Dapafopamine Sustained-release Tablet 10/500 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is once daily 10 mg of dapagliflozin/2000 mg of sustained-release metformin and is administered as 2 tablets of 5 mg/1000 mg. In cases where previous diabetes medication treatment experience is lacking and adequate blood sugar control is difficult with monotherapy, the recommended starting dose is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily.

This medication is used for diabetes treatment and should not be administered to patients with poor kidney function or impaired liver function. It can rarely cause a serious condition called lactic acidosis; therefore, it should be used cautiously while regularly undergoing tests related to kidney function. When used with insulin or sulfonylurea medication, there is a risk of hypoglycemia, so blood sugar levels should be checked frequently, and dosage adjustments may be necessary. Patients with reduced fluid volume or those at risk of low blood pressure should carefully monitor for dehydration symptoms or changes in blood pressure while using this medication. This medication may increase the risk of genital infections or urinary tract infections. If infection symptoms appear, consult a doctor immediately. Women who are pregnant or breastfeeding should not use this medication and should discontinue administration if pregnancy is planned or confirmed. Elderly patients have a higher risk of renal function decline, so the dosage of this medication should be determined carefully, and kidney function should be monitored regularly. During administration of this medication, excessive alcohol consumption should be avoided, and administration should be paused for a certain period before and after surgery or iodinated radiation imaging tests. In case of overdose, seek medical attention immediately for appropriate treatment, as this medication is eliminated through the kidneys, so monitoring kidney function is important. This medication has not been established for safety and efficacy in children and should not be used in this population. Additionally, this medication may cause vitamin B12 deficiency, so it is advisable to monitor blood vitamin B12 levels during long-term use. During usage, be cautious of dizziness or hypoglycemia symptoms, especially when driving or operating machinery. This medication should be stored in its original container and kept in a safe place out of the reach of children.

Serious side effects

Severe lactic acidosis (lactic acidosis), severe hypoglycemia, diabetic ketoacidosis, acute kidney injury and renal dysfunction, urosepticemia and pyelonephritis, perineal necrosis, severe allergic reactions, severe skin adverse reactions, severe edema or urinary abnormalities, serious neurological symptoms, liver abnormalities (jaundice), respiratory problems, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, acute cholecystitis, atrial fibrillation

Mild side effects

• Hypoglycemia
• dizziness
• constipation
• dry mouth
• lower back pain
• dysuria
• polyuria
• nocturia
• vulvar pruritus
• genital pruritus

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advised to keep it at room temperature, between 1 degree and 30 degrees Celsius.

Appearance

Pink, convex on both sides, rectangular sustained-release film-coated tablet

Package unit

30 tablets/box [6 tablets/PTP (Alu-Alu) × 5]