Dapagliflozin Formate Tablet 5mg

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

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

This drug should not be used in certain patients. For instance, individuals allergic to the components or excipients of this drug, those with Type 1 diabetes, patients with diabetic ketoacidosis, and those genetically predisposed to digest certain sugars should not take this medication. Additionally, it should not be administered to patients undergoing dialysis. Caution should be exercised in patients with fluid volume depletion or kidney function issues. This drug can lower blood pressure or affect kidney function, so hydration status and kidney function should be thoroughly checked before administration, and blood pressure and kidney status should continue to be monitored after taking the medication. During treatment with this drug, adverse effects such as genital infections, urinary tract infections, hypoglycemia, fluid volume depletion, and diabetic ketoacidosis may occur, so immediate consultation with healthcare professionals is recommended if symptoms arise. Particularly, while this drug aids in blood sugar control, its effectiveness may decrease in patients with severely impaired kidney function, so caution is warranted. Women who are pregnant or breastfeeding are advised not to use this medication, and it should be discontinued immediately upon confirmation of pregnancy. Elderly patients or those taking other medications should consult a physician before use, as interactions may occur, particularly with diuretics or insulin, increasing the risk of hypoglycemia or dehydration. There is no special antidote for overdose, so treatment should be based on symptoms and under the guidance of healthcare professionals. Lastly, patients taking this drug should exercise caution when driving or operating machinery and keep it out of reach of children.

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, perineal necrosis, hypoglycemia, volume depletion, thirst, diabetic ketoacidosis, dizziness, constipation, dry mouth, lumbago, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, elevated hematocrit, initial treatment renal creatinine clearance reduction, dyslipidemia, initial treatment serum creatinine elevation, elevated serum urea, weight loss, urosepsis, pyelonephritis, acute kidney injury, renal dysfunction, rash, angioedema, weakness, pain, keratitis, chronic obstructive pulmonary disease, hemoptysis, cerebral hemorrhage, peripheral artery occlusion, angina pectoris, myocardial infarction, biliary stones, cholangitis, alcoholic cirrhosis, depression, suicide attempt, gastric adenocarcinoma, anaphylactic reaction, gastroesophageal reflux disease, upper abdominal pain, diverticulitis, bowel perforation, acute pancreatitis, chronic pancreatitis, paresthesia, cerebral infarction, nerve compression, sensory loss, headache, dyspepsia, nausea, diarrhea, vomiting, urinary retention, urinary abnormalities, increased alanine aminotransferase, increased aspartate aminotransferase, decreased appetite, asthenia, taste disturbance, drowsiness, tension-type headache, carpal tunnel syndrome, diabetic neuropathy, coma, neuralgia, peripheral neuropathy, sleep disorders, syncope, tremors, bronchitis, shingles, sinusitis, tonsillitis, herpes simplex, hordeolum, joint abscess, laryngitis, otitis media, pelvic inflammatory disease, pericoronitis, pneumonia, pulmonary tuberculosis, rhinitis, onychomycosis, herpes simplex, edema, fever, foreign body sensation, facial edema, facial pain, hyperthermia, influenza-like syndrome, chest pain, fatigue, hunger, vaginal discharge, menstrual irregularities, pruritus, urticaria, cold sweat, arthralgia, musculoskeletal pain, limb pain, muscle weakness, myalgia, osteoarthritis, ligament sprain, diabetic retinopathy, cough, dyspnea, orthostatic hypotension, palpitations, insomnia, fatty liver, gallbladder polyp, tinnitus

This medication should be stored in a tightly sealed container to protect it from air and moisture and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and ensure its safe use.

Appearance

Yellow, round film-coated tablet

Package unit

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