Xigduo XR

Xigduo XR

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 5 mg/1,000 mg MR-FC tab Dapagliflozin propanediol monohydrate 5 mg, metformin HCl extended-release 1,000 mg. Per 10 mg/500 mg MR-FC tab Dapagliflozin propanediol monohydrate 10 mg, metformin HCl extended-release 500 mg. Per 10 mg/1,000 mg MR-FC tab Dapagliflozin propanediol monohydrate 10 mg, metformin HCl extended-release 1,000 mg
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM. Reduce risk of hospitalization for heart failure in adults w/ type 2 DM & established CV disease or multiple CV risk factors.
Dosage/Direction for Use
Individualized dosage. Recommended initial dose: Dapagliflozin 10 mg & metformin HCl extended-release 500 mg once daily, may be titrated to 2,000 mg once daily. Max daily dose: Dapagliflozin 10 mg & metformin HCl extended-release 2,000 mg.
Administration
Should be taken with food: Take w/ evening meal. Swallow whole, do not chew/crush/cut tab.
Contraindications
Hypersensitivity. Lactic acidosis, diabetic ketoacidosis; acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock or intravascular administration of iodinated contrast agents; acute or chronic disease causing tissue hypoxia eg, cardiac or resp failure, pulmonary embolism, recent MI, acute significant blood loss, sepsis, gangrene, pancreatitis; during or immediately following surgery where insulin is essential, elective major surgery; acute alcohol intoxication, alcoholism. Hepatic impairment. Severe renal impairment (eGFR <30 mL/min). Lactation.
Special Precautions
Not to be used in patients w/ type 1 DM or diabetic ketoacidosis. Lactic acidosis; inadequately controlled diabetes, ketosis, prolonged fasting, any conditions associated w/ hypoxia; CV collapse (shock), acute CHF & MI, other conditions associated w/ hypoxemia; acute conditions eg, dehydration, severe infections, hypoperfusion; risk of vol depletion, hypotension &/or electrolyte imbalance; GI illness, heat stress, severe infections; known CV disease; history of hypotension; urosepsis, pyelonephritis; necrotising perineum fasciitis/Fournier's gangrene; patients w/ low β-cell function reserve; insulin dose reduction; reduced caloric intake; increased insulin requirements due to infection, illness or surgery; loss of blood glucose control; cardiac failure (NYHA I-IV). Discontinue use prior to or during iodinated contrast agent administration & not to be reinstituted until 48 hr afterwards. Discontinue use 48 hr before elective surgery w/ general, spinal or epidural anaesth. Assess & monitor renal function prior to & at least annually thereafter. Regularly evaluate serum electrolytes & ketones, blood glucose, pH, lactate, pyruvate & metformin levels. Hypoglycemia w/ insulin & insulin secretagogues eg, sulfonylureas. Concomitant use w/ antihypertensive, diuretics, NSAIDs; drugs causing lactic acidosis. Interference w/ 1,5-anhydroglucitol assay. Acute or chronic excessive alcohol intake. Counsel patients on routine preventive foot care. May affect ability to drive & use machines. Not to be used in moderate & severe renal impairment or end-stage renal disease. Not to be used in severe hepatic impairment; clinical or laboratory evidence of hepatic disease. Not to be used during 2nd & 3rd trimesters of pregnancy & lactation. Ped & adolescent patients. Elderly.
Adverse Reactions
Dapagliflozin: Renal impairment, decreased CrCl, increased blood creatinine; UTI, vulvovag mycotic infection; back pain; polyuria; hypoglycemia; headache. Metformin: Mild GI symptoms eg, diarrhoea, nausea, vomiting, abdominal pain, loss of appetite. Taste disturbance.
Drug Interactions
Dapagliflozin: Decreased exposure w/ rifampicin. Increased exposure w/ mefenamic acid. Metformin: Potential interaction in renal tubular secretion w/ cationic drugs eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin. Increased Cmax & AUC w/ frusemide, nifedipine. Hyperglycemia w/ thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers, 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/1,000 mg MR-FC tab
Packing/Price
28's
Form
Xigduo XR 10 mg/500 mg MR-FC tab
Packing/Price
28's
Form
Xigduo XR 5 mg/1,000 mg MR-FC tab
Packing/Price
56's
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