Dapagloem Extended-Release Tablet 10/500 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/extended-release metformin 2000 mg once daily, and 2 tablets of 5 mg/1000 mg. The recommended starting dose when used as initial therapy is 1 tablet of either 5 mg/500 mg or 10 mg/500 mg once daily. To minimize gastrointestinal side effects of metformin, the dosage should be increased gradually.

This medication aids in glucose control. However, it is necessary to be cautious as it may rarely lead to a serious condition called lactic acidosis. Care should be taken when taken alongside insulin or sulfonylurea medications as it may exacerbate hypoglycemia. It should not be used in patients with severely impaired renal function, dehydration, severe infections, or cardiovascular issues. Additionally, it should not be used in pregnant or breastfeeding women, nor in patients with genetic issues such as lactose intolerance. Patients with reduced fluid volume or impaired renal function should use this medication with caution and check periodically for symptoms of hypotension or changes in renal function. This medication may increase the risk of genital infections or urinary tract infections, so immediate treatment is necessary if symptoms appear. Moreover, this drug can decrease vitamin B12 levels, so it is advisable to check vitamin B12 concentrations during prolonged use. Excessive alcohol consumption should be avoided during treatment, and the medication should be temporarily discontinued prior to surgery or radiographic contrast examinations. Dose adjustments may be required when used alongside medications that pose a risk of hypoglycemia. This medication has not been sufficiently evaluated for safety and efficacy in children or elderly patients, hence caution is required. In case of overdose, seek appropriate medical care immediately, and store this medication out of reach of children.

Serious side effects

• Lactic acidosis
• severe hypoglycemia
• severe allergic reactions
• acute renal failure
• dehydration
• hypotension
• diabetic ketoacidosis
• severe skin reactions
• perineal necrosis
• urosepsis

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, decreased renal creatinine clearance, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, back pain, tendonitis, upper abdominal pain, diarrhea

Store this medication in a tightly closed container to prevent moisture and air ingress. It is important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. This will help maintain the medication's effectiveness.

Appearance

A pink, oval, dual-convex, extended-release film-coated tablet

Package unit

PTP - 30 tablets/box [(6 tablets/PTP) × 5]