Product Information:

DAPLYZA 5mg + 850mg Tablets is a fixed-dose combination of Dapagliflozin 5mg and Metformin Hydrochloride 850mg, 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, promotes urinary glucose excretion. Metformin reduces hepatic glucose production and enhances insulin sensitivity. This formulation offers a balanced dual-therapy option for patients transitioning from metformin monotherapy or requiring moderate-intensity combination treatment.

Uses of (DAPLYZA 5mg+850mg TABLETS):

1. Treatment of type 2 diabetes in adults inadequately controlled on metformin or dapagliflozin alone
2. Initial combination therapy in patients with moderate hyperglycemia
3. Simplified dual therapy in a single tablet to improve adherence
4. Cardiovascular risk reduction in diabetic patients with established heart disease (dapagliflozin benefit)

Key Benefits of (DAPLYZA 5mg+850mg TABLETS):

1. Dual mechanism targeting liver and kidney glucose pathways
2. Once-daily dosing with evening meal for better GI tolerance
3. Lower dapagliflozin dose may suit patients with volume sensitivity or borderline renal function
4. Promotes modest weight loss and lowers systolic blood pressure
5. Dapagliflozin provides cardio-renal protective effects

How To Use (DAPLYZA 5mg+850mg TABLETS):

Take one tablet once daily with the evening meal to minimize gastrointestinal side effects. Swallow whole with water—do not crush or chew. 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 5mg+850mg 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+850mg TABLETS):

Common: Genital yeast infections, urinary tract infections, increased urination, nausea, diarrhea, abdominal discomfort (due to 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+850mg 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 glycemic 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+850mg TABLETS):

Adults with type 2 diabetes requiring dual oral therapy, especially those previously on metformin 850mg who need cautious addition of an SGLT2 inhibitor. Ideal for elderly or volume-sensitive patients. 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 mycotic infections and 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.