Dapagliflozindosage

Assess renal function prior to initiating and then as clinically indicated. Assess volume status and correct volume depletion before initiating. Individualize the starting dosage based on the patient’s current treatment. Administer orally once daily in the morning with food. To improve glycemic control, for patients not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. For indications in adults related to heart failure and chronic kidney disease the recommended dosage of dapagliflozin is 10 mg once daily. Do not exceed a daily dosage of 10 mg dapagliflozin/ 2,000 mg metformin HCl extended-release. See Full Prescribing Information for dosage recommendations in patients with renal impairment. Dapagliflozin and metformin HCl extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. Withhold Dapagliflozin and metformin HCl extended-release tablets for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting.

2.1 Testing

Prior to Initiation of Dapagliflozin and Metformin HCl Extended-Release Tablets Assess renal function prior to initiating dapagliflozin and metformin HCl extended-release tablets and then as clinically indicated. Assess volume status. In patients with volume depletion, correct this condition before initiating dapagliflozin and metformin HCl extended-release tablets.

2.2 Recommended

Administration Take dapagliflozin and metformin HCl extended-release tablets orally once daily in the morning with food. Swallow dapagliflozin and metformin HCl extended-release tablets whole and never crush, cut, or chew.

2.3 Recommended

Dosage Individualize the starting dosage of dapagliflozin and metformin HCl extended-release tablets based upon the patient’s current regimen. Patients taking an evening dosage of metformin HCl extended-release should skip their last dose before starting dapagliflozin and metformin HCl extended-release tablets. To improve glycemic control in adult patients not already taking: Dapagliflozin: the recommended starting dosage of dapagliflozin in dapagliflozin and metformin HCl extended-release tablets is 5 mg orally once daily.

Metformin HCl extended-release: the recommended starting dosage of metformin HCl extended-release in dapagliflozin and metformin HCl extended-release tablets is 500 mg orally once daily. For dapagliflozin and metformin HCl extended-release tablets indications in adults related to heart failure and chronic kidney disease, the recommended dosage of dapagliflozin in dapagliflozin and metformin HCl extended-release tablets is 10 mg orally once daily. For all dapagliflozin and metformin HCl extended-release tablets 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. Pediatric use information is approved for AstraZeneca AB’s Xigduo ® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.

2.4 Recommended

Dosage in Patients with Renal Impairment The recommended dosage of dapagliflozin and metformin HCl extended-release tablets in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. Initiation of dapagliflozin and metformin HCl extended-release tablets are not recommended in patients with an eGFR between 30 and 45 mL/min/1.73 m 2. Assess the benefit and risk of continuing therapy if eGFR falls persistently below this level. Dapagliflozin is likely to be ineffective to improve glycemic control in patients with eGFR less than 45 mL/min/1.73 m 2. Metformin HCl initiation is not recommended for patients with eGFR less than 45 mL/min/1.73 m 2. Dapagliflozin and metformin HCl extended-release tablets are contraindicated in patients with an eGFR below 30 mL/min/1.73 m 2 and end-stage renal disease due to the metformin HCl component.

2.5 Discontinuation for

Iodinated Contrast Imaging Procedures Discontinue dapagliflozin and metformin HCl extended-release tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 60 mL/min/1.73 m 2, 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 dapagliflozin and metformin HCl extended-release tablets if renal function is stable.

2.6 Temporary

Interruption for Surgery Withhold dapagliflozin and metformin HCl extended-release tablets for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume dapagliflozin and metformin HCl extended-release tablets when the patient is clinically stable and has resumed oral intake.