The recommended dose of 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: SIDAPVIA should not be used in patients with an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 (see Precautions and Pharmacology: Pharmacokinetics under Actions). Renal function should be evaluated prior to initiation of SIDAPVIA and periodically thereafter. For patients with eGFR <45 mL/min/1.73 m2 requiring sitagliptin dosage adjustment, the use of individual mono-components at the appropriate dose or alternative therapeutic agents should be considered.
Hepatic impairment: SIDAPVIA may be used in patients with mild to moderate hepatic impairment. SIDAPVIA should not be used in patients with severe hepatic impairment (see Precautions).
Use in the elderly: 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).
Paediatric and adolescent: 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.
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