Dapaen 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended adult dosage is 10 mg once daily. For initial combination therapy, the dosage may be 5 mg once daily or 10 mg once daily. Patients with chronic heart failure and chronic kidney disease are also administered 10 mg once daily. In patients with severe liver impairment, a starting dose of 5 mg is recommended and may be increased to 10 mg if well tolerated. Dosage adjustments based on age are not recommended. This medication can be taken without regard to food intake.

Child dose

There is no relevant data as the efficacy and safety in pediatric patients under 18 years of age have not been established.

This medication should not be used in patients with allergies to its active ingredient or excipients or in those with type 1 diabetes or diabetic ketoacidosis. Additionally, patients with genetic lactase deficiency or those undergoing dialysis should not take this medication. This medication should be used cautiously in patients with reduced fluid volume or impaired kidney function. It can lower blood pressure or affect kidney function, especially requiring more attention in elderly patients or those taking specific diuretics. Fluid status and kidney function should be assessed before starting treatment, and symptoms of hypotension and kidney function should be regularly monitored during treatment. Side effects may include genital infections, urinary tract infections, hypoglycemia, reduction in fluid volume, and ketoacidosis. Genital infections are particularly common in females and those with a history of previous infections. In severe cases, a serious infection called perineal gangrene (Fournier's gangrene) may occur, so if pain, swelling, or redness occurs around the genital area, immediate consultation with a healthcare provider is necessary. The risk of hypoglycemia may increase when this medication is used in conjunction with insulin or sulfonylureas, so dosage adjustments of these drugs may be necessary. Pregnant or lactating women should not take this medication, and treatment should be discontinued upon confirmation of pregnancy. The safety and efficacy of this medication in pediatric patients have not yet been established, so its use is not recommended. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms, and healthcare providers should be notified immediately if needed. Care should be taken during driving or operating machinery while taking this medication, particularly if there is a risk of hypoglycemia. Finally, this medication should be kept out of reach of children and stored in its original container to maintain quality.

Serious side effects

Diabetic ketoacidosis, perineal gangrene (Fournier's gangrene), reduction of fluid volume (dehydration, hypovolemia, hypotension), acute kidney injury, renal impairment, urosepsis, pyelonephritis, urticaria, angioedema, anaphylaxis, severe rash accompanied by fever, blistering, skin peeling, oral/ocular mucosal pain, severe swelling (edema), chest tightness, difficulty breathing, sweating, pallor, sudden and severe headache, lightning pain

Mild side effects

• Vulvitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• back pain
• dysuria

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets - 30 tablets/bottle