Gludapa Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication for both monotherapy and as an adjunct with other glucose-lowering agents including insulin is 10 mg once daily. When used in combination with insulin or insulin secretagogues such as sulfonylurea, lower doses of insulin or other insulin secretagogues may be considered to reduce the risk of hypoglycemia. For initial combination therapy, if there is no previous experience with diabetes medications, the initial recommended dose of this medication is either 5 mg once daily or 10 mg once daily when given in conjunction with metformin.

Child dose

The efficacy and safety of this medication in pediatric patients under 18 years of age have not been established.

This medication should not be used in patients who have had allergic reactions to the active ingredient or additives of this medication. It should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, or those on dialysis. Caution should be exercised when using in patients with low fluid volume or impaired kidney function, and renal function and fluid status should be checked before use. This medication can lower blood pressure and may affect kidney function, so symptoms of hypotension or changes in kidney function should be monitored regularly. In patients with moderate or severe kidney impairment, the blood sugar control effect may be reduced, therefore use is not recommended. This medication may increase the risk of genital infections and urinary tract infections, so if any symptoms of infection arise, the healthcare provider should be informed immediately. There is a risk of hypoglycemia, so careful consideration of dosage adjustments is needed when used with insulin or sulfonylurea drugs due to the risk of hypoglycemia. If symptoms of dehydration or hypotension due to decreased fluid volume occur, the administration of this medication should be temporarily halted and the condition should be restored. Serious metabolic disorders such as diabetic ketoacidosis may occur; immediate treatment should be sought if related symptoms (nausea, vomiting, abdominal pain, difficulty breathing, etc.) appear. Elderly patients or those on diuretics have a higher risk of fluid volume loss and hypotension and require additional caution. Pregnant or breastfeeding women should avoid using this medication, and it should be discontinued if pregnancy is confirmed. The safety and efficacy in pediatric patients have not been established, so it is generally not used. There is no specific antidote for overdose, so appropriate treatment should be given based on symptoms, and medical attention should be sought if necessary. This medication does not affect the ability to drive or operate machinery, but caution is required due to the risk of hypoglycemia when taken with insulin or sulfonylurea.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/conjunctival mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by coughing and fever, yellowing of skin or eyes (jaundice), severe fatigue, sudden and extreme headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination

Mild side effects

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It should also be kept away from extreme heat or cold, ideally stored at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

Bottle - 28 tablets/bottle, Box - 28 tablets/box[(7 tablets/Alu-Alu*4)]