Dapagliflozin/Metformin Extended-Release Tablet 10/500 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is one daily dose of dapagliflozin 10 mg/metformin extended-release 2000 mg, administered as two tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dosage adjustments should be done gradually.

This medication is a drug for the treatment of diabetes, with one of the active ingredients being metformin hydrochloride and the other being dapagliflozin. While rare, serious lactic acidosis may occur when taking this medication, therefore caution is advised. Lactic acidosis is a dangerous condition caused by excessive buildup of acid in the body, which can sometimes be life-threatening. Additionally, taking this medication with insulin or sulfonylurea agents can pose a risk of hypoglycemia, meaning blood sugar may drop too low, so special care must be taken. This medication should not be given to certain patients. For example, patients who are allergic to this medication or its ingredients, those with severely impaired kidney function, dehydration status, severe infections, very poor heart function, individuals with type 1 diabetes, pregnant or breastfeeding women, and patients genetically incapable of digesting certain sugars should not take this medication. Patients with mildly reduced kidney function or depleted fluid volume should be cautious when taking this medication, and regular tests should be followed according to a doctor's instructions due to the potential for blood pressure drops or worsening kidney function. During the use of this medication, there may be occurrences of genital or urinary infections, so consult a healthcare provider immediately if infection symptoms appear. Furthermore, this medication can lower vitamin B12 levels, hence patients on long-term treatment should have their vitamin B12 levels regularly checked. Excessive alcohol intake can increase the risk of side effects, so alcohol consumption should be avoided while on this medication. Prior to surgery or tests involving radiographic contrast agents, this medication should be discontinued for a period of time, and it should be resumed only after confirming normal kidney function post-surgery. Elderly patients or those with impaired kidney function need to pay extra attention and require careful monitoring for symptoms of hypoglycemia or dehydration. Lastly, this medication should be kept out of reach of children and stored in its original container to prevent misuse or quality deterioration.

Serious side effects

Severe lactic acidosis, severe hypoglycemia, acute conditions that may affect kidney function, acute myocardial infarction, shock, lactic acidosis, cardiovascular collapse, severe infections, acute kidney injury, renal impairment, symptoms associated with lactic acidosis (fatigue, myalgia, dyspnea, weakness, abdominal pain, hypothermia, hypotension, resistant bradyarrhythmias), life-threatening perineal necrosis, severe allergic reactions, ketoacidosis, urinary sepsis, and pyelonephritis.

Mild side effects

Vulvitis, balanitis and related genital infections, urinary infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, lower back pain, dysuria, polyuria, nocturia, genital itching, vaginal itching, increased hematocrit, decreased initial kidney creatinine clearance, dyslipidemia, initial increase in blood creatinine, elevated blood urea, weight loss, diarrhea, nausea/vomiting, decreased/deficiency of vitamin B12

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

Pink, biconvex, oval film-coated tablet

Package unit

30 tablets/bottle