Dapagliflozin Formate 10mg Tablet

Adult dose

Type 2 diabetes mellitus Monotherapy and add-on combination therapy The recommended dose of this medicine is 10mg once daily for monotherapy and add-on combination therapy with other glucose-lowering agents, including insulin. When this medicine is used in combination with insulin or an insulin secretagogue such as a sulfonylurea, a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia. Initial combination therapy For patients with no previous experience of treatment with diabetes medications, when this medicine is administered in combination with metformin, the recommended initial dose is 5mg once daily or 10mg once daily. Chronic heart failure and chronic kidney disease The recommended dose of this medicine is 10 mg once daily. Special populations Renal impairment - eGFR less than 45 mL/min/1.73m2: Use of this medicine to improve glycemic control is not recommended. - eGFR less than 25 mL/min/1.73m2: Initiation of this medicine is not recommended in patients with chronic heart failure and chronic kidney disease. - Patients on dialysis: Do not administer this medicine. Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment. For patients with severe hepatic impairment, 5 mg is recommended as the starting dose. If well tolerated, this dose may be increased to 10mg. Elderly (≥ 65 years) Dosage adjustment based on age is not recommended. Method of administration This medicine may be administered orally once daily at any time of day, with or without food. Swallow the tablet whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. No relevant data are available.

This medication should not be administered to patients who are allergic to its active ingredient or excipients. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis. This medication contains anhydrous lactose, which may pose risk for patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It should not be used in patients undergoing dialysis. Caution should be exercised in patients with fluid volume depletion or impaired kidney function, as this medication may cause hypotension and deterioration of renal function; therefore, fluid status and renal function should be closely monitored before and during use. In patients with moderate to severe renal impairment, the blood sugar control effect of this medication may be reduced. The use of this medication may increase the risk of infections such as genital infections and urinary tract infections, so immediate treatment is required if infection symptoms occur. Due to the risk of hypoglycemia, dose adjustments may be necessary when used in conjunction with hypoglycemic agents such as insulin or sulfonylureas. Withdrawal of the medication may be necessary during dehydration symptoms induced by reduced fluid volume or hypotension until recovery occurs. Rarely, life-threatening infections such as serious perineal necrosis (Fournier's gangrene) may occur, so if symptoms like pain, swelling, and redness around the genital region appear, immediate medical attention is required. It is advisable to avoid using this medication during pregnancy, and it should be stopped immediately if pregnancy is confirmed. Breastfeeding women should also avoid using this medication, as safety has not been established. Safety and efficacy in children have not been adequately established, with insufficient related data. In case of overdose, as there is no specific antidote, appropriate treatment should be provided according to the symptoms, consulting a physician if necessary. This medication does not significantly affect driving or machine operation, but caution should be taken regarding hypoglycemic symptoms when used with insulin and other agents. This medication should be stored out of reach of children, and it is safer to keep it in its original container.

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, perineal necrosis, hypoglycemia, decreased fluid volume, thirst, diabetic ketoacidosis, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, elevated hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, elevated blood creatinine at the beginning of treatment, elevated blood urea, weight loss, urosepsis, pyelonephritis, acute kidney injury, renal dysfunction, rash, angioedema, asthenia, pain, ligament sprain, keratitis, chronic obstructive pulmonary disease, hemoptysis, cerebral hemorrhage, peripheral artery occlusion, angina, myocardial infarction, biliary stones, cholangitis, alcoholic liver cirrhosis, depression, suicide attempt, gastric adenocarcinoma, anaphylactic reaction, sensory disturbances, cerebral infarction, nerve compression, dyspepsia, nausea, diarrhea, vomiting, urinary retention, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased appetite, somnolence, headache, nasopharyngitis, upper respiratory infection, chest pain, fatigue, chest discomfort, peripheral edema, generalized edema, hunger, vaginal discharge, menstrual irregularities, itching, urticaria, cold sweat, arthralgia, musculoskeletal pain, limb pain, muscle weakness, myalgia, osteoarthritis, diabetic retinopathy, cough, dyspnea, orthostatic hypotension, palpitations, insomnia, fatty liver, gallbladder polyp, tinnitus

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way helps to maintain its efficacy and ensure safe use.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP X 3)]