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XIGDUO XR
Diabetes
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Drug Name:

XIGDUO XR Rx

Generic Name and Formulations:
Dapagliflozin, metformin HCl ext-rel; 5mg/500mg, 5mg/1000mg, 10mg/500mg, 10mg/1000mg; tabs.

Company:
AstraZeneca Pharmaceuticals

Therapeutic Use:

Indications for XIGDUO XR:

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Limitations Of use:

Not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:

Individualize. Swallow whole. Take once daily in the AM with food; increase dose gradually. Maximum daily dose: 10mg/2000mg.

Children:

<18yrs: not established.

Contraindications:

Moderate-to-severe renal impairment (eGFR <60mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

Warnings/Precautions:

Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with a history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Monitor for symptomatic hypotension in renal impairment (eGFR <60mL/min/1.73m2), elderly, low systolic BP, or on loop diuretics. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Assess renal function prior to starting and periodically thereafter; more frequently in elderly. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, UTIs, hematology (esp. serum Vit. B12), increases in LDL-C; treat if needed. Active bladder cancer: do not use. Prior history of bladder cancer: consider glycemic control benefits vs. risk of cancer recurrence. Pregnancy (Cat.C; during 2nd & 3rd trimesters), nursing mothers: not recommended.

Interactions:

Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels; monitor. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, CCBs, and isoniazid may cause hyperglycemia. Avoid excessive alcohol. Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Pharmacological Class:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor + biguanide.

Adverse Reactions:

Female genital mycotic infections, nasopharyngitis, UTIs (may be serious), diarrhea, headache, nausea, vomiting; ketoacidosis, acute kidney injury, urosepsis, pyelonephritis, hepatocellular liver injury; rare: lactic acidosis.

Generic Availability:

NO

How Supplied:

XR tabs 5mg/ 500mg, 10mg/500mg—30, 500; 5mg/1000mg—30, 60, 90, 400; 10mg/1000mg—30, 90, 400

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