REMINDER: A doctor’s prescription is required to purchase this product. To avoid delay in delivery or cancellation of your order (before the item is SHIPPED); please email a copy of your prescription (.jpeg or .pdf file format) to OnlinePharmacy@smwatsons.com with your order number after Checkout. Our pharmacist will also get in touch with you to validate your prescription. Please be ready to show your original prescription upon claiming/delivery of your order.
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when treatment w/ both dapagliflozin & metformin is appropriate.
Place of Origin
Individualized dosage. Max: Dapagliflozin 10 mg & metformin HCl 2,000 mg. If therapy w/ a combination of dapagliflozin & metformin is appropriate: 10 mg/500 mg once daily. Max: 10 mg/2,000 mg daily taken as two 5 mg/1,000 mg tab. In patients who need 10 mg dapagliflozin & not currently treated w/ metformin 10 mg/500 mg once daily w/ gradual dose escalation. In patients treated w/ metformin, the dose of Xigduo XR should provide metformin at the dose already being taken or to the nearest therapeutically appropriate dose. In patients who need 5 mg of dapagliflozin & not currently treated w/ metformin: 5 mg/500 mg once daily w/ gradual dose escalation. In patients who need 5 mg dapagliflozin in combination w/ metformin extended-release: 5 mg/1,000 mg. Patients who need 5 mg dapagliflozin who require a dose of metformin >1,000 mg: Use the individual components. Generally administered once daily w/ evening meal.
Contraindications: Hypersensitivity. Renal disease or impairment [eg, serum creatinine levels ≥1.5 mg/dL (males), ≥1.4 mg/dL (females) or abnormal CrCl]. Acute or chronic metabolic acidosis, including diabetic ketoacidosis w/ or w/o coma. Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.
Special Precautions: Increased risk of UTI. Not to be used in pregnancy (2nd & 3rd trimester) & lactation. Childn & adolescent; caution in elderly. Lactic acidosis. Moderate to severe renal impairment. Not recommended for the treatment of diabetes in patients w/ eGFR persistently <45 mL/min/1.73 m2. Not to be used in severe renal impairment (eGFR <30 mL/min/1.73 m2 by MDRD CrCl ≤30 mL/min by Cockcroft-Gault) or end-stage renal disease; discontinue if evidence of renal impairment is present. Avoid in patients w/ clinical or lab evidence of hepatic disease. Acute or chronic excessive alcohol intake. Not for the treatment of type 1 DM. Discontinue or temporary interruption if ketoacidosis is suspected. Routine serum vit B12 measurements at 2-3 yr intervals. Temporarily suspend treatment in any surgical procedure (except minor procedure not associated w/ restricted intake of food & fluids). Caution combination w/ cationic drugs. Discontinue treatment at the time of or prior to the procedure (intravascular contrast studies w/ iodinated materials) & w/held for 48 hr subsequent to the procedure. CV collapse (shock), acute CHF & MI. Risk of hypoglycemia & loss of glycemic control. Risk for vol depletion.
Each film-coated tablet contains 10 mg dapagliflozin (as dapagliflozin propanediol monohydrate) and 500 mg metformin hydrochloride in extended-release form.
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