Xigduo XR

Xigduo XR

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Per 5/500 mg FC tab dapagliflozin propanediol monohydrate 5 mg, metformin HCl 500 mg. Per 5 mg/1,000 mg FC tab dapagliflozin propanediol monohydrate 5 mg, metformin HCl 1,000 mg. Per 10 mg/500 mg FC tab dapagliflozin propanediol monohydrate 10 mg, metformin HCl 500 mg. Per 10 mg/1,000 mg FC tab dapagliflozin propanediol monohydrate 10 mg, metformin HCl 1,000 mg
Indications/Uses
Adjunct to diet & exercise in treatment of type 2 DM. Prevention of new or worsening heart failure or CV death, nephropathy.
Dosage/Direction for Use
Dapagliflozin 10 mg once daily. Starting dose: Metformin 500 mg once daily, which can be titrated to 2,000 mg once daily w/ gradual dose escalation.
Administration
Should be taken with food: Take w/ evening meal. Swallow whole, do not crush/cut/chew.
Contraindications
Hypersensitivity. Severe renal impairment (eGFR <30 mL/min/1.73 m2), metabolic acidosis.
Special Precautions
Do not use in patients w/ type 1 DM or for diabetic ketoacidosis. Lactic acidosis epecially in diabetic patients w/ significant renal failure; risk factors eg, poorly controllled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency, dehydration, acute conditions associated w/ hypoxia or impacting renal function. Concomitant w/ drugs that can acutely impair renal function eg, antihypertensives, diuretics & NSAIDs. Discontinue if metabolic acidosis is suspected. Discontinue when dehydration, severe infection & hypoperfusion occurs. Promptly discontinue if CV collapse (shock, acute CHF, acute MI, or other conditions characterized by hypoxemia occurs. Temporarily discontinue therapy at the time of or prior to intravascular contrast studies w/ iodinated materials, & w/held for 48 hr & reinstituted only after renal function has been re-evaluated. Temporarily suspend for any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids). Excessive alcohol intake. Predisposing factors to ketoacidosis eg, low β-cell function reserve resulting from pancreatic disorders (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery & alcohol abuse. Evaluate serum electrolytes & ketones, blood glucose, blood pH, lactate pyruvate, & metformin levels in patients w/ type 2 DM. Temporary interruption for patients who develop vol depletion. Concomitant use w/ insulin & insulin secretagogues eg, sulfonylureas. Hypoglycemia especially in elderly, debilitated, or malnourished patients & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Discontinue if Fournier's gangrene is suspected. eGFR persistently <45 mL/min/1.73 m2, severe renal impairment (eGFR <30 mL/min/1.73 m2 by MDRD) or end-stage renal disease. Assess renal function before initiation of therapy. Avoid in patients w/ clinical or laboratory evidence of hepatic disease. Do not use during pregnancy (2nd & 3rd trimesters) & lactation. Childn. Elderly.
Adverse Reactions
Dapagliflozin: Genital infection, UTI; back pain, pollakiuria & polyuria. Diabetic ketoacidosis. Metformin: GI symptoms. Taste disturbance.
Drug Interactions
Increased peak metformin plasma, whole blood conc, plasma & whole blood metformin w/ cationic drugs (eg, amiloride, digoxin, morphine procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin). Decreases AUC & Cmax of glyburide. Increased metformin plasma & blood Cmax & AUC w/ furosemide. Increased plasma metformin Cmax & AUC w/ nifedipine. Hyperglycemia w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs & INH.
MIMS Class
ATC Classification
A10BD15 - metformin and dapagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Xigduo XR 10 mg/1000 mg FC tab
Packing/Price
28's
Form
Xigduo XR 10 mg/500 mg FC tab
Packing/Price
28's
Form
Xigduo XR 5 mg/1000 mg FC tab
Packing/Price
28's
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