Empagliflozin 10mg Tablets

Adult dose

The recommended dosage of this medication is 10 mg once daily as monotherapy and in combination therapy with other hypoglycemic agents like insulin. If additional blood sugar control is required and tolerance is good, the dosage may be increased to 25 mg once daily. It can be administered regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, and do not take double the dose in a single day.

This medication should not be used in patients who have an allergic reaction to the active ingredient or any of the components. Additionally, it should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, end-stage kidney disease, or those undergoing dialysis should also avoid using this medication. As this medication contains lactose, it should not be given to patients with genetic metabolic disorders such as lactose intolerance or galactose intolerance. In patients with slightly reduced kidney function, it should be administered with caution, and regular monitoring of kidney function before and during administration is important. In patients with heart failure classified as NYHA stage I~II, it should be used cautiously, while it is not recommended for patients in stages III~IV. When used in combination with insulin or insulin secretagogues, there is a risk of hypoglycemia, necessitating dosage adjustments of those medications. While taking this drug, side effects such as hypoglycemia, vulvovaginitis, genital infections, increased urination, urinary tract infections, and fluid volume depletion may occur, so patients should monitor for symptoms. Particularly, elderly patients or those at risk of fluid loss should be cautious of dehydration or hypotension, and it is advisable to regularly observe fluid status. Serious metabolic abnormalities such as ketoacidosis may occur, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing develop, immediate consultation with a healthcare professional is necessary. Rare but serious infections such as Fournier's gangrene have also been reported; immediate treatment should be sought if there is pain, swelling, or redness around the perineum or genitals. It is recommended to discontinue the use of this medication if pregnancy occurs or is confirmed, and it should also be avoided during breastfeeding. This medication is not used in children under 18 years old as safety and efficacy have not been established. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is required depending on the clinical condition. This medication should be kept out of reach of children, and it should not be transferred to other containers. Caution should be exercised while driving or operating machinery, especially when used in combination with insulin or sulfonylureas due to the risk of hypoglycemia. This medication has low interaction potential with other drugs; however, caution is advised when used in conjunction with some diuretics or insulin secretagogues. Diabetic patients should also pay attention to daily foot care and infection prevention while taking this medication.

Serious side effects

• Urticaria
• angioedema (severe swelling)
• ketoacidosis
• Fournier's gangrene
• uroseptic shock and pyelonephritis
• rash
• angioedema
• chest tightness
• difficulty breathing
• asthma attacks

Mild side effects

Hypoglycemia, vulvovaginitis, balanitis and other genital infections, increased urination (including frequent urination, polyuria, or nocturia), urinary tract infections, fluid volume depletion (decreased blood pressure, dehydration, hypotension, etc.), increased serum creatinine, decreased glomerular filtration rate, rash, itching, urticaria, angioedema, difficulty urinating, interstitial nephritis, thirst, increased serum lipids, increased hematocrit, lumbago, glaucoma, etc.

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. Additionally, it is best stored at room temperature between 1°C and 30°C.

Appearance

Light 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