Empagliflozin 25 mg Tablets

Adult dose

The recommended dosage of this medication for monotherapy and additional combination therapy with other hypoglycemic agents such as insulin is 10 mg once daily. If the patient tolerates the 10 mg dosage well but requires additional blood glucose control, the dosage may be increased to 25 mg once daily. When this medication is co-administered with sulfonylureas or insulin, dosage reduction of sulfonylureas or insulin may be considered to decrease the risk of hypoglycemia.

This medication should not be administered to certain patients. First, it should not be used if the patient is allergic to any components of this medication. Additionally, it should not be taken by patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired renal function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73m2 or those undergoing dialysis due to end-stage kidney disease should not use this medication. Since this medication contains lactose, patients with lactose intolerance or hereditary lactose metabolism disorders should not be administered this medication. Cautious use is required for patients with slightly impaired renal function. Patients with a glomerular filtration rate of less than 60 mL/min/1.73m2 should not use this medication from the start, and those currently receiving it may need to reduce their dosage or discontinue it. There is no expected effect in patients with end-stage renal disease or those undergoing dialysis. Patients with heart failure, particularly those with mild to moderate severity, should use this medication with caution, while it is not recommended for those with severe heart failure. Taking this medication alongside insulin or sulfonylureas may increase the risk of hypoglycemia, so a reduction in the dosage of insulin or those agents may be necessary. Patients should be vigilant for adverse reactions while taking this medication. The most common adverse reaction is hypoglycemia, which occurs more frequently when used in combination with insulin or sulfonylureas. Symptoms such as genital infections, urinary tract infections, and increased urination may arise; in such cases, patients should consult their doctor. Dehydration or hypotension due to decreased fluid volume may also occur, so elderly patients or those with low blood pressure should exercise caution. This medication may rarely cause severe infections like necrotizing fasciitis, so immediate treatment is required if related symptoms (such as pain, swelling, and redness) arise. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, the medication should be discontinued. Children under 18 years have not established safety and efficacy for this medication, thus it should not be administered to them. There have been no reports of specific toxic reactions with overdose, but appropriate therapeutic measures are necessary according to the clinical condition. This medication should be kept out of reach of children and should not be transferred to other containers. Due to the risk of hypoglycemia, caution should be taken when driving or operating machinery. While monitoring blood glucose control, this medication may affect the results of the 1,5-AG test, so it is better to use other methods.

Serious side effects

Urticaria, angioedema, ketoacidosis (including diabetic ketoacidosis), urosepsis and pyelonephritis, rash, necrotizing fasciitis, liver abnormalities (liver damage and autoimmune hepatitis), deep vein thrombosis, acute kidney injury, acute cholecystitis, cholelithiasis, vascular stent stenosis, vascular stent thrombosis, acute cholecystitis, autoimmune hepatitis, pyelonephritis, sepsis, necrotizing fasciitis, angina pectoris, Prinzmetal angina, unstable angina,

Mild side effects

Hypoglycemia, vulvovaginal candidiasis, balanitis and other genital infections, increased urination (including frequent urination, polyuria, nocturia), rash, urticaria, angioedema, decreased fluid volume, increased serum lipids, elevated serum creatinine, reduced glomerular filtration rate, interstitial nephritis, thirst, fatigue, peripheral edema and swelling, headache, dizziness, facial paralysis, drowsiness, weight gain and loss, anxiety, insomnia, constipation, diarrhea,

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

Light yellow, oval-shaped, film-coated tablets with a biconvex surface

Package unit

10 tablets/box [10 tablets/PTP*1], 30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle