Dapagliflozin and Metformin Extended-Release Tablets 10/500 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 1 daily dose of dapagliflozin 10 mg / extended-release metformin 2000 mg, with 2 tablets of 5 mg/1000 mg. For those without previous experience in diabetes medication treatment, an initial therapy of 1 tablet once daily of either 5 mg/500 mg or 10 mg/500 mg is recommended. To reduce gastrointestinal side effects of metformin, dosing should be stepwise adjusted.

This medication contains metformin and dapagliflozin and is a diabetes treatment that helps in blood glucose control. It may very rarely cause a serious condition called lactic acidosis; therefore, it should not be used in patients with poor kidney function, severe infection, dehydration, or heart disease. Also, caution is needed when taken alongside other diabetes medications such as insulin or sulfonylureas due to the risk of hypoglycemia. Patients with moderate to severe kidney impairment, acute illness, or those scheduled for surgery should discontinue or use this medication carefully. Women who are pregnant or breastfeeding should not use this medication, and special caution is required for children and the elderly. During the use of this medication, side effects such as dehydration, low blood pressure, genital infections, and urinary infections may occur, so immediate consultation with healthcare personnel is necessary upon occurrence of symptoms. Additionally, vitamin B12 deficiency might occur; therefore, blood tests are recommended for long-term users. This medication should be temporarily stopped before specific tests or surgeries, and excessive alcohol consumption should be avoided during use. In case of overdose, immediate medical attention is required, and dialysis or other measures may be necessary depending on symptoms. Patients should be cautious of symptoms such as dizziness while driving or operating machinery, and keep this medication out of the reach of children.

Serious side effects

• Lactic acidosis
• severe hypoglycemia
• ketoacidosis
• urinary sepsis
• pyelonephritis
• acute kidney injury
• kidney dysfunction
• severe allergic reactions
• severe skin adverse reactions
• severe edema or urinary abnormalities

Mild side effects

Vulvovaginal infections, balanitis and related genital infections, urinary infections, fungal infections, hypoglycemia, decreased fluid volume, dry mouth, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, reduced initial renal creatinine clearance, dyslipidemia, increased blood creatinine, elevated blood urea, weight loss, rash, diarrhea, nausea/vomiting, insomnia

This medication must be stored in a tightly sealed container to protect from air and moisture. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink, double-convex, oval film-coated extended-release tablet

Package unit

30 tablets/bottle, 200 tablets/bottle, 30 tablets/box [(6 tablets/PTP*5)]