Xigduo XR

Xigduo XR

Manufacturer:

AstraZeneca
Concise Prescribing Info
Contents
Per 5 mg/1,000 mg XR-FC tab dapagliflozin 5 mg, metformin HCl extended-release 1,000 mg. Per 10 mg/500 mg XR-FC tab dapagliflozin 10 mg, metformin HCl extended-release 500 mg. Per 10 mg/1,000 mg XR-FC tab dapagliflozin 10 mg, metformin HCl extended-release 1,000 mg
Indications/Uses
Substitution therapy for treatment of type II DM in adjunct to diet & exercise to improve glycemic control in adult patients already controlled w/ dapagliflozin & metformin XR given concurrently at the same dose level.
Dosage/Direction for Use
Once daily dosing. Max daily dose: Dapagliflozin 10 mg & metformin HCl 2,000 mg.
Administration
Should be taken with food: Take w/ evening meal. Swallow whole, do not crush/cut/chew.
Contraindications
History of any serious hypersensitivity reaction. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Treat diabetic ketoacidosis w/ insulin. Diabetic pre-coma. Acute conditions w/ the potential to alter renal function eg, dehydration, severe infection, shock. Acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock, acute alcohol intoxication, alcoholism. Severe renal impairment (eGFR <30 mL/min/1.73 m2), ESRD or patients on dialysis. Hepatic impairment.
Special Precautions
Hypersensitivity to dapagliflozin or metformin. Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Not for patients w/ type 1 DM, diabetic ketoacidosis. Moderate to severe kidney problems. Lactic acidosis. Excessive alcohol intake. Low level of vit B12. Surgical procedure. Patients who use cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin). Hypoxic states. Loss of control of blood glucose: fever, trauma, infection, or surgery, a temporary loss of glycemic control. Patients receiving loop diuretics or who are vol depleted. Concomitant use of medications known to cause hypoglycemia (insulin, insulin secretagogues, eg, sulfonylurea). Patients w/ UTI (urosepsis & pyelonephritis). Diabetic patients on routine preventative foot care. Pregnancy & lactation. Elderly.
Adverse Reactions
Dehydration, ketoacidosis, low blood sugar (hypoglycemia), kidney problems, vit B12 deficiency, vag yeast infection, balanitis, increased blood cholesterol, bladder cancer, diarrhea, headache, nausea & vomiting, stuffy or runny nose, genital infection, ketoacidosis, UTI.
Drug Interactions
May produce hyperglycemia & may lead to loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin or phenobarb, nicotinic acid, sympathomimetics, Ca channel blocking drugs, INH, rifampin, ritonavir & digoxin.
MIMS Class
Antidiabetic Agents
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 5 mg/1,000 mg XR-FC tab
Packing/Price
4 × 7's
Form
Xigduo XR 10 mg/500 mg XR-FC tab
Packing/Price
4 × 7's
Form
Xigduo XR 10 mg/1,000 mg XR-FC tab
Packing/Price
4 × 7's (Rp823,373/boks)
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