Zadium Tablet 25 mg (Empagliflozin)

Adult dose

The recommended dosage of this medication is one 10 mg tablet once daily as monotherapy and in combination with other glucose-lowering drugs such as insulin. If the 10 mg dosage has excellent tolerance and additional blood sugar control is needed, the dosage can be increased to 25 mg once daily. When co-administering this medication with sulfonylureas or insulin, consider reducing the dose of sulfonylureas or insulin to decrease the risk of hypoglycemia.

This medication should not be used in patients who have had allergic reactions to the active ingredients or components. This medication is not suitable for patients with type 1 diabetes or diabetic ketoacidosis. It is contraindicated in patients with severely reduced kidney function, that is, with a glomerular filtration rate (GFR) below 30 mL/min/1.73 m², end-stage renal disease, or those undergoing dialysis. Since it contains lactose, it should not be used in patients with lactose intolerance, galactose intolerance, or genetic lactase deficiency. In patients with reduced kidney function, this medication should be used with caution, and treatment initiation should be avoided if the GFR is below 60 mL/min/1.73 m². If kidney function drops below 45 mL/min/1.73 m² during treatment, it is necessary to discontinue the medication. In patients with heart failure, especially those with mild to moderate cases, it should be used with caution, and it is not recommended for severe heart failure patients. There may be an increased risk of hypoglycemia when co-administered with insulin or sulfonylureas; thus, dose adjustments may be necessary. The most common side effect during use is hypoglycemia, particularly when used with insulin or sulfonylureas, so caution is warranted. Symptoms such as genital infections, urinary tract infections, increased urination, dehydration, and hypotension may occur, so consult a healthcare professional immediately if these symptoms arise. Rarely, serious metabolic disruptions such as ketoacidosis may occur, and immediate testing is required if symptoms like nausea, vomiting, abdominal pain, or respiratory distress appear. Use during pregnancy is not recommended, and the medication should be discontinued if pregnancy is confirmed. If breastfeeding, it is advisable to stop breastfeeding as this medication may be excreted in breast milk. Safety and effectiveness have not been established for children under 18 years of age. While no specific toxicity symptoms have been reported in case of overdose, appropriate treatment may be required depending on clinical conditions. This medication should be kept out of reach of children, and transferring to other containers should be avoided. There is a risk of hypoglycemia when driving or operating machinery, so caution is advised, especially when used with insulin or sulfonylureas. Regular kidney function tests should be performed during the course of treatment, and if symptoms of urinary tract or genital infections occur, notify a healthcare professional immediately.

Serious side effects

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

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balinitis
• and other genital infections
• increased urination
• urinary tract infections
• volume depletion
• increased serum creatinine
• decreased glomerular filtration rate

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius. Following these instructions helps safely maintain the effectiveness of the medication.

Appearance

Pale yellow oval film-coated tablets

Package unit

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