Zardiempa Tablet 25 mg (Empagliflozin)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and as an add-on to other antihyperglycemic agents like insulin. If tolerability is good on 10 mg and additional blood sugar control is needed, the dosage may be increased to 25 mg once daily. When this medication is co-administered with sulfonylureas or insulin, a reduction in the dose of sulfonylureas or insulin may be considered to reduce the risk of hypoglycemia.

This medication should not be used in patients with known allergies to specific components. It may be dangerous when administered to patients with type 1 diabetes or diabetic ketoacidosis. It is not suitable for patients with severely impaired renal function or those undergoing dialysis. Patients with genetic metabolic disorders such as lactose intolerance or galactose intolerance should also not use this medication. For patients with slightly impaired renal function, dose adjustment is necessary, and it should be discontinued in cases of severe renal impairment. For patients with severe heart failure, the use of this medication is not recommended. Caution should be exercised if taken together with insulin or sulfonylureas due to the risk of hypoglycemia. This medication may cause side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, dehydration, and low blood pressure. Older patients are at increased risk of side effects due to fluid loss and should be monitored closely. A severe metabolic disturbance known as ketoacidosis may occur, so immediate consultation with healthcare professionals is needed if symptoms appear. Cases of liver damage have been reported, so patients with liver dysfunction should be cautious. This medication should be used cautiously in patients at risk of dehydration or low blood pressure, and fluid status should be monitored regularly. There is a risk of serious urinary tract infections such as urosepsis and pyelonephritis, so infection symptoms should be monitored carefully. There is an increased risk of genital fungal infections; treatment is needed if associated symptoms occur. Glucose may be detected in urine tests, so this should be considered when interpreting test results. Caution is also needed during driving or operating machinery due to the risk of hypoglycemia. There have been reports of increased risk of limb amputation, so care should be taken for foot health. A rare but serious infection called Fournier's gangrene may occur; treatment should be sought immediately if symptoms such as pain or swelling arise. This medication has minimal drug interactions, but caution is needed when used with insulin or diuretics. It is recommended not to use this medication during pregnancy and to avoid administration during breastfeeding. Safety has not been established in children under 18 years of age. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is necessary based on clinical conditions. This medication should be kept out of reach of children, and transferring to other containers should be avoided.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urosepsis
• pyelonephritis
• Fournier's gangrene
• severe rashes
• blisters
• skin peeling
• pain in mouth/eyes mucosa

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• and other genital infections
• increased urination
• rash
• itching
• headache
• dizziness
• indigestion

This medication must be stored in a tightly sealed container to protect it from air or moisture. The recommended storage temperature is between 1 degree and 30 degrees Celsius.

Appearance

Pale yellow, double convex, 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