Product Information:

DAPLYZA 5mg + 1000mg Tablets is a fixed-dose combination of Dapagliflozin 5mg and Metformin Hydrochloride 1000mg, 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 reduces hepatic glucose production and improves insulin sensitivity. This formulation combines a lower dose of dapagliflozin with a full dose of immediate-release metformin, offering dual-pathway glucose control.

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

1. Treatment of type 2 diabetes in adults inadequately controlled on monotherapy with metformin or dapagliflozin
2. Initial combination therapy in patients with high baseline HbA1c
3. Patients requiring simplified dual therapy in a single tablet
4. Cardiovascular risk reduction in diabetic patients with established heart disease (dapagliflozin benefit)

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

1. Dual mechanism: targets both liver (metformin) and kidney (dapagliflozin)
2. Once-daily dosing improves adherence
3. Lower dapagliflozin dose may enhance tolerability in sensitive patients
4. Promotes modest weight loss and reduces systolic blood pressure
5. Dapagliflozin provides cardio-renal protective effects

How To Use (DAPLYZA 5mg+1000mg TABLETS):

Take one tablet once daily with the evening meal to reduce gastrointestinal side effects from metformin. Swallow whole with water—do not crush or chew. 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 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 5mg+1000mg TABLETS):

Common: Genital mycotic infections, urinary tract infections, increased urination, nausea, diarrhea, abdominal discomfort (due to 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 5mg+1000mg TABLETS):

1. Standard adult dose: One tablet once daily with evening meal
2. May be escalated to higher strengths (e.g., 10mg dapagliflozin + 1000mg metformin) based on response
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 5mg+1000mg TABLETS):

Adults with type 2 diabetes requiring dual oral therapy, especially those already on metformin 1000mg who need cautious addition of an SGLT2 inhibitor. 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 stop 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: Raises lactic acidosis risk
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 printed on the blister pack. Available by prescription in Pakistan.