Product Information:

ERTUGET 5mg Tablets contain Ertugliflozin as the active ingredient, a selective sodium-glucose cotransporter-2 (SGLT2) inhibitor. It works by inhibiting 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. ERTUGET is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and offers additional benefits in cardiovascular and renal risk reduction.

Uses of (ERTUGET 5MG TABLETS):

1. Monotherapy or add-on therapy for type 2 diabetes mellitus in adults
2. Reduction of risk of major adverse cardiovascular events in patients with established cardiovascular disease
3. Slowing the progression of chronic kidney disease in patients with type 2 diabetes and albuminuria
4. Adjunctive treatment in heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status (per updated clinical guidelines)

Key Benefits of (ERTUGET 5MG TABLETS):

1. Insulin-independent mechanism—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, DPP-4 inhibitors, sulfonylureas, or insulin

How To Use (ERTUGET 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 indicated for type 1 diabetes or diabetic ketoacidosis.

When Not to Use (ERTUGET 5MG TABLETS):

Do not use if you have:

1. Hypersensitivity to ertugliflozin 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, or diarrhea)
4. History of Fournier’s gangrene or serious hypersensitivity reaction
5. Type 1 diabetes or diabetic ketoacidosis

Side Effects of (ERTUGET 5MG 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 (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: (ERTUGET 5MG TABLETS):

1. Standard adult dose: 5mg once daily
2. May be increased to 15mg 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 (ERTUGET 5MG TABLETS):

Adults with type 2 diabetes requiring glucose-lowering therapy, especially those with cardiovascular disease, heart failure, or chronic kidney disease. Also used in non-diabetic HFrEF per current 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
5. May cause false-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: Low hypoglycemia risk when combined, 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.