Xigduo XR Dosage

Testing Prior to Initiation of XIGDUO XR

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Assess renal function prior to initiating XIGDUO XR and then as clinically indicated.

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Assess volume status. In patients with volume depletion, correct this condition before initiating XIGDUO XR.

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 dosage of XIGDUO XR based upon the patient’s current regimen. Patients taking an evening dosage of metformin HCl extended‑release should skip their last dose before starting XIGDUO XR.

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​To improve glycemic control in adults and pediatric patients aged 10 years and older not already taking:

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Dapagliflozin: the recommended starting dosage of dapagliflozin in XIGDUO XR is 5 mg orally once daily.

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Metformin HCl extended‑release: the recommended starting dosage of metformin HCl extended‑release in XIGDUO XR is 500 mg orally once daily.

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For XIGDUO XR indications in adults related to heart failure and chronic kidney disease, the recommended dosage of dapagliflozin in XIGDUO XR is 10 mg orally once daily.

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For all XIGDUO XR indications, the dosage may be adjusted based on effectiveness and tolerability. The maximum recommended daily dosage of dapagliflozin is 10 mg and 2,000 mg of metformin HCl extended‑release, with gradual dosage escalation to reduce gastrointestinal adverse reactions with metformin HCl.

Recommended Dosage in Patients with Renal Impairment

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The recommended dosage of XIGDUO XR in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2 is the same as the recommended dosage in patients with normal renal function.

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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 HCl 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 and end‑stage renal disease due to the metformin HCl component.

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue XIGDUO XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 60 mL/min/1.73 m2, 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.

Temporary Interruption for Surgery

Withhold XIGDUO XR for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume XIGDUO XR when the patient is clinically stable and has resumed oral intake.