Empa Tablets 25 mg (Empagliflozin)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other glucose-lowering agents. If the 10 mg dose is well-tolerated and additional blood glucose control is required, the dose may be increased to 25 mg once daily. This medication can be taken without regard to meals. Tablets should be swallowed whole. Do not double the dose on the same day.

This medication should not be used in certain patients. For example, individuals with allergic reactions to the active ingredient or components of this medication should not take it. Additionally, it is not to be used in patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m² or those undergoing dialysis for end-stage renal disease, should also avoid this medication. This medication contains lactose, so individuals with genetic conditions such as lactose intolerance or galactose intolerance should also refrain from taking it. In patients with some degree of kidney impairment, the medication should be administered cautiously. Treatment should not commence if the glomerular filtration rate is below 60 mL/min/1.73m² at the start of therapy, and dosing adjustments or discontinuation should be made if kidney function continues to decline during treatment. This medication is not expected to be effective in patients with end-stage renal disease or those undergoing dialysis. Regular kidney function tests prior to and during treatment are recommended, as this medication can affect kidney function. In patients with heart failure, particularly those with mild to moderate cases, caution should be exercised in usage, and it is not recommended for patients with severe heart failure. When used in conjunction with drugs like insulin or sulfonylureas, there may be an increased risk of hypoglycemia, and dose adjustments for those medications may be necessary. Various adverse reactions may occur while using this medication. The most common side effect is hypoglycemia, particularly when used in combination with insulin or sulfonylureas, increasing the risk. Genital infections, urinary tract infections, and symptoms of increased urination are also frequently reported. Symptoms of dehydration or hypotension due to decreased circulating volume may arise, necessitating caution especially in elderly patients or those with cardiovascular disease. Rarely, serious side effects such as ketoacidosis, liver damage, and perineal necrosis have been reported, so if symptoms occur, immediate consultation with medical personnel is required. This medication increases glucose excretion in the body, aiding in blood sugar control; however, this may lead to increased urination and electrolyte imbalances. Therefore, it is important to periodically check fluid status and consider temporarily halting treatment in cases of significant fluid loss. Furthermore, glucose may be detected in urine tests while taking this medication. The safety of this medication has not been completely established during pregnancy, so it is advisable to avoid use during this time, and treatment should be discontinued upon confirmation of pregnancy. When breastfeeding, it is recommended to discontinue nursing, as this medication may potentially pass into breast milk. This medication is not used in children under 18 years of age, as its safety and effectiveness have not been established. No specific toxic symptoms have been reported in cases of overdose; however, appropriate treatment may be required based on the patient's condition. This medication should be stored out of reach of children, and transferring it to another container is not advisable as it may affect quality. Lastly, this medication may interact with other drugs, so particularly when taking diuretics or insulin medications, it may be necessary to consult a physician or pharmacist for dose adjustments. Caution should also be exercised when driving or operating machinery, considering the risk of hypoglycemia.

Serious side effects

• Hives
• severe swelling (angioedema)
• ketoacidosis
• urosepsis
• pyelonephritis
• angioedema
• perineal necrosis
• acute kidney injury
• deep vein thrombosis
• perineal necrosis

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• genital infections
• increased urination
• rash
• itching
• dehydration
• hypotension
• decreased blood volume

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1°C and 30°C, which helps maintain the drug's efficacy and safety.

Appearance

Pale 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