Empagliflozin 10 mg Tablet

Adult dose

The recommended dose of this drug is 10 mg once daily as monotherapy and in combination with insulin or other hypoglycemic agents. If the patient shows good tolerance of 10 mg and additional blood glucose control is needed, the dose may be increased to 25 mg once daily. This drug can be administered regardless of meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

This drug should not be used in patients with allergy to the active ingredient or components. It should not be administered to patients with type 1 diabetes or severe diabetic ketoacidosis. It is not to be used in patients with severely impaired kidney function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73m2 or those with end-stage renal disease or on dialysis. This drug contains lactose and should not be administered to patients with genetic metabolic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Caution is advised in patients with mildly impaired kidney function, particularly those with a glomerular filtration rate of less than 60 mL/min/1.73m2, where initiation of treatment should be avoided and dose adjustment or discontinuation considered if already under treatment. In patients with heart failure of mild to moderate degree, caution is required; it is not recommended for those with severe heart failure. When used with insulin or sulfonylureas, there is a risk of hypoglycemia, so it may be necessary to adjust the doses of these medications. This drug can induce side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, and volume depletion, thus patients should seek medical advice immediately if symptoms develop. Particularly, serious metabolic disturbances like ketoacidosis can occur, and if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing arise, prompt evaluation and treatment is necessary. Elderly patients and those at high risk of volume depletion should be careful of dehydration and hypotension, with regular checks of fluid status recommended. This drug may affect kidney function, so renal function tests should be performed regularly before and during treatment. Women who are pregnant or planning to become pregnant are advised not to use this drug, and breastfeeding mothers should suspend nursing. Safety and efficacy in children under 18 years have not been established, thus use is not recommended. No specific toxic reactions have been reported in the case of overdose, but appropriate care may be needed depending on the clinical situation. This drug may interact with other medications, so it is essential to inform healthcare providers of all other medicines being taken. Caution is advised when driving or operating machinery due to the risk of hypoglycemia. While on this medication, regular consultations with healthcare providers and immediate reporting of any unusual symptoms are necessary.

Serious side effects

Urticaria, angioedema, necrotizing fasciitis, ketoacidosis, urosepsis, pyelonephritis, severe allergic reactions, severe skin adverse reactions, severe edema or urination abnormalities, liver dysfunction (jaundice), severe neurological symptoms, respiratory problems, necrotizing fasciitis (Fournier's gangrene)

Mild side effects

• Hypoglycemia
• vulvar candidiasis
• vulvitis
• balanitis
• and other genital infections
• increased urination
• urinary tract infections
• volume depletion
• increased serum creatinine
• decreased glomerular filtration rate

This drug may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Doing so will help preserve the drug's efficacy and safety over time.

Appearance

Light yellow, round, biconvex film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP X1], 30 tablets/box [10 tablets/PTP X3], 30 tablets/bottle