The recommended dose of QTERN is one 5 mg/10 mg tablet taken once daily at any time of the day, with or without food. Tablet is to be swallowed whole.
Please refer to Precautions for information regarding combinations not studied.
Optimal medical management of patients with diabetes also involves attention to diet, exercise, blood glucose monitoring, assessment of complications and co-morbidities. Regular assessment and review of the compliance and benefit/risk of all therapies is recommended.
Special Populations: Patients with renal impairment: QTERN may be used in patients with mild renal impairment (see Precautions).
The glycaemic efficacy of dapagliflozin is dependent on renal function. Renal function should be evaluated prior to initiation of QTERN and periodically thereafter. QTERN should not be used in patients with an estimated glomerular filtration rate (eGFR) persistently < 45 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) formula or in patients with end-stage renal disease (ESRD) (see Precautions).
Patients with hepatic impairment: QTERN may be used in patients with mild or moderate hepatic impairment. QTERN should not be used in patients with severe hepatic impairment (see Precautions).
Paediatric and adolescent patients: Safety and effectiveness of QTERN in paediatric and adolescent patients (<18 years of age) have not been established.
Elderly patients: In general, no dosage adjustment is recommended based on age. Renal function and risk of volume depletion should be taken into account (see Precautions and Pharmacology under Actions). Due to the limited therapeutic experience in patients 75 years and older, initiation of QTERN therapy is not recommended in this patient group.
Patients at risk for volume depletion: In patients with volume depletion, correcting this condition prior to initiation of QTERN is recommended.