Empagliflozin 10 mg Tablet (Empagliflozin)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and as an adjunct therapy with insulin and other antihyperglycemic agents. If you have excellent tolerance and require additional blood sugar control, the dosage can be increased to 25 mg once daily. When used in conjunction with sulfonylureas or insulin, dosage reduction of these may be considered to reduce the risk of hypoglycemia. This medication can be taken regardless of meals, and the tablet should be swallowed whole.

This medication should not be administered to certain patients. First, it should not be used by individuals who are allergic to the active substance or other ingredients in this medication. Moreover, this medication should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, specifically with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2 or end-stage renal disease, or those undergoing dialysis, are also not suitable candidates for this medication. This medication contains lactose, so it should not be taken by patients with lactose intolerance or galactose metabolism disorders. Caution is required when using this medication in patients with mild renal impairment. In particular, it is not recommended to initiate treatment in patients with an eGFR of less than 60 mL/min/1.73m2, and kidney function should be regularly monitored during treatment. If kidney function deteriorates further and falls below an eGFR of 45 mL/min/1.73m2, this medication should be discontinued. The effectiveness of this medication is not expected in patients with end-stage renal disease or those undergoing dialysis. In patients with heart failure, especially those with severe heart failure, data on the safety and efficacy of this medication is limited, and caution is advised. There may be an increased risk of hypoglycemia when this medication is used in conjunction with insulin or sulfonylureas, so dosage adjustments of those medications may be necessary. Various adverse reactions may occur when taking this medication. The most common side effect is hypoglycemia, especially when used alongside insulin or sulfonylureas, which increases the hypoglycemia risk. Genital infections such as vulvovaginitis, balanitis, and other genital infections may also occur. Increased urination frequency, urinary tract infections, and reduced fluid volume (dehydration, hypotension, etc.) have also been reported. Severe metabolic abnormalities such as ketoacidosis may occur in relation to this medication, and ketoacidosis can manifest even when blood sugar levels are not markedly elevated, so caution is necessary. If symptoms of ketoacidosis are suspected, consult a doctor immediately and discontinue treatment. In elderly patients, especially those over 75 years of age, the risk of fluid volume loss is higher, so it is essential to closely monitor fluid status and blood pressure when this medication is administered. This medication can affect kidney function, so regular kidney function assessments should be performed before and during treatment. There may be an increased risk of genital fungal infections while taking this medication, so treatment should be initiated promptly if symptoms arise. Caution is required when driving or operating machinery due to the risk of hypoglycemia, especially when used in conjunction with insulin or sulfonylureas. The use of this medication is not recommended during pregnancy, and it should be discontinued if pregnancy is confirmed. In the case of breastfeeding, it is advisable to stop breastfeeding, as this medication may be secreted in breast milk. The safety and efficacy of this medication have not been established in children under 18 years of age, and usage in this population is not recommended. No specific toxic symptoms have been reported in cases of overdose; however, appropriate treatment should be given based on clinical conditions in case of overdose. Finally, this medication should be kept out of reach of children and should not be transferred to other containers.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urosepsis
• pyelonephritis
• necrotizing fasciitis

Mild side effects

• Itching
• rash
• hypoglycemia
• vulvovaginitis
• balanitis and other genital infections
• increased urination
• urinary hesitancy
• interstitial nephritis
• thirst
• increased serum lipids

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. Additionally, it is important to keep the medication at room temperature, between 1 to 30 degrees Celsius, to maintain its effectiveness.

Appearance

Pale yellow, round film-coated tablet

Package unit

PTP - 30 tablets/PTP [10 tablets/PTP x 3], PTP - 10 tablets/PTP [10 tablets/PTP x 1]