Product Information:

DAPLYZA 5mg Tablets contain Dapagliflozin as the active ingredient, a selective sodium-glucose cotransporter-2 (SGLT2) inhibitor. It works by blocking glucose reabsorption in the proximal renal tubules of the kidneys, leading to increased urinary excretion of glucose and a subsequent reduction in blood glucose levels—independent of insulin. This lower-strength formulation is suitable for treatment initiation, dose titration, or use in patients requiring cautious SGLT2 inhibition due to age, renal function, or concomitant medications.

Uses of (DAPLYZA 5mg TABLETS):

1. Monotherapy or add-on therapy for glycemic control in adults with type 2 diabetes mellitus
2. Patients with borderline renal function or at risk of volume depletion
3. Cardiovascular risk reduction in type 2 diabetes with established heart disease or multiple risk factors
4. Slowing progression of chronic kidney disease in diabetic patients (eGFR ≥25 mL/min)
5. Adjunctive treatment in heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status (per updated clinical guidelines)

Key Benefits of (DAPLYZA 5mg TABLETS):

1. Lower starting dose for improved tolerability
2. Insulin-independent mechanism—minimal risk of hypoglycemia when used alone
3. Promotes modest weight loss and reduces systolic blood pressure
4. Offers cardio-renal protection: lowers risk of heart failure hospitalization and slows kidney decline
5. Once-daily oral dosing for long-term management

How To Use (DAPLYZA 5mg TABLETS):

Take one tablet once daily in the morning, with or without food. Swallow whole with water—do not crush or chew. Continue diet and exercise regimen. Monitor blood glucose, HbA1c, renal function, and blood pressure regularly. Not for use in type 1 diabetes or diabetic ketoacidosis.

When Not to Use (DAPLYZA 5mg TABLETS):

Do not use if you have:

1. Hypersensitivity to dapagliflozin or any excipients
2. Severe renal impairment (eGFR <30 mL/min) or end-stage renal disease
3. Active volume depletion (e.g., from diuretics, vomiting, or diarrhea)
4. History of Fournier’s gangrene or serious hypersensitivity reaction
5. Type 1 diabetes or diabetic ketoacidosis

Side Effects of (DAPLYZA 5mg TABLETS):

Common: Genital mycotic infections (e.g., yeast infection), urinary tract infections, increased urination, mild dizziness.

Serious (rare):

1. Fournier’s gangrene (necrotizing fasciitis of perineum—seek emergency care for pain/redness/swelling in genital area)
2. Hypotension, acute kidney injury, or euglycemic diabetic ketoacidosis (symptoms: nausea, vomiting, abdominal pain, fatigue—even with normal blood sugar)
3. Dehydration, especially in elderly or those on diuretics
4. Discontinue and seek immediate medical help if these occur.

Dosage: (DAPLYZA 5mg TABLETS):

1. Standard adult dose: 5mg once daily
2. May be increased to 10mg once daily based on glycemic response and tolerability
3. Avoid initiation if eGFR <45 mL/min; discontinue if eGFR persistently <30 mL/min

Who It’s For (DAPLYZA 5mg TABLETS):

Adults with type 2 diabetes initiating SGLT2 inhibitor therapy, elderly patients, those with mild-moderate renal impairment, or individuals at risk of volume depletion. Also used in heart failure (HFrEF) per current guidelines. Not for children, type 1 diabetes, or severe kidney disease.

Warnings & Precautions:

1. Correct volume depletion before starting therapy
2. Monitor for signs of genital infections or UTIs
3. Temporarily discontinue before surgery or iodinated contrast procedures
4. Educate patients on symptoms of ketoacidosis
5. May cause false-positive urine glucose tests due to glucosuria

Drug Interactions:

1. Diuretics, ACE inhibitors, ARBs: Increased risk of hypotension or renal dysfunction
2. Insulin or sulfonylureas: Low hypoglycemia risk, but possible
3. No significant CYP450 interactions
4. 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.