Posiromet Extended-Release 5/500 mg (Dapagliflozin, Metformin Hydrochloride)

Adult dose

This medication is generally administered once daily with dinner. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, given as 2 tablets at 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects from metformin, the dosage should be adjusted gradually.

This medication contains metformin hydrochloride and dapagliflozin and is primarily used for blood sugar control in patients with type 2 diabetes. Severe lactic acidosis, a rare side effect, may occur while taking this medication, so patients with impaired kidney function, serious infections, or dehydration should be particularly cautious. Additionally, when taken with insulin or sulfonylureas, the risk of hypoglycemia may increase, so dosage adjustments may be necessary if taking these medications together. Patients with moderate to severe kidney impairment, liver dysfunction, acute conditions like myocardial infarction or sepsis, and patients with type 1 diabetes should not use this medication. Patients scheduled for surgery or receiving radiological contrast agents should temporarily discontinue this medication 48 hours before the procedure or examination, and resume only after confirming normal kidney function. This medication can cause decreased fluid volume and hypotension, thus elderly patients, those taking diuretics, and patients with cardiovascular diseases need to exercise extra caution when taking it. During treatment, infections such as genital infections or urinary tract infections may occur; any related symptoms should be reported to a healthcare professional immediately. The metformin component can lower vitamin B12 levels, so checking vitamin B12 concentrations regularly during long-term treatment is advisable. Pregnant or potentially pregnant women, as well as breastfeeding women, should not take this medication, and if pregnancy is confirmed, should discontinue immediately. Excessive alcohol consumption can increase the risk of side effects associated with this medication, so caution is advised. Dizziness or hypoglycemic symptoms may occur while taking this medication, so caution is needed when driving or operating machinery. Finally, this medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

Serious side effects

• Lactic acidosis
• severe hypoglycemia
• severe edema
• acute kidney injury
• renal dysfunction
• severe allergic reactions
• ketoacidosis
• urosepsis
• pyelonephritis
• perineal necrosis

Mild side effects

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. A storage temperature between 1 to 30 degrees Celsius at room temperature is recommended to maintain the medication's effectiveness over time.

Appearance

Orange, rectangular extended-release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP) x 5]