Product Information:

DAPLYZA M XR 10mg + 1000mg Tablets is a fixed-dose combination of Dapagliflozin 10mg and Metformin Hydrochloride Extended-Release (XR) 1000mg, used for the management of type 2 diabetes mellitus. Dapagliflozin, an SGLT2 inhibitor, promotes urinary glucose excretion by blocking glucose reabsorption in the kidneys. Metformin XR reduces hepatic glucose production and improves insulin sensitivity. The extended-release formulation of metformin minimizes gastrointestinal side effects while providing once-daily dosing convenience.

Uses of (DAPLYZA M XR 10mg+1000mg TABLETS):

1. Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
2. Patients inadequately controlled on metformin monotherapy or dapagliflozin alone
3. First-line combination therapy in patients with high HbA1c at diagnosis
4. Cardiovascular risk reduction in diabetic patients with established heart disease (dapagliflozin component)

Key Benefits of (DAPLYZA M XR 10mg+1000mg TABLETS):

1. Dual mechanism: reduces both hepatic glucose output and renal glucose reabsorption
2. Once-daily dosing improves adherence
3. Metformin XR formulation reduces GI side effects (e.g., diarrhea, nausea)
4. Promotes modest weight loss and lowers blood pressure
5. Dapagliflozin offers cardio-renal protection in high-risk patients

How To Use (DAPLYZA M XR 10mg+1000mg TABLETS):

Take one tablet once daily with the evening meal to reduce gastrointestinal discomfort. Swallow whole—do not crush, chew, or split. Continue diet and exercise regimen. Monitor blood glucose and HbA1c regularly. Do not use in patients with type 1 diabetes or diabetic ketoacidosis.

When Not to Use (DAPLYZA M XR 10mg+1000mg TABLETS):

Do not use if you have:

1. Hypersensitivity to dapagliflozin, metformin, or any excipients
2. Severe renal impairment (eGFR <30 mL/min) or end-stage renal disease
3. Acute or chronic metabolic acidosis (including diabetic ketoacidosis)
4. History of serious hypersensitivity reaction to dapagliflozin (e.g., Fournier’s gangrene)
5. Hepatic impairment or acute alcohol intoxication

Side Effects of (DAPLYZA M XR 10mg+1000mg TABLETS):

Common: Genital mycotic infections (e.g., yeast infection), urinary tract infections, nausea, diarrhea (less with XR), increased urination.

Serious (rare):

1. Lactic acidosis (metformin-related—symptoms: muscle pain, weakness, breathing difficulty, drowsiness)
2. Fournier’s gangrene (necrotizing fasciitis of perineum—seek emergency care for pain/redness/swelling in genital area)
3. Hypotension, acute kidney injury, or ketoacidosis (even with normal blood glucose)
4. Discontinue and seek immediate medical help if these occur.

Dosage: (DAPLYZA M XR 10mg+1000mg TABLETS):

1. Standard adult dose: One tablet once daily with evening meal
2. Renal function must be assessed before initiation and periodically thereafter
3. Not recommended if eGFR <45 mL/min; discontinue if eGFR falls persistently below 30 mL/min

Who It’s For (DAPLYZA M XR 10mg+1000mg TABLETS):

Adults with type 2 diabetes requiring dual oral therapy. Ideal for those already on metformin needing intensification, or newly diagnosed patients with high HbA1c. Not for type 1 diabetes, children, or patients with severe kidney/liver disease.

Warnings & Precautions:

1. Risk of lactic acidosis—avoid in hypoxia, dehydration, or excessive alcohol use
2. Monitor for signs of genital infections or UTIs
3. Temporarily discontinue before iodinated contrast imaging or major surgery
4. Volume depletion may cause hypotension—ensure adequate hydration
5. May cause positive urine glucose tests (due to glucosuria)

Drug Interactions:

1. Diuretics, ACE inhibitors: May enhance hypotensive effect
2. Insulin or sulfonylureas: Increased risk of hypoglycemia
3. Alcohol: Increases risk of lactic acidosis
4. Cimetidine: May increase metformin levels
5. Always inform your doctor about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date on the blister pack. Available by prescription in Pakistan.