Xigduo XR Dosage/Direction for Use

Dapagliflozin/metformin HCl extended-release tablets: Dapagliflozin/Metformin HCl (XIGDUO XR) should be taken orally, once daily with the evening meal.
The recommended dose of dapagliflozin is 10 mg once daily. The recommended starting dose of metformin is 500 mg once daily, which can be titrated to 2000 mg once daily, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.
In patients treated with metformin, the dose of Dapagliflozin/Metformin HCl (XIGDUO XR) should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose.
If no adequate strength of Dapagliflozin/Metformin HCl (XIGDUO XR) is available, individual mono-components should be used instead of fixed dose combination.
Patients should be informed that Dapagliflozin/Metformin HCl (XIGDUO XR) tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of Dapagliflozin/Metformin HCl (XIGDUO XR) will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet.
Special Populations: Patients with Renal Impairment: Assess renal function prior to initiation of Dapagliflozin/Metformin HCl (XIGDUO XR) and periodically thereafter (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Mild renal impairment: No dose adjustment of Dapagliflozin/Metformin HCl (XIGDUO XR) is required for patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m² by Modified Diet in Renal Disease [MDRD] eGFR equation).
Moderate Renal Impairment: Dapagliflozin/Metformin HCl (XIGDUO XR) is not recommended for the treatment of diabetes in patients with eGFR persistently below 45 mL/min/1.73 m² (see Precautions). No dose adjustment is required for patients with eGFR ≥ 45 mL/min/1.73 m².
Severe renal impairment: Due to the metformin component, Dapagliflozin/Metformin HCl (XIGDUO XR) is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) (see Contraindications).
Patients with Hepatic Impairment: Since impaired hepatic function has been associated with some cases of lactic acidosis in patients taking metformin, Dapagliflozin/Metformin HCl (XIGDUO XR) should generally be avoided in patients with clinical or laboratory evidence of hepatic impairment (see Use in Patients with Hepatic Impairment under Precautions).
Pediatric and Adolescent patients: Safety and effectiveness of Dapagliflozin/Metformin HCl (XIGDUO XR) in pediatric and adolescent patients have not been established.
Elderly patients: Because metformin is eliminated by the kidney, and because elderly patients are more likely to have decreased renal function, Dapagliflozin/Metformin HCl (XIGDUO XR) should be used with caution as age increases. The renal function recommendations provided for all patients also apply to elderly patients. (see Precautions).
Patients at Risk for Volume Depletion: For patients at risk for volume depletion due to co-existing conditions, a 5 mg starting dose of dapagliflozin may be appropriate (see Precautions and Pharmacology: Pharmacodynamics under Actions).