Budian Tablets 10 mg (Empagliflozin)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and for additional combination therapy with other blood glucose-lowering agents such as insulin. If excellent tolerance is observed and additional blood sugar control is required, the dosage may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but not double the dosage in one day.

This drug should not be used in patients with hypersensitivity to the active ingredient or any of the components. It should not be given to patients with type 1 diabetes or diabetic ketoacidosis. It should not be used in patients with severely impaired renal function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m2, end-stage renal disease, or those undergoing dialysis. This drug contains lactose and should not be administered to patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndromes. In patients with renal impairment, it should be used cautiously, and treatment should be avoided in those with a glomerular filtration rate below 60 mL/min/1.73m². If there is continued decline in renal function during treatment, dose adjustment or discontinuation may be necessary. Experience with this medication is limited in patients with heart failure, particularly those with severe heart failure, so it should be used cautiously and is not recommended in severe cases. When used in conjunction with insulin or sulfonylureas, the risk of hypoglycemia may increase, necessitating dose adjustments of these medications. While using this medication, monitoring for adverse reactions such as hypoglycemia, infections, particularly genital and urinary tract infections, increased urination, decreased fluid volume, is important. Serious metabolic abnormalities known as ketoacidosis may occur, thus if related symptoms (nausea, vomiting, abdominal pain, dyspnea, etc.) arise, consult with a healthcare professional immediately. In elderly patients, particularly those over 75 years of age, there is an increased risk of fluid volume loss, and caution is advised. Severe urinary infections such as urosepsis and pyelonephritis have been reported, and rapid evaluation and treatment are necessary if infection symptoms are present. There is an increased risk of genital fungal infections, and appropriate treatment is necessary if related symptoms occur. While taking this medication, a positive urine glucose test may occur. Caution is required when driving or operating machinery due to the risk of hypoglycemia. Administration of this drug during pregnancy is not recommended, and it should be discontinued if pregnancy is confirmed. For nursing mothers, since this drug may be excreted in breast milk, cessation of breastfeeding is advisable. Safety and effectiveness in children under 18 have not been established, and therefore it should not be used in this age group. No specific toxic symptoms have been reported in the event of overdose; however, appropriate treatment based on the clinical condition is needed. This drug should be kept out of reach of children, and transferring it to another container is not advisable as it may affect quality.

Serious side effects

• Rash
• angioedema
• ketoacidosis
• urosepsis
• pyelonephritis
• necrotizing fasciitis

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis and other genital infections
• increased urination
• difficulty urinating
• rash
• itching
• increased serum lipids
• increased serum creatinine
• decreased glomerular filtration rate

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is safest to store the medication at room temperature between 1°C and 30°C, avoiding extremely hot or cold environments.

Appearance

Light yellow round film-coated tablets

Package unit

PTP - 30 tablets/PTP [10 tablets/PTP x 3]