Trudapa Tablet 10 mg (Dapagliflozin Bis Proline)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other glucose-lowering agents. For initial combination therapy, if there has been no previous experience with diabetes medication, 5 mg or 10 mg can be administered once daily in combination with metformin. The recommended dose for patients with chronic heart failure and chronic kidney disease is 10 mg once daily. For patients with severe liver dysfunction, a starting dose of 5 mg is recommended.

Child dose

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

This medication should not be used in patients who have had allergic reactions to the active ingredient or excipients. It should not be administered to type 1 diabetes patients or patients with diabetic ketoacidosis. This drug contains anhydrous lactose and should not be used in patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It should also not be administered to patients undergoing dialysis. Careful administration is required in patients with reduced fluid volume or kidney dysfunction, and fluid status and kidney function should be closely monitored before and after administration due to the potential for hypotension or worsening of kidney function. In particular, in patients with moderate to severe kidney function impairment, the glucose control effect may decrease, and it is not recommended for patients with very low kidney function. While taking this medication, there may be an increased risk of genital infections and urinary tract infections; therefore, immediate treatment should be sought if any infection symptoms arise. There is a risk of hypoglycemia; hence, dosage adjustment may be necessary when taken with insulin or insulin secretagogues. Symptoms of dehydration or hypotension may occur due to reduced fluid volume, so special caution is needed for elderly patients or those taking diuretics. Diabetic ketoacidosis may occur, so immediate medical consultation is required if symptoms such as nausea, vomiting, abdominal pain, or shortness of breath appear. It is advisable for pregnant or breastfeeding women to avoid this medication, and it should be discontinued upon confirmation of pregnancy. The safety and efficacy of this drug in pediatric patients have not been established. There is no specific antidote for overdose; appropriate treatment should be provided based on symptoms, and it is unclear whether this drug can be removed by dialysis. This medication has minimal effects on driving or operating machinery, but caution is needed when combined with medications that pose hypoglycemia risks. Store the product out of the reach of children, and keep it in its original container to maintain quality.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing associated with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, lumbar pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, increased hematocrit, decreased serum creatinine clearance early in treatment, dyslipidemia, increased blood creatinine early in treatment, increased blood urea, weight loss, urticaria, cold sweat, dermatitis, dry skin, overdose

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. This will help preserve the drug's efficacy and prevent degradation.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

Bottle package - 30 tablets/bottle, bottle package - 100 tablets/bottle