Exiglumem Sustained-release Tablet 10/1000 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is once daily 10 mg of dapagliflozin and 2000 mg of sustained-release metformin, dosed as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is one tablet of either 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually. Patients with renal impairment should have their doses adjusted as appropriate.

This medication is used for the treatment of diabetes and should not be used in patients with poor kidney function or certain severe conditions. This medication may very rarely cause a serious side effect known as lactic acidosis, which can be life-threatening; therefore, kidney function and overall health status should be monitored regularly. Caution is also needed as combining this medication with other diabetes treatments may increase the risk of hypoglycemia. Special care should be exercised when administering to patients with low blood pressure or fluid deficiency, elderly patients, and those with decreased kidney function, and both kidney function and blood pressure status should be closely monitored before and after administration. This medication may increase the risk of genital and urinary tract infections, and if any related symptoms occur, immediate consultation with healthcare personnel is required. Women who are pregnant or breastfeeding should not use this medication, and if planning to become pregnant, should consult with their healthcare provider. Excessive alcohol consumption should be avoided while taking this medication, as alcohol intake can increase the risk of lactic acidosis. Because there is a risk of vitamin B12 deficiency, it is advisable to monitor serum vitamin B12 levels during long-term use. This medication may need to be temporarily discontinued prior to surgery or diagnostic testing with radiopaque agents, and should be resumed only after confirming that kidney function is normal. In case of overdose, seek medical attention immediately for appropriate treatment; this medication can be removed through dialysis. The safety and efficacy of this medication in children and elderly patients have not been adequately established, hence caution is warranted. This medication does not significantly affect the ability to drive or operate machinery, but caution should be taken as symptoms such as dizziness may occur. Finally, this medicine should be stored in its original container and kept out of reach of children.

Serious side effects

Lactic acidosis, severe hypoglycemia, severe allergic reactions, acute kidney injury, renal failure, diabetic ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, acute cholecystitis, atrial fibrillation, cardiac disorders, severe edema, coma, acute myocardial infarction, sepsis, liver abnormalities (jaundice), severe skin reactions (severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa), respiratory

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, elevated hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, elevated serum creatinine at the beginning of treatment, elevated blood urea, weight loss, upper abdominal pain, dyspepsia, abdominal discomfort, diarrhea, constipation

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is recommended to store it at room temperature between 1°C and 30°C. By storing it this way, the effectiveness of the medication is preserved for a longer duration and deterioration can be prevented.

Appearance

A yellow to dark yellow, bilayered, oval sustained-release film-coated tablet that is convex on both sides.

Package unit

10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]