Dapeldi DM Tablet 10 mg (Dapagliflozin Anhydrous Lactose Mixture)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and in combination therapy with other blood glucose-lowering agents such as insulin. When initiating combined therapy with metformin, the recommended starting dose is either 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the recommended dose is once daily at 10 mg. For patients with severe liver impairment, a starting dose of 5 mg is recommended; if well tolerated, it may be increased.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established. There is no relevant data.

This medication should not be used in certain patients. For instance, individuals who are allergic to the main ingredients or additives of this medication, as well as patients with type 1 diabetes or diabetic ketoacidosis, should not take this drug. Additionally, it contains anhydrous lactose, so patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should avoid its use. Patients undergoing dialysis should also not use this medication. Patients with reduced fluid volume or kidney function issues should use this medication cautiously, as it may lower blood pressure or reduce blood volume, potentially causing symptomatic hypotension or changes in kidney function. Older adults with decreased kidney function or patients taking diuretics should be particularly cautious and monitor fluid status and kidney function carefully both before and after treatment initiation. This medication contains color additives Yellow 4 and Yellow 5, and patients allergic to these substances should use it with caution. Side effects may include genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, diabetic ketoacidosis, and abnormal kidney function. Genital infections, especially, are more common in women, and those with a history of infections may have a higher recurrence rate. Hypoglycemia may occur more frequently when used with medications such as insulin or sulfonylureas, and dosage adjustments may be necessary. Additionally, this medication can reduce fluid levels and may cause dehydration or hypotension, so it is essential to monitor fluid status closely and temporarily discontinue the medication if necessary. Diabetic ketoacidosis may occur even when blood sugar levels are not elevated, so if symptoms such as vomiting, abdominal pain, or difficulty breathing arise, immediate medical attention is required. This medication is not recommended for patients with severely impaired liver function or for pregnant women, and it should also be avoided during breastfeeding. Elderly patients or those with reduced kidney function should be particularly vigilant in observing kidney function and fluid status when taking this medication. This medication can increase the risk of hypoglycemia when used in conjunction with insulin or sulfonylureas, necessitating dosage adjustment during co-administration. There is no specific antidote for overdose, so it is vital to receive appropriate treatment based on symptoms. Finally, the safety and efficacy of this medication in children have not been established, hence it is advisable to avoid use in this population.

Serious side effects

Diabetic ketoacidosis, acute kidney injury, renal impairment, hepatic dysfunction (symptoms of jaundice not specified but includes interstitial nephritis, etc.), perineal necrosis (Fournier's gangrene), urosepsis and pyelonephritis, anaphylactic reactions, angioedema, severe allergic reactions (urticaria, significant swelling, chest tightness, breathing difficulties, sweating, pallor), severe neurological symptoms (seizures, confusion, visual disturbances, audible disturbances)

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• back pain
• painful urination

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best stored at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness and safety of the medication.

Appearance

Yellow, film-coated tablets shaped like convex rhombuses on both sides

Package unit

28 tablets/PTP [14 tablets/PTP × 2], 30 tablets/bottle