Posology: The recommended dose of Dapagliflozin/sitagliptin (Sidapvia) is one dapagliflozin 10 mg/sitagliptin 100 mg tablet taken orally once daily at any time of the day, with or without food.
The tablet is to be swallowed whole.
Special Populations: Renal impairment: Dapagliflozin/sitagliptin (Sidapvia) should not be used in patients with an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 (see Pharmacology: Pharmacokinetics under Actions). Renal function should be evaluated prior to initiation of Dapagliflozin/sitagliptin (Sidapvia) and periodically thereafter.
Hepatic impairment: Dapagliflozin/sitagliptin (Sidapvia) may be used in patients with mild to moderate hepatic impairment. There is limited experience in patients with severe hepatic impairment, therefore, care should be exercised when Dapagliflozin/sitagliptin (Sidapvia) is used in this population (see Pharmacology: Pharmacokinetics under Actions).
Paediatric and adolescent patients: Dapagliflozin/sitagliptin (Sidapvia) is not indicated for use in paediatric and adolescent patients. Dapagliflozin and sitagliptin have not been studied in paediatric patients under 10 years of age. Sitagliptin should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy.
Elderly patients: Dapagliflozin/sitagliptin (Sidapvia) may be used in elderly patients. However, older patients are more likely to have impaired renal function. The renal function recommendations provided for all patients also apply to elderly patients (see Precautions).
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