Dapagliflozin/Metformin Extended-Release Tablets 10/1000 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 1 daily dose of dapagliflozin 10 mg/metformin extended-release 2000 mg, which is administered as 2 tablets of 5 mg/1000 mg. If there is no previous experience with diabetes medication and adequate blood sugar control is difficult with monotherapy, the initial regimen is to take 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. Gastrointestinal side effects of metformin should be minimized by gradually adjusting the dose.

This medication helps control blood sugar. However, during treatment, there is a very rare risk of a severe condition known as lactic acidosis. Lactic acidosis occurs when lactic acid builds up excessively in the body, which can be very dangerous and may lead to death, so any symptoms should be reported to a doctor immediately. Additionally, if taken with insulin or sulfonylurea drugs, the risk of hypoglycemia may increase, requiring caution. Hypoglycemia can cause dizziness or even loss of consciousness due to excessively low blood sugar, so symptoms should be closely monitored. This medication should not be taken by patients with severely impaired kidney function, dehydration, severe infections, heart conditions, type 1 diabetes, pregnant or breastfeeding women, or patients with lactose intolerance. Before surgery or tests involving iodinated contrast media, this medication should be temporarily discontinued, and it should only be restarted after verifying that kidney function is normal following surgery. This medication can cause dehydration or low blood pressure, so elderly patients or those taking diuretics should regularly monitor their fluid status and blood pressure. During treatment, genital infections or urinary tract infections may occur, and any related symptoms should be treated immediately. Weight loss may occur, so weight changes should be closely monitored. This medication can cause vitamin B12 deficiency, so for long-term use, it is advisable to regularly test blood vitamin B12 levels. Excessive alcohol consumption should be avoided, and any sudden changes in health status, infections, or surgical situations should prompt consultation with a doctor for possible adjustments to medication. The safety and efficacy of this medication in children have not been established, and in the elderly, declining kidney function is common, so dosage should be adjusted carefully. In cases of overdose, seek medical attention immediately, and keep this medication out of the reach of children.

Serious side effects

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

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, fungal infection, hypoglycemia (when used with sulfonylureas or insulin), volume depletion, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, increased hematocrit, decreased initial renal creatinine clearance, dyslipidemia, increased serum creatinine at the start of treatment, blood urea nitrogen increase

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be stored at room temperature, neither too hot nor too cold, ideally between 1 to 30 degrees Celsius.

Appearance

Biconvex oval film-coated tablets, yellow to deep yellow in color

Package unit

30 tablets/box [6 tablets (Alu-Alu) x 5], 30 tablets/bottle