Dapagliflozin Metformin Extended-Release Tablets 5/1000 mg

Adult dose

This medication is typically taken once daily with the evening meal. The maximum dose is dapagliflozin 10mg/extended-release metformin 2000mg taken as 2 tablets of 5mg/1000mg. If there is no prior experience with diabetes medication treatment, the initial regimen is to take 1 tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects from metformin, dosage should be adjusted gradually.

This medication is used for the treatment of diabetes and should not be used in patients with impaired kidney function or certain health conditions. In particular, it should not be administered to patients with moderate to severe renal impairment, severe infection or dehydration, heart failure, acute myocardial infarction, sepsis, or type 1 diabetes. Pregnant or breastfeeding women should also avoid this medication, and patients undergoing surgery should discontinue it 48 hours prior to surgery and resume only after confirming normal kidney function. This medication can rarely cause a serious condition known as lactic acidosis, so both patients and healthcare providers should be aware of the symptoms of lactic acidosis, and any symptoms should prompt immediate medical attention. When used in conjunction with other diabetes medications, the risk of hypoglycemia may increase; therefore, dose adjustments may be necessary when combined with insulin or sulfonylureas. Patients with reduced fluid volume or low blood pressure, elderly patients, and those with impaired kidney function should regularly monitor kidney function and blood pressure before and during treatment. This medication may increase the risk of genital infections or urinary tract infections, so immediate treatment should be sought if infection symptoms develop, and patients with a history of recurrent infections should exercise greater caution. A deficiency in vitamin B12 may occur, so regular monitoring of vitamin B12 levels is advised during prolonged use. Excessive alcohol consumption can increase the risk of side effects from this medication, so it is advisable to avoid alcohol while taking it. Regular monitoring of blood glucose control is necessary during treatment, and any sudden changes in symptoms should be discussed with a healthcare provider immediately. Lastly, this medication should not be used in children as its safety and efficacy have not been established, and special caution should be taken when prescribing to the elderly due to the potential for reduced kidney function.

Serious side effects

• Severe lactic acidosis
• severe hypoglycemia
• dehydration
• hypovolemia
• hypotension
• diabetic ketoacidosis
• ketosis
• urosepsis
• pyelonephritis
• acute kidney injury

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 itching, genital itching, elevated hematocrit, decreased creatinine clearance at the start of treatment, dyslipidemia, increased serum creatinine at the start of treatment, elevated blood urea, weight loss, diarrhea, nausea/vomiting, decreased/deficiency of vitamin B12

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Dark pink, oval, biconvex, film-coated tablets

Package unit

30 tablets/bottle