Xigduo XR Dosage/Direction for Use

The dosage of antihyperglycaemic therapy with XIGDUO XR should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended dose of dapagliflozin 10 mg and metformin extended-release 2000 mg.
XIGDUO XR should generally be administered once daily with the evening meal. The following tablet strengths are available: XIGDUO XR Tablet 10mg/1000mg (dapagliflozin 10 mg/metformin HCl extended-release 1000 mg); XIGDUO XR Tablet 5mg/1000mg (dapagliflozin 5 mg/metformin HCl extended-release 1000 mg).
Initial therapy: If therapy with a combination tablet containing dapagliflozin and metformin is considered appropriate, the recommended dose of dapagliflozin is 10 mg once daily. The recommended starting dose of metformin extended-release is 500 mg once daily, which can be titrated to 2000 mg once daily. The maximum dose of XIGDUO XR is dapagliflozin 10 mg/metformin extended-release 2000 mg taken as two 5 mg/1000 mg tablets once daily.
Add on combination therapy: In patients treated with metformin, the dose of XIGDUO XR should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Following a switch from metformin immediate-release to metformin extended-release, glycaemic control should be monitored closely and dosage adjustments made accordingly.
When dapagliflozin is used as an add-on therapy with insulin or an insulin secretagogue, a lower dose of insulin or an insulin secretagogue may be considered to reduce the risk of hypoglycaemia.
No studies have been performed specifically examining the safety and efficacy of XIGDUO XR in patients previously treated with other antihyperglycaemic agents and switched to XIGDUO XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycaemic control can occur.
If no adequate strength of XIGDUO XR is available, individual mono-components should be used instead of the fixed dose combination.
Patients should be informed that XIGDUO XR tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of XIGDUO XR will be eliminated in the faeces as a soft, hydrated mass that may resemble the original tablet.
Renal Impairment: Assess renal function prior to initiation of XIGDUO XR and periodically thereafter (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Factors that may increase the risk of lactic acidosis (see Precautions) should be reviewed before considering initiation of metformin in patients with eGFR < 60 mL mL/min/1.73 m².
Mild renal impairment: No dose adjustment of XIGDUO XR is required for patients with mild renal impairment (estimated glomerular filtration [eGFR] 60-89 mL/min/1.73 m² by Modified Diet in Renal Disease [MDRD] eGFR equation).
Moderate renal impairment: No dose adjustment is required for patients with eGFR ≥ 45 mL/min/1.73 m². XIGDUO XR is contraindicated in patients with eGFR persistently below 45 mL/min/1.73 m² (see Contraindications and Precautions).
Severe renal impairment: XIGDUO XR is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) (see Contraindications). (See Table 11.)

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Hepatic Impairment: Since impaired hepatic function has been associated with some cases of lactic acidosis in patients taking metformin, XIGDUO XR should not be used in patients with clinical or laboratory evidence of hepatic impairment. (See Hepatic Impairment under Precautions).
Paediatric and Adolescent: Safety and effectiveness of XIGDUO XR in paediatric and adolescent patients have not been established.
Use in the Elderly: Because metformin is eliminated by the kidney, and because elderly patients are more likely to have decreased renal function, XIGDUO XR should be used with caution as age increases.