Empaglin Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dosage for this medication is 10 mg once daily in monotherapy and additional combination therapy with other hypoglycemic agents such as insulin. If there is good tolerance with the 10 mg dose and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. When used in conjunction with sulfonylureas or insulin, the dosage reduction of those agents may be considered to lessen the risk of hypoglycemia. Administration can be made regardless of meals, and the tablet should be swallowed whole.

This medication should not be used in patients with allergic reactions to the active ingredient or any of the components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication is not to be used in patients with severely impaired kidney function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73 m2 or those with end-stage kidney disease or undergoing dialysis. As this medication contains lactose, it should not be given to patients with genetic issues such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption. In patients with decreased kidney function, this medication should be given with caution, and it is important to regularly monitor kidney function before and during administration. In patients with mild to moderate heart failure, it should be used cautiously, and it is not recommended for patients with severe heart failure. This medication may increase the risk of hypoglycemia when used in conjunction with insulin or sulfonylureas, so dosage adjustments of the hypoglycemics may be necessary when used together. While taking this medication, side effects such as hypoglycemia, infections, increased urination, urinary tract infections, and decreased fluid volume may occur, and any unusual symptoms should be promptly discussed with healthcare personnel. Especially, even if blood sugar is within the normal range, ketoacidosis may occur; symptoms such as nausea, vomiting, abdominal pain, and breathing difficulties require immediate testing and treatment. Elderly patients aged 75 and older are at greater risk of fluid loss; therefore, caution is required when using this medication, and its use in patients aged 85 and older is not recommended. This medication carries a risk of dehydration or hypotension, so it should be used cautiously in patients with low blood pressure or cardiovascular diseases. There may be an increased risk of urinary infections and genital fungal infections, so prompt treatment is required if symptoms of infection occur. Taking this medication may result in a positive glucose test in urine, which needs to be taken into account. Care should be taken when driving or operating machinery, especially in case of hypoglycemia risk. There may be possible interactions with other medications; inform healthcare professionals of any medications being taken. Women who are pregnant or planning to become pregnant are advised against using this medication, and breastfeeding women should discontinue breastfeeding if taking this medication. The safety and effectiveness of this medication have not been established in children or adolescents. In the case of overdose, no specific toxic symptoms have been reported; however, appropriate treatment based on clinical condition may be necessary. This medication should be stored out of reach of children, and it is safe not to transfer it to another container.

Serious side effects

Hives, angioedema, ketoacidosis, rash, necrotizing fasciitis, urosepsis, pyelonephritis, severe allergic reactions, severe skin reactions, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, significantly reduced urine output, severe generalized swelling with elevated blood pressure

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• balanitis
• genital infections
• increased urination
• urinary tract infections
• loss of fluid volume
• increased serum creatinine
• decreased glomerular filtration rate
• fever

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1°C and 30°C.

Appearance

Pale yellow, biconvex round film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 30 tablets/box [(10 tablets/PTP x 3)], 30 tablets/bottle