Product Information:

DAPLYZA M XR 5mg + 1000mg Tablets is a fixed-dose combination of Dapagliflozin 5mg and Metformin Hydrochloride Extended-Release (XR) 1000mg, used as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, reduces blood glucose by promoting urinary excretion of glucose. Metformin XR decreases hepatic glucose production and improves insulin sensitivity. This formulation provides a lower dose of dapagliflozin with a full-strength metformin XR component, suitable for patients requiring metformin optimization with cautious SGLT2 inhibition.

Uses of (DAPLYZA M XR 5mg+1000mg TABLETS):

1. Treatment of type 2 diabetes in adults inadequately controlled on metformin monotherapy
2. Patients needing SGLT2 inhibitor initiation at a lower dose due to tolerability or renal considerations
3. Dual therapy in patients with moderate hyperglycemia and preserved kidney function
4. Cardiovascular risk mitigation in diabetic patients with established heart disease (dapagliflozin benefit)

Key Benefits of (DAPLYZA M XR 5mg+1000mg TABLETS):

1. Combines full-dose metformin XR with a lower, well-tolerated dose of dapagliflozin
2. Once-daily dosing with evening meal for improved adherence
3. Metformin XR minimizes gastrointestinal side effects (e.g., diarrhea, nausea)
4. Promotes modest weight loss and reduces systolic blood pressure
5. Dapagliflozin offers cardio-renal protective effects even at 5mg

How To Use (DAPLYZA M XR 5mg+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. Not indicated for type 1 diabetes or diabetic ketoacidosis.

When Not to Use (DAPLYZA M XR 5mg+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 Fournier’s gangrene or serious hypersensitivity to SGLT2 inhibitors
5. Hepatic impairment or acute alcohol intoxication

Side Effects of (DAPLYZA M XR 5mg+1000mg TABLETS):

Common: Genital mycotic infections (e.g., vulvovaginal candidiasis), urinary tract infections, increased urination, mild GI upset (less with XR).

Serious (rare):

1. Lactic acidosis (metformin-related—symptoms: muscle pain, weakness, rapid breathing, 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 euglycemic ketoacidosis
4. Discontinue and seek immediate medical attention if these occur.

Dosage: (DAPLYZA M XR 5mg+1000mg TABLETS):

1. Standard adult dose: One tablet once daily with evening meal
2. May be escalated to DAPLYZA M XR 10mg+1000mg based on glycemic response and tolerability
3. Renal function must be assessed before initiation and monitored periodically
4. Avoid if eGFR <45 mL/min; discontinue if eGFR falls persistently below 30 mL/min

Who It’s For (DAPLYZA M XR 5mg+1000mg TABLETS):

Adults with type 2 diabetes already stabilized on metformin 1000mg XR who require cautious addition of an SGLT2 inhibitor. Ideal for elderly patients, those with borderline renal function, or those prone to volume depletion. Not for type 1 diabetes, children, or severe organ dysfunction.

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. Ensure adequate hydration to prevent hypotension
5. May cause false-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 and supplements.

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 printed on the blister pack. Available by prescription in Pakistan.