Empa Tablet 25 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with other antihyperglycemic agents such as insulin. If this medication at 10 mg is well tolerated and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered without taking double the dose on the same day.

This medication should not be administered to patients with allergies to the active ingredient or components. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis. It should not be administered to patients with severely impaired renal function, end-stage renal disease, or those on dialysis. This medication contains lactose, so it should not be used in patients with lactose intolerance or related genetic disorders. Caution should be exercised when administering to patients with reduced kidney function, and dose adjustment or discontinuation may be required based on glomerular filtration rate. Caution should be used in patients with heart failure NYHA class I-II, and it is not recommended for patients NYHA class III-IV. When used in combination with insulin or sulfonylureas, there is an increased risk of hypoglycemia, and adjustments to the doses of these medications may be necessary. Adverse reactions such as hypoglycemia, genital infections, urinary tract infections, increased urination, and reduced fluid volume may occur. In particular, severe ketoacidosis may occur, and if symptoms arise, treatment should be immediately stopped and medical consultation sought. Elderly patients or those at risk of fluid volume loss should be monitored for dehydration or hypotension, and regular kidney function tests are necessary. Severe urinary infections, such as urosepsis and pyelonephritis, have been reported, so prompt evaluation and treatment are needed if infection symptoms occur. Genital fungal infections may occur frequently, so appropriate treatment is necessary if related symptoms arise. During the use of this medication, urine tests may show positive glucose results. Care should be taken while driving or operating machinery, especially when used in combination with insulin or sulfonylureas due to the risk of hypoglycemia. An increased risk of foot amputation has been reported, so foot care should be prioritized. Severe infections such as necrotizing fasciitis may occur rarely, and immediate medical attention should be sought if pain or swelling occurs in the affected area. This medication may interact with other drugs, so inform your healthcare provider if you are taking any other medications. Pregnant women or those planning to conceive are advised not to use this medication, and breastfeeding women should discontinue nursing while using this medication. Safety and effectiveness have not been established in children under 18 years of age, so it should not be used in this population. No specific toxic symptoms have been reported in case of overdose, but appropriate treatment may be required based on clinical condition. This medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Serious side effects

• Urticaria
• angioedema
• ketoacidosis
• necrotizing fasciitis
• urosepsis
• and pyelonephritis
• severe edema or urination abnormalities
• severe allergic reactions
• severe skin reactions

Mild side effects

• Hypoglycemia
• itching
• rash
• increased urination
• reduced fluid volume
• increased serum lipids
• elevated serum creatinine
• decreased glomerular filtration rate
• dermal cysts
• seborrheic dermatitis

This medication may be sensitive to air or humidity, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature to safely preserve the drug's effectiveness for a long time.

Appearance

Light yellow, bilaterally convex, oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP×1)], 30 tablets/box [(10 tablets/PTP×3)], 30 tablets/bottle