Neo Empag 10 mg (Empagliflozin)

Adult dose

The recommended dosage for this medication for monotherapy and additional combination therapy with other hypoglycemic agents such as insulin is 10 mg once daily. If good tolerability is observed and additional blood sugar control is needed, the dosage may be increased to 25 mg once daily. It can be administered without regard to meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses on the same day.

This medication should not be used by individuals who have allergic reactions to the main component or other ingredients of this medication. This medication should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication should not 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 patients receiving dialysis due to end-stage renal disease. Additionally, this medication contains lactose, therefore it should not be administered to patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Caution is advised when using this medication in patients with mildly impaired kidney function, and it is not recommended to start treatment in patients with a glomerular filtration rate of less than 60 mL/min/1.73m². If kidney function deteriorates to below 45 mL/min/1.73m², the use of this medication should be discontinued. In patients with heart failure, especially those with mild to moderate cases, caution is required; it is not recommended for patients with severe heart failure. When used in conjunction with medications that can cause hypoglycemia, such as insulin or sulfonylureas, dose adjustments may be necessary due to the risk of hypoglycemia. While taking this medication, side effects such as hypoglycemia, genital infections, increased urination, urinary tract infections, decreased fluid volume, increased serum creatinine, etc., may occur, so caution is advised. Severe metabolic acidosis, known as ketoacidosis, can occur rarely, so if symptoms such as vomiting, abdominal pain, or shortness of breath arise, immediate consultation with healthcare professionals is necessary. Moreover, elderly patients or those at risk of fluid loss should be cautious of dehydration and hypotension, and discontinuation of this medication may be necessary as needed. This medication can increase the risk of urinary tract infections and genital fungal infections, so it is essential to promptly treat any signs of infection. Caution is required when driving or operating machinery due to the risk of hypoglycemia. Women who are pregnant or planning to become pregnant should avoid using this medication, and those who are breastfeeding are advised to discontinue breastfeeding during treatment. The safety and efficacy of this medication in pediatric patients under 18 years of age have not been confirmed. Although no specific toxic symptoms have been reported in cases of overdose, appropriate treatment is required based on the patient’s condition. Finally, this medication should be stored out of reach of children and should not be transferred to other containers for safety.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urosepsis and pyelonephritis
• perineal necrosis

Mild side effects

• Hypoglycemia
• itching
• rash
• vulvovaginitis
• balanitis
• increased urination
• urination difficulties
• interstitial nephritis
• thirst
• increased serum lipids

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

Appearance

Pale yellow round film-coated tablets

Package unit

PTP - 30 tablets/PTP [(10 tablets/PTP X 3)], PTP - 10 tablets/PTP [(10 tablets/PTP X 1)]