Diadap5 mg

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used, depending on the specific approved indication, for:

• Improving blood glucose control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise
• Reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction, regardless of diabetes status
• Reducing the risk of sustained decline in kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of disease progression, regardless of diabetes status

Dapagliflozin is not indicated for type 1 diabetes or diabetic ketoacidosis.

Contains dapagliflozin (as Diadap 5 mg monohydrate) as the active ingredient, available as oral film-coated tablets, commonly in 5 mg and 10 mg strengths.

Dapagliflozin is an oral medicine that lowers blood glucose by causing the kidneys to remove more glucose from the body through the urine, working independently of insulin. Beyond its glucose-lowering effect, dapagliflozin has been shown to reduce the risk of hospitalization for heart failure and to slow the progression of chronic kidney disease, which is why it is now also approved for these conditions in patients with or without diabetes. It carries recognized risks of genital and urinary tract infections, and, less commonly, diabetic ketoacidosis, which can occur even with near-normal blood glucose levels.

Therapeutic Class: Antidiabetic / Cardiorenal Protective Agent

Dapagliflozin selectively inhibits SGLT2, the transporter responsible for the majority of glucose reabsorption in the kidney's proximal tubule. By blocking this transporter, more glucose is excreted in the urine, which lowers blood glucose in a manner that does not depend on insulin secretion or action, giving it a low intrinsic risk of hypoglycemia when used alone. It also has natriuretic (sodium-excreting) and mild diuretic effects, contributing to its cardiovascular and renal benefits independent of its glucose-lowering action.

• Taken orally, once daily, at any time of day, with or without food
• Take at approximately the same time each day
• If a dose is missed, take it as soon as remembered on the same day; do not take two doses on the same day to make up for a missed dose
• Maintain adequate fluid intake, particularly during illness or reduced oral intake, given the diuretic-like effect

The following should be assessed by a healthcare professional before combining with dapagliflozin:

• Insulin or insulin secretagogues (such as sulfonylureas): combined use increases the risk of hypoglycemia; a lower dose of the insulin or secretagogue may be considered to reduce this risk.
• Diuretics: dapagliflozin has a mild diuretic effect, and combining with other diuretics may increase the risk of dehydration and low blood pressure, particularly in elderly patients.
• Lithium: SGLT2 inhibitors may decrease lithium blood levels; monitoring may be needed.
• Iodinated contrast media: caution is advised, given the general risk of acute kidney injury with contrast procedures in patients with reduced kidney function.

Common side effects

• Genital yeast (mycotic) infections
• Urinary tract infections
• Increased urination
• Back pain
• Nasopharyngitis (common cold-type symptoms)

Serious side effects (seek urgent medical attention)

• Diabetic ketoacidosis: can occur even with blood glucose levels that are only mildly elevated or near-normal ("euglycemic DKA"); symptoms include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual tiredness or sleepiness - stop the medicine and seek immediate medical attention if these occur.
• Necrotizing fasciitis of the perineum (Fournier's gangrene): a rare but serious and life-threatening genital/perineal infection; seek immediate medical attention for tenderness, redness, or swelling of the genital or perineal area, especially with fever or feeling unwell.
• Urosepsis and pyelonephritis (serious kidney/urinary infections).
• Signs of acute kidney injury: decreased urination, swelling of the legs or feet.
• Signs of dehydration or low blood pressure: dizziness, particularly on standing.
• Signs of severe hypoglycemia if combined with insulin or a sulfonylurea: confusion, sweating, shakiness.

Pregnancy

Dapagliflozin is not recommended during pregnancy, based on animal data suggesting potential effects on kidney development during the period corresponding to the second and third trimesters of human pregnancy. If pregnancy is planned or confirmed, discuss alternative treatment with your doctor.

Breastfeeding

Dapagliflozin is not recommended during breastfeeding, given limited safety data and animal data suggesting potential effects relevant to a developing kidney.

• Diabetic ketoacidosis: can occur even with near-normal blood glucose; assess for ketones in patients presenting with nausea, vomiting, abdominal pain, or unusual fatigue, regardless of blood glucose level; discontinue promptly if DKA is suspected or confirmed, and consider temporarily stopping before scheduled surgery or during acute serious illness.
• Necrotizing fasciitis of the perineum (Fournier's gangrene): assess promptly for this rare, life-threatening infection if genital or perineal pain, tenderness, redness, or swelling occurs, particularly with fever.
• Genital and urinary tract infections: monitor for and treat promptly; good genital hygiene may help reduce risk.
• Volume depletion: use with caution in elderly patients, those with low blood pressure, or those on diuretics, given the diuretic-like effect.
• Sick-day guidance: patients should be advised to seek medical advice during periods of significant illness or reduced fluid/food intake, since medical management may need to change temporarily.
• Monitor renal function before starting and periodically during treatment.

Overdose would be expected to increase the risk of excessive urination, dehydration, low blood pressure, and, particularly in combination with insulin or sulfonylureas, hypoglycemia. Suspected significant overdose should be evaluated by a healthcare professional; treatment is generally supportive, appropriate to the clinical presentation, including monitoring for signs of ketoacidosis.

Store at controlled room temperature (generally 20-25°C, with excursions permitted between 15-30°C), protected from moisture, in the original container.

• Renal impairment: Not recommended for glycemic control when eGFR is below 45 mL/min/1.73m², given reduced effectiveness at lower kidney function; may still be used for heart failure or chronic kidney disease indications at lower eGFR thresholds with appropriate monitoring, and is contraindicated in dialysis-dependent patients.
• Elderly: More susceptible to volume depletion and its consequences (dizziness, low blood pressure); use with caution and monitor closely.
• Hepatic impairment: No dose adjustment is generally required for mild to moderate impairment; use with caution in severe impairment given limited data.

Dapagliflozin is generally used as ongoing, long-term therapy for type 2 diabetes, heart failure, or chronic kidney disease, for as long as it is tolerated and clinically beneficial, with periodic reassessment of kidney function and overall response by the treating physician.

Drug Class: Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Dapagliflozin blocks SGLT2 proteins in the kidney that would otherwise reabsorb glucose back into the bloodstream, causing excess glucose to be excreted in the urine instead, which lowers blood sugar. This same mechanism produces mild diuretic and blood-pressure-lowering effects, and is thought to reduce strain on the heart and kidneys over time, which is the basis for its additional approved uses in heart failure and chronic kidney disease, even in people without diabetes.

Safety and effectiveness of dapagliflozin have not been well established in patients younger than 18 years for most indications; use in children should follow the specific product's current approved labeling and specialist guidance where relevant.