Zepajinjung 10 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and adjunct therapy with insulin or other hypoglycemic agents. If this dosage of 10 mg is well-tolerated and further blood glucose control is necessary, the dosage can 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 exceeding double the recommended daily dose. Special Population: Patients with Renal Impairment: No dosage adjustments are necessary for mild renal impairment. Treatment should not be initiated in patients with glomerular filtration rates (eGFR) below 60 ml/min/1.73m2 [or CrCl < 60 ml/min]. Patients with well-tolerated administration of this medication and a constantly reduced glomerular filtration rate below 60 ml/min/1.73m2 [or CrCl < 60 ml/min] should adjust or maintain the dosage of this medication to 10 mg once daily. If the glomerular filtration rate decreases to below 45 ml/min/1.73m2 [or CrCl < 45 ml/min], this medication should be discontinued. It is not used in patients with end-stage renal disease (ESRD) or those undergoing dialysis as its efficacy is not expected. Patients with Hepatic Impairment: No dosage adjustments are necessary for mild to moderate hepatic impairment. Its use is not recommended in patients with severe hepatic impairment as it has not been studied in this population. Patients of Advanced Age: No dosage adjustments are necessary based on age. Patients over 75 years of age should consider the risks of kidney function impairment and fluid volume depletion. As clinical experience in elderly patients over 85 years is limited, initiating treatment in this age group is not recommended.

This medication should not be used in certain patients. Patients with allergies to the active ingredient or ingredients in this medication, patients with type 1 diabetes or diabetic ketoacidosis, patients with severely impaired kidney function or end-stage kidney disease, and patients with genetic disorders affecting lactose breakdown should not be administered this medication. Patients with slightly reduced kidney function should use this medication with caution, and treatment should be discontinued if kidney function worsens. Additionally, its use is not recommended in patients with severe heart failure. When co-administered with insulin or insulin secretagogues, there may be a risk of hypoglycemia, requiring dosage adjustments. This medication may have various side effects, the most common being hypoglycemia, which may occur more frequently when taken with insulin or sulfonylureas. Other reported side effects include genital infections, urinary tract infections, increased urination, dehydration, low blood pressure, liver function abnormalities, etc. Particularly, serious metabolic abnormalities such as ketoacidosis may occur, so if symptoms like vomiting, abdominal pain, or difficulty breathing arise, it is important to consult a doctor immediately. Elderly patients or those at risk of fluid loss should be cautious of dehydration and low blood pressure, and it is essential to regularly monitor kidney function and fluid status. This medication requires caution when driving or operating machinery due to the risk of hypoglycemia, and if pain or swelling develops in the genital or perineal area, serious infection should be suspected, and immediate treatment is required. Pregnant or nursing women are advised to avoid using this medication, and it should be discontinued if pregnancy is confirmed. It is not used in children as the safety and efficacy of this medication have not been established. No specific toxic symptoms have been reported in cases of overdose, but if symptoms appear, immediate medical attention should be sought. This medication should be kept out of the reach of children, and it is advisable to avoid transferring it to other containers.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• ketoacidosis
• urinary sepsis
• and pyelonephritis

Mild side effects

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

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

Appearance

Pale yellow, double-convex, round film-coated tablet

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle