DAPAGLOZNAL 10 MG ( DAPAGLIFLOZIN ) 28 FILM-COATED TABLETS

DAPAGLOZNAL 10 MG FILM-COATED TABLETS

Active Ingredient: Dapagliflozin 10 mg
Drug Class: Sodium–glucose cotransporter-2 (SGLT2) inhibitor
Dosage Form: Film-coated tablets
Pack Size: 28 tablets

Medical Description

Dapagloznal 10 mg contains dapagliflozin, an oral SGLT2 inhibitor used in the management of type 2 diabetes mellitus and, depending on the approved indication and patient characteristics, in the treatment of heart failure and chronic kidney disease.

Dapagliflozin works independently of insulin by reducing the reabsorption of filtered glucose in the kidneys. This increases urinary glucose excretion and lowers blood glucose. Beyond its glucose-lowering action, dapagliflozin has demonstrated important cardiovascular and kidney benefits in appropriate patient populations. Current ADA Standards of Care recommend SGLT2 inhibitors with demonstrated benefit for appropriate patients with type 2 diabetes, chronic kidney disease, cardiovascular disease, or heart failure.

How Dapagliflozin Works

Dapagliflozin selectively inhibits SGLT2, a transporter responsible for most renal glucose reabsorption in the proximal tubule.

Blocking SGLT2:

• Reduces renal glucose reabsorption.
• Increases glucose excretion through the urine.
• Lowers plasma glucose and HbA1c.
• Produces a mild increase in urinary sodium and fluid excretion.
• May contribute to modest reductions in body weight and blood pressure.
• Provides cardiovascular and renal benefits that can occur partly independently of glucose lowering.

Therapeutic Uses

Dapagloznal 10 mg may be prescribed for adults in situations including:

1. Type 2 Diabetes Mellitus

Dapagliflozin can be used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. It may be used alone or together with other glucose-lowering medicines when clinically appropriate.

2. Heart Failure

Dapagliflozin 10 mg is used in appropriate adults with heart failure to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart-failure-related visits, according to the applicable approved indication.

Clinical evidence has demonstrated benefits across a range of heart-failure phenotypes, including heart failure with reduced and preserved ejection fraction.

3. Chronic Kidney Disease

Dapagliflozin may be used in appropriate adults with chronic kidney disease who are at risk of progression. It can reduce the risk of sustained decline in kidney function, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure.

The ADA 2026 Standards recommend SGLT2 inhibitor therapy with demonstrated kidney benefit for people with type 2 diabetes and CKD, including patients with eGFR ≥20 mL/min/1.73 m² when clinically appropriate.

Benefits of Dapagliflozin

When appropriately prescribed, dapagliflozin may provide:

• Improved blood glucose control in type 2 diabetes.
• Reduced risk of hospitalization for heart failure in appropriate patients.
• Cardiovascular benefits in selected patients.
• Slower progression of chronic kidney disease in appropriate populations.
• Modest reductions in body weight.
• Mild reduction in blood pressure related to its osmotic diuretic effect.

Important: These cardiovascular and kidney benefits are not limited to patients who need additional glucose lowering; SGLT2 inhibitors may be recommended for cardiovascular or renal protection in selected patients even when HbA1c is already at an individualized target.

Dosage & Administration

For the indications for which 10 mg is the recommended dose, dapagliflozin is generally taken as:

Adults: 10 mg orally once daily.

The tablet may generally be taken with or without food and should be taken at approximately the same time each day.

For glycemic control in type 2 diabetes, some approved labeling recommends an initial dose of 5 mg once daily, which may be increased to 10 mg for additional glycemic control. The 10 mg strength is the recommended dose for several heart-failure and kidney-related indications.

Renal function should be assessed before initiation and periodically thereafter. Dosing and whether treatment should be initiated depend on the indication and kidney function.

Important Warnings & Precautions

1. Diabetic Ketoacidosis

SGLT2 inhibitors can cause diabetic ketoacidosis (DKA), including cases where blood glucose is not markedly elevated.

Patients should seek urgent medical attention if they experience:

• Nausea or vomiting.
• Abdominal pain.
• Unusual fatigue or weakness.
• Difficulty breathing.
• Confusion.
• Excessive thirst or dehydration.

The risk may increase during prolonged fasting, severe illness, dehydration, excessive alcohol intake, markedly reduced carbohydrate intake, or around major surgery. ADA guidance recommends educating patients about DKA symptoms and appropriate risk-mitigation strategies.

2. Dehydration and Low Blood Pressure

Dapagliflozin increases urinary glucose and fluid excretion and may cause volume depletion, dizziness, hypotension, or dehydration, particularly in:

• Older adults.
• Patients receiving diuretics.
• Patients with impaired kidney function.
• Patients with low blood pressure.
• Patients experiencing vomiting, diarrhea, or inadequate fluid intake.

