Zemidapa Dosage/Direction for Use

Posology: Adults: The recommended dose is one tablet once daily in patients who need 50 mg of gemigliptin and 10 mg of dapagliflozin.
Special populations: Renal impairment: The efficacy and safety of Gemigliptin/Dapagliflozin is dependent on renal function, and renal function should be evaluated prior to initiation of Gemigliptin/Dapagliflozin and periodically thereafter.
For patients with eGFR ≥45 mL/min/1.73 m², no dose adjustment is required.
For patients with eGFR <45 mL/min/1.73 m², Gemigliptin/Dapagliflozin is not recommended.
Hepatic impairment: No dose adjustment is required for patient with mild or moderate hepatic impairment. The safety and efficacy of Gemigliptin/Dapagliflozin in patients with severe hepatic impairment have not yet been established.
Cardiac impairment: There is limited experience in patients with New York Heart Association (NYHA) Class I, II cardiac status in the case of gemigliptin. Therefore, Gemigliptin/Dapagliflozin should be used with caution in this population. Due to limited clinical experience in patients with NYHA Class III, IV cardiac status in the case of gemigliptin, the use of Gemigliptin/Dapagliflozin is not recommended in this population (see Precautions).
Elderly: Caution should be used in elderly patient because physiological functions including liver and kidney are usually decreased in this population.
Pediatric population: Safety and effectiveness in children and adolescents below 18 years of age have not been established. No data are available.
Method of administration: Gemigliptin/Dapagliflozin can be taken once daily with or without food.