Dapaglu Tablet 10 mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dose of this medication for monotherapy and additional combination therapy with insulin and other antidiabetic agents is 10 mg once daily. When this medication is used in combination with insulin or other insulin secretagogues like sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. In cases where patients have no prior experience with diabetes medications, the initial recommended dose when administered in combination with metformin is 5 mg once daily or 10 mg once daily.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established. There is no related data.

This medication should not be used in patients who are allergic to the active ingredient or excipients. Patients with Type 1 diabetes or diabetic ketoacidosis should not take this medication as it can be dangerous. Contains anhydrous lactose; should not be administered to patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients undergoing dialysis should avoid using this medication. Patients with decreased fluid volume or renal function must evaluate these conditions before taking the medication and should closely monitor for symptoms of hypotension and changes in renal function. Patients with moderate to severe renal impairment may find reduced effectiveness in blood sugar control, requiring caution. This medication may increase the risk of genital and urinary tract infections; immediate treatment should be sought if symptoms appear. When taken with drugs that have a risk of hypoglycemia, symptoms of hypoglycemia may occur, requiring dose adjustments of insulins or sulfonylureas. This medication can lower blood pressure due to decreased fluid volume, so caution is necessary for the elderly or those on diuretics. Rare but severe complications such as diabetic ketoacidosis may occur; if symptoms like vomiting, abdominal pain, or dyspnea appear, inform medical professionals immediately. Rare but serious infections like necrotizing fasciitis can occur; if there is pain, redness, or swelling around the genital area or perineum, seek treatment immediately. Pregnant women should avoid using this medication, and it should be discontinued if pregnancy is confirmed. Breastfeeding women should also avoid this medication. In case of overdose, there is no specific antidote; treatment should be symptomatic, and in severe cases, medical assistance should be sought. This medication generally does not significantly affect the ability to drive or operate machinery, but caution is advised when taken with hypoglycemic drugs. Lastly, the safety and efficacy of this medication in children have not been confirmed, so it is advisable not to administer it to minors.

Serious side effects

• Decreased fluid volume (including dehydration, hypovolemia, hypotension)
• Diabetic ketoacidosis
• Necrotizing fasciitis (Fournier's gangrene)
• Acute kidney injury and renal impairment
• Angioedema
• Anaphylaxis
• Severe allergic reactions
• Severe skin adverse reactions
• Respiratory issues
• Liver abnormalities (jaundice)

Mild side effects

• Vulvovaginitis, balanitis, and related genital infections
• Urinary tract infections
• Hypoglycemia (when used with sulfonylureas or insulin)
• Thirst
• Dizziness
• Constipation
• Dry mouth
• Lumbago
• Dysuria
• Polyuria

This medication should be stored in a tightly closed container to prevent moisture or air exposure, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevents degradation.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 90 tablets/bottle