Dapagliflozin and Metformin Extended-Release Tablets 10/500 mg

Adult dose

The dosage of this medication should be individualized based on the patient's current therapy, efficacy, and tolerance, without exceeding the maximum recommended doses of 10 mg of dapagliflozin and 2000 mg of extended-release metformin. This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, taken as 2 tablets of 5 mg/1000 mg.

This medication contains metformin hydrochloride and dapagliflozin for the management of blood sugar in patients with Type 2 diabetes. Care must be taken when taking this medication as there is a risk of a rare complication known as severe lactic acidosis. Lactic acidosis can be life-threatening, so immediate consultation with a physician is necessary if symptoms occur. Additionally, when taken with insulin or sulfonylurea medications, the risk of hypoglycemia may increase, so careful monitoring of blood sugar changes is advised. This medication should not be taken by patients with moderate or worse renal impairment, acute heart disease, severe infection, or dehydration. Particularly, the decision to administer should be based on renal function test results, requiring regular monitoring of renal function. This medication should be temporarily discontinued before and after surgery or examinations using contrast agents and resumed only after normal renal function is confirmed. Pregnant or breastfeeding women should not use this medication, and it is contraindicated in patients with certain genetic conditions such as lactose intolerance. Due to the potential for decreased fluid volume and hypotension, caution is advised for elderly patients or those on diuretics or with low blood pressure. Notify healthcare personnel immediately if symptoms of dehydration or hypotension occur. During treatment, genital and urinary infections may occur; therefore, prompt treatment is required if any infection symptoms or discomfort arise. The metformin component may result in vitamin B12 deficiency, so regular monitoring of vitamin B12 levels is recommended during prolonged use. The risk of lactic acidosis increases with alcohol consumption; therefore, it is advised to avoid or limit alcohol intake. Due to the risk of hypoglycemia, especially when combined with insulin or sulfonylureas, patients should be vigilant about hypoglycemic symptoms and may require dose adjustments as necessary. In case of overdose, seek medical help immediately for appropriate treatment, as this medication can be removed through dialysis, making prompt treatment crucial. Lastly, store this medication out of reach of children and keep it in its original container to maintain quality.

Serious side effects

• Lactic acidosis
• severe hypoglycemia
• worsening renal function
• acute kidney injury
• severe edema
• diabetic ketoacidosis
• urosepsis
• pyelonephritis
• severe allergic reactions
• severe skin adverse reactions

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. Avoid storing it in excessively hot or cold environments, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

Pink, oblong film-coated bilayer tablets consisting of a fast-release layer and a slow-release layer

Package unit

30 tablets/bottle