Xigduo XR Dosage
Generic name: DAPAGLIFLOZIN PROPANEDIOL 10mg, METFORMIN HYDROCHLORIDE 500mg
Dosage form: tablet, film coated, extended release
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- Healthcare providers should individualize the starting dose of XIGDUO XR based on the patient’s current treatment [see Dosage Forms and Strengths (3)].
- XIGDUO XR should be taken once daily in the morning with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin.
- 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 feces as a soft, hydrated mass that may resemble the original tablet.
- For patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily.
- For patients requiring a dose of 5 mg dapagliflozin and 2000 mg metformin HCl extended-release, use two of the 2.5 mg dapagliflozin/1000 mg metformin HCl extended-release tablets.
- Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 10 mg dapagliflozin and 2000 mg metformin HCl.
- Patients taking an evening dose of metformin XR should skip their last dose before starting XIGDUO XR.
- In patients with volume depletion, correcting this condition prior to initiation of XIGDUO XR is recommended [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Patient Counseling Information (17)].
Patients with Renal Impairment
Assess renal function before initiating XIGDUO XR therapy and periodically thereafter.
XIGDUO XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 [see Contraindications (4), Warnings and Precautions(5.1, 5.4), Adverse Reactions (6.1), and Use in Specific Populations (8.6)].
No dose adjustment for XIGDUO XR is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
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)].
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- Drug class: antidiabetic combinations