
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