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Xigduo XR Dosage

Generic name: DAPAGLIFLOZIN PROPANEDIOL 10mg, METFORMIN HYDROCHLORIDE 500mg
Dosage form: tablet, film coated, extended release
Drug class: Antidiabetic combinations

Medically reviewed by Drugs.com. Last updated on Apr 12, 2022.

Prior to Initiation of XIGDUO XR

Assess renal function before initiating XIGDUO XR therapy and periodically thereafter [see Warnings and Precautions (5.1, 5.3)].
Assess volume status and, if necessary, correct volume depletion prior to initiation of XIGDUO XR [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5, 8.6)].

Recommended Administration

Take XIGDUO XR orally once daily in the morning with food.
Swallow XIGDUO XR tablets whole and never crush, cut, or chew.

2.3 Recommended Dosage

Individualize the starting dose of XIGDUO XR based upon the patient’s current regimen. Patients taking an evening dose of metformin extended-release should skip their last dose before starting XIGDUO XR.
To improve glycemic control in patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily.
For indications related to heart failure and chronic kidney disease the recommended dose for dapagliflozin is 10 mg once daily.
Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 10 mg dapagliflozin and 2,000 mg metformin hydrochloride (HCl) extended-release.

Patients with Renal Impairment

No dose adjustment for XIGDUO XR is needed in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2.
Initiation of XIGDUO XR is not recommended in patients with an eGFR between 30 and 45 mL/min/1.73 m2. Assess the benefit and risk of continuing therapy if eGFR falls persistently below this level.
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Dapagliflozin is likely to be ineffective to improve glycemic control in patients with eGFR less than 45 mL/min/1.73 m2.
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Metformin initiation is not recommended for patients with eGFR less than 45 mL/min/1.73 m2.
XIGDUO XR is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2, end-stage renal disease, or on dialysis due to the metformin component [see Contraindications (4), Warnings and Precautions (5.1, 5.2), and Use in Specific Populations (8.6)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue XIGDUO XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart XIGDUO XR if renal function is stable [see Warnings and Precautions (5.1)].

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.