Gludapa Tablet 10mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this medication is 10mg once daily for monotherapy and additional combination therapy with other blood glucose-lowering agents such as insulin. For initial combination therapy, when there is no prior experience with diabetes medications, administer either 5mg or 10mg once daily when combined with metformin. There are criteria for dosage adjustments based on renal impairment, liver impairment, and elderly patients, and administration can be taken at any time of day regardless of food intake.

Child dose

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

This medication should not be used by patients who are allergic to the active ingredient or excipients, those with type 1 diabetes, diabetic ketoacidosis patients, or patients undergoing dialysis. The medication should be administered cautiously to patients with reduced fluid volume or impaired kidney function, and blood pressure, fluid status, and kidney function should be thoroughly checked before and after administration. The blood sugar control effect of this medication varies according to kidney function, and the effect may decrease in patients with significantly impaired kidney function. The most commonly observed side effect in clinical trials is genital infections, which may occur more frequently in women or patients with a history of infections. Hypoglycemia is rarely encountered when this medication is used alone, but the risk of hypoglycemia may increase when taken in conjunction with insulin or sulfonylureas, requiring caution. Symptoms of dehydration and low blood pressure due to decreased fluid volume may occur, so elderly patients or those taking diuretics should closely monitor their fluid status. Diabetic ketoacidosis may rarely occur, and even if blood sugar is within normal ranges, if symptoms of ketoacidosis appear, immediate medical attention is necessary. Severe urinary tract infections, such as urinary tract infection and pyelonephritis, have been reported, so prompt treatment is necessary if infection symptoms arise. This medication may affect kidney function, potentially raising creatinine levels, necessitating regular kidney function tests during administration. A rare but serious infection called Fournier's gangrene may occur, so immediate medical attention is needed if pain, swelling, or redness appear around the perineum. Pregnant women should not use this medication, and it must be discontinued if pregnancy is confirmed. Breastfeeding women are also advised against taking this medication. The risk of hypoglycemia increases when this medication is taken alongside insulin or sulfonylureas, so dosage adjustments may be necessary for these medications. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms, and it is not removable through dialysis. Caution should be exercised for symptoms of hypoglycemia while driving or operating machinery during the use of this medication. Lastly, this medication has not established safety and efficacy in children, so it is not to be used in pediatrics.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms along with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. This will ensure the medication's effectiveness is preserved safely.

Appearance

Yellow, diamond-shaped, film-coated tablet with both sides convex

Package unit

Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [7 tablets/Alu-Alu x 4]