Zadiempa Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dosage of this medication for both monotherapy and adjunct treatment with insulin or other antihyperglycemic agents is 10 mg once daily. If there is a need for additional blood sugar control, it can be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take double the dose on the same day.

This medication should not be used by patients who are allergic to the active ingredient or other components of this medication. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired renal function, end-stage renal disease, or those undergoing dialysis should not use this drug. Patients with genetic lactose intolerance should also avoid this medication due to the lactose it contains. For patients with mildly impaired renal function, dosage adjustment is necessary, and it should be discontinued if renal function is severely compromised. It is not expected