Volume status should be assessed and significant volume depletion corrected before treatment is initiated.

3. Genital Fungal Infections

Increased glucose excretion in urine can increase the risk of genital mycotic infections, including candidiasis.

Patients should seek medical advice if they develop genital itching, redness, discomfort, abnormal discharge, or other symptoms of infection.

4. Urinary Tract Infections

Urinary tract infections may occur during treatment. Fever, painful urination, blood in the urine, flank pain, or other significant urinary symptoms should be medically evaluated.

5. Kidney Function

Kidney function should be assessed before treatment and monitored as clinically appropriate.

The glucose-lowering effect of dapagliflozin becomes less pronounced as kidney function declines; however, cardiovascular and renal benefits may remain clinically relevant at lower eGFR levels for appropriate indications.

Temporary Interruption Before Surgery

Dapagliflozin should generally be withheld for at least 3 days before major surgery or procedures associated with prolonged fasting, when possible, to reduce the risk of ketoacidosis. Treatment can generally be resumed when the patient is clinically stable and has returned to normal oral intake, according to the treating healthcare professional.

Possible Side Effects

Potential adverse effects include:

Common or relatively frequent:

• Increased urination.
• Genital fungal infections.
• Urinary tract infections.
• Dizziness.
• Dehydration or increased thirst.
• Changes in blood pressure.

Important but less common:

• Hypoglycemia, particularly when combined with insulin or insulin secretagogues.
• Diabetic ketoacidosis.
• Significant volume depletion.
• Acute kidney injury in susceptible patients.
• Serious genital or perineal infections, which require urgent medical evaluation.

Hypoglycemia

Dapagliflozin alone generally has a low intrinsic risk of hypoglycemia because its glucose-lowering mechanism is not dependent on increasing insulin secretion.

However, hypoglycemia may become more likely when dapagliflozin is combined with insulin or insulin secretagogues such as sulfonylureas. The healthcare professional may need to adjust the dose of these medicines.

Contraindications & Important Situations

Dapagloznal should not be used in patients with a known hypersensitivity to dapagliflozin or any component of the formulation.

Dapagliflozin is not recommended for improving glycemic control in patients with type 1 diabetes mellitus, because of the risk of diabetic ketoacidosis.

Special medical supervision is required in patients with:

• Significant kidney impairment.
• Recurrent dehydration or low blood pressure.
• History of diabetic ketoacidosis.
• Frequent urinary or genital infections.
• Serious acute illness.
• Reduced oral intake or prolonged fasting.
• Planned major surgery.

Drug & Treatment Considerations

Patients should inform their physician or pharmacist about all prescription medicines, over-the-counter medicines, supplements, and herbal products they use.

Particular attention may be needed when dapagliflozin is combined with:

• Insulin or sulfonylureas — increased risk of hypoglycemia.
• Diuretics — increased risk of dehydration or hypotension.
• Other glucose-lowering medicines.
• Medicines affecting kidney function.

Adequate hydration should generally be maintained unless the patient's physician has prescribed fluid restriction.

Monitoring During Treatment

Depending on the patient's condition, the healthcare professional may monitor:

• Blood glucose and HbA1c.
• Kidney function/eGFR.
• Hydration and blood pressure.
• Symptoms of urinary or genital infection.
• Signs and symptoms of ketoacidosis.
• Electrolytes when clinically indicated.

For patients with type 2 diabetes and CKD, ADA 2026 guidance supports SGLT2 inhibitor therapy with demonstrated kidney benefit to reduce CKD progression and cardiovascular events.

Patient Disclaimer

This information is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Dapagloznal 10 mg is a prescription medicine and should be used only under the supervision of a qualified healthcare professional. The appropriate dose and indication depend on the patient's medical condition, kidney function, cardiovascular status, and other medications.

Do not start, stop, or change the dose without consulting your physician. Seek urgent medical attention if severe weakness, persistent vomiting, abdominal pain, difficulty breathing, confusion, severe dehydration, or other symptoms suggestive of diabetic ketoacidosis occur.

If surgery or prolonged fasting is planned, inform the healthcare professional that you are taking dapagliflozin.

References

• U.S. National Library of Medicine – DailyMed: Dapagliflozin tablets, current prescribing information.
• American Diabetes Association (ADA): Standards of Care in Diabetes—2026, Section 9: Pharmacologic Approaches to Glycemic Treatment.
• American Diabetes Association (ADA): Standards of Care in Diabetes—2026, Section 10: Cardiovascular Disease and Risk Management.
• American Diabetes Association (ADA): Standards of Care in Diabetes—2026, Section 11: Chronic Kidney Disease and Risk Management.
• World Health Organization (WHO): WHO guidance and resources on diabetes and cardiovascular/kidney risk management.

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