Product Information:

DAPLYZA 10mg 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, leading to increased urinary glucose excretion and lowering of blood glucose levels independent of insulin. DAPLYZA is used as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes mellitus and offers additional cardio-renal protective benefits.

Uses of (DAPLYZA 10mg TABLETS):

1. Monotherapy or add-on therapy for type 2 diabetes mellitus in adults
2. Reduction of risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple risk factors
3. Slowing progression of kidney disease in patients with diabetic nephropathy (eGFR ≥25 mL/min)
4. Adjunctive treatment in heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status (off-label or per updated guidelines)

Key Benefits of (DAPLYZA 10mg TABLETS):

1. Insulin-independent mechanism of action—low risk of hypoglycemia when used alone
2. Promotes modest weight loss and reduces systolic blood pressure
3. Proven cardio-renal protection: lowers risk of heart failure hospitalization and slows kidney function decline
4. Once-daily oral dosing for convenient long-term management
5. Can be combined with metformin, sulfonylureas, insulin, or other antidiabetics

How To Use (DAPLYZA 10mg 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 10mg 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., due to diuretics, vomiting, diarrhea)
4. History of serious hypersensitivity reaction or Fournier’s gangrene
5. Type 1 diabetes or diabetic ketoacidosis

Side Effects of (DAPLYZA 10mg TABLETS):

Common: Genital mycotic infections (e.g., vulvovaginal candidiasis, balanitis), 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 (even with normal blood glucose)
3. Dehydration or volume depletion, especially in elderly or on diuretics
4. Discontinue and seek immediate medical help if these occur.

Dosage: (DAPLYZA 10mg TABLETS):

1. Standard adult dose: 10mg once daily
2. No dose adjustment needed for mild hepatic impairment
3. Avoid initiation if eGFR <45 mL/min; discontinue if eGFR persistently <30 mL/min

Who It’s For (DAPLYZA 10mg TABLETS):

Adults with type 2 diabetes requiring glucose-lowering therapy, especially those with cardiovascular disease, heart failure, or chronic kidney disease. Also used off-label in non-diabetic HFrEF per recent guidelines. Not for children, type 1 diabetes, or severe renal impairment.

Warnings & Precautions:

1. Assess volume status before starting—correct dehydration first
2. Monitor for signs of genital infections or UTIs
3. Temporarily discontinue before surgery or iodinated contrast procedures
4. Counsel patients on symptoms of ketoacidosis (nausea, vomiting, abdominal pain, fatigue)
5. May cause positive urine glucose tests due to glucosuria

Drug Interactions:

1. Diuretics, ACE inhibitors, ARBs: Increased risk of hypotension or renal impairment
2. Insulin or sulfonylureas: Lowers risk of hypoglycemia vs. other combos, but still 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.