Dapagliflozin Extended-Release Tablet 10/500 mg (Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride)

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is one dose of dapagliflozin 10 mg and extended-release metformin 2000 mg, which can be given as two tablets of 5 mg/1000 mg. For patients with no prior experience of diabetes medication, the initial therapy is to administer one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

This medication is used for the treatment of diabetes and should not be used in patients with impaired renal function or acute illnesses. It is not recommended for patients with moderate or worse renal function, and regular renal function tests should be conducted if renal function declines. During treatment, symptoms of decreased fluid volume or hypotension may occur, so caution is necessary, especially for elderly patients or those taking diuretics. When used with insulin or sulfonylurea medications, the risk of hypoglycemia may increase; therefore, dosage adjustments may be necessary. This medication may increase the risk of genital and urinary tract infections, so you should consult a doctor immediately if any infection symptoms appear. There is a rare but serious side effect of lactic acidosis that can occur, so seek immediate treatment if symptoms such as muscle pain, difficulty breathing, or abdominal pain appear. Women who are pregnant or breastfeeding should not use this medication, and those planning to become pregnant should consult a healthcare professional. Excessive alcohol consumption should be avoided while taking this medication; it may be necessary to discontinue it for a certain period prior to surgery or radioiodine imaging. Vitamin B12 deficiency may occur, so regular monitoring of serum vitamin B12 levels is advisable for long-term users. In case of overdose, seek medical attention immediately for proper treatment, and dialysis may be necessary. The safety and efficacy of this medication in children have not been established, and it should be used with caution in elderly patients considering the potential for decreased renal function. Dizziness or symptoms of hypoglycemia may occur during use, so caution is advised when driving or operating machinery. This medication should be stored in its original container and kept out of reach of children.

Serious side effects

Antiphospholipid syndrome, bacterial pneumonia, acute kidney injury, lactic acidosis, diabetic ketoacidosis, urosepsis, pyelonephritis, severe edema, atrial fibrillation, acute cholecystitis, perineal necrosis, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor), severe skin reactions (severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa), respiratory issues (shortness of breath or difficulty breathing)

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, decreased fluid volume, dry mouth, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, increased serum creatinine, dyslipidemia, increased blood urea, weight loss, diarrhea, nausea/vomiting, reduced/deficient vitamin B12, upper abdominal pain, dyspepsia, abdominal discomfort, abdominal pain, dizziness

Store this medication in a tightly sealed container to prevent air or moisture exposure. Additionally, avoid excessively hot or cold places, and it is advisable to store it at room temperature between 1°C and 30°C.

Appearance

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

Package unit

30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]