Product Information:

DAPLYZA M XR 5mg + 500mg Tablets is a fixed-dose combination of Dapagliflozin 5mg and Metformin Hydrochloride Extended-Release (XR) 500mg, used as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, an SGLT2 inhibitor, lowers blood glucose by promoting urinary excretion of glucose. Metformin XR reduces hepatic glucose production and improves insulin sensitivity. The extended-release formulation minimizes gastrointestinal side effects, while the lower doses of both components make this ideal for therapy initiation or dose titration.

Uses of (DAPLYZA M XR 5mg+500mg TABLETS):

1. Initial combination therapy in treatment-naïve adults with type 2 diabetes and elevated HbA1c
2. Step-up therapy for patients inadequately controlled on lifestyle measures alone
3. Patients requiring gentle dual therapy due to age, GI sensitivity, or comorbidities
4. Cardiovascular risk reduction in diabetic patients with established heart disease (dapagliflozin benefit)

Key Benefits of (DAPLYZA M XR 5mg+500mg TABLETS):

1. Dual mechanism targeting liver and kidney glucose pathways
2. Once-daily dosing with evening meal for improved adherence
3. Metformin XR formulation significantly reduces nausea, diarrhea, and abdominal discomfort
4. Lower starting doses enhance tolerability and allow safe dose escalation
5. Promotes modest weight loss and lowers systolic blood pressure
6. Dapagliflozin provides cardio-renal protective effects

How To Use (DAPLYZA M XR 5mg+500mg TABLETS):

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

When Not to Use (DAPLYZA M XR 5mg+500mg 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+500mg TABLETS):

Common: Genital mycotic infections (e.g., yeast infection), urinary tract infections, increased urination, mild GI upset (less frequent than immediate-release metformin).

Serious (rare):

1. Lactic acidosis (symptoms: muscle pain, weakness, rapid breathing, drowsiness)—seek emergency care
2. Fournier’s gangrene (severe pain/redness/swelling in genital/perineal area)—discontinue immediately
3. Hypotension, acute kidney injury, or euglycemic ketoacidosis
4. Discontinue and seek medical help if these occur.

Dosage: (DAPLYZA M XR 5mg+500mg TABLETS):

1. Standard adult dose: One tablet once daily with evening meal
2. May be escalated to higher strengths (e.g., 5/1000mg, 10/1000mg) 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 persistently <30 mL/min

Who It’s For (DAPLYZA M XR 5mg+500mg TABLETS):

Adults with newly diagnosed or mild type 2 diabetes initiating dual oral therapy. Ideal for elderly patients, those with gastrointestinal sensitivity, or those requiring cautious dose escalation. Not for type 1 diabetes, children, or severe organ dysfunction.

Warnings & Precautions:

1. Risk of lactic acidosis—avoid in dehydration, hypoxia, or excessive alcohol use
2. Monitor for genital infections and UTIs
3. Temporarily discontinue before iodinated contrast imaging or major surgery
4. Ensure adequate hydration to prevent volume depletion
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.