Empagliflozin 25 mg Tablet

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If the patient tolerates 10 mg and requires additional blood glucose control, the dose can be increased to 25 mg once daily. It can be taken irrespective of meals, and the tablets should be swallowed whole. If a dose is missed, take it as soon as remembered but do not double the dose on the same day.

This medication should not be administered to certain patients. First, individuals allergic to the active ingredient or any of the excipients should not take this medication. It is also not suitable for patients with type 1 diabetes or diabetic ketoacidosis. Patients with significantly reduced kidney function, with a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m2, those with end-stage renal disease, or patients undergoing dialysis should also not use this medication. Furthermore, since this medication contains lactose, individuals with lactose intolerance, galactose intolerance, or inherited lactase deficiency should not take it. Caution is advised when using this medication in patients with slightly reduced kidney function. In particular, it is advised not to initiate this medication in patients with a GFR of less than 60 mL/min/1.73m2, and if they are currently taking it, the dosage may need to be reduced or discontinued. In patients with end-stage renal disease or those on dialysis, the efficacy of this medication is not expected, thus it should not be used. Patients with heart failure, particularly those with mild to moderate conditions, should use this medication cautiously, and it is not recommended for patients with severe heart failure. When used in combination with insulin or sulfonylureas, there is a risk of hypoglycemia, hence caution is needed and the dosages of these medications may need to be reduced. Possible side effects while taking this medication include hypoglycemia, urinary tract infections, genital infections, increased urination, decreased fluid volume, etc. Particularly, hypoglycemia may occur more frequently when combined with insulin or sulfonylureas, so vigilance is advised. Additionally, rare but serious adverse reactions such as ketoacidosis, pyelonephritis, and perineal necrosis have been reported, so immediate consultation with healthcare professionals is necessary upon the appearance of symptoms. This medication can affect the body’s fluid status, so elderly individuals, those with hypotension, and patients with cardiovascular diseases should be especially cautious. Pregnant women are advised not to take this medication, and it should be discontinued if pregnancy is confirmed. Breastfeeding women should also discontinue breastfeeding while on this medication. Its safety and efficacy have not been established in children under 18 years of age, thus it should not be used in this population. No specific toxic symptoms have been reported in cases of overdose, however, appropriate treatment is necessary depending on clinical conditions. This medication should be kept out of the reach of children, and it should not be transferred to other containers. Caution is required when driving or operating machinery due to the risk of hypoglycemia, especially when taken with insulin or other hypoglycemic agents. When monitoring blood glucose levels while taking this medication, the 1,5-AG test may be unreliable, so other methods are recommended. Finally, regular kidney function tests should be conducted while on this medication, and if symptoms of infection or abnormal signs appear, immediate consultation with healthcare professionals is necessary.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urinary tract sepsis
• pyelonephritis
• perineal necrosis
• severe edema or urinary anomalies
• acute kidney injury
• acute cholecystitis
• autoimmune hepatitis

Mild side effects

Hypoglycemia, vaginal mycotic infection, vulvovaginitis, glans inflammation and other genital infections, increased urination, rash, itching, increased serum lipids, increased serum creatinine, decreased GFR, headache, dizziness, fatigue, peripheral edema, facial edema, weight gain, dry mouth, abdominal distension, cough, chest pain, insomnia, anxiety, vomiting, indigestion, constipation, diarrhea, abdominal pain, back pain, blurred vision, dry eyes, and throat area.

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature.

Appearance

Light yellow, biconvex oval film-coated tablet

Package unit

10 tablets/box (10 tablets/PTP x 1), 30 tablets/box (10 tablets/PTP x 3), 30 tablets/bottle