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 Sep 12, 2023.
Prior to Initiation of XIGDUO XR
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- Assess renal function before initiating XIGDUO XR therapy and periodically thereafter [see Warnings and Precautions (5.1, 5.3)].
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- Assess volume status. In patients with volume depletion, correct this condition before initiating XIGDUO XR [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5, 8.6)].
Recommended Administration
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- Take XIGDUO XR orally once daily in the morning with food.
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- Swallow XIGDUO XR tablets whole and never crush, cut, or chew.
Recommended Dosage
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- 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.
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- To improve glycemic control in patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily.
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- For indications related to heart failure and chronic kidney disease the recommended dose for dapagliflozin is 10 mg once daily.
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- 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
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- 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.
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- 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.
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- 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)].
2.6 Temporary Interruption for Surgery
Withhold XIGDUO XR for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume XIGDUO XR when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].
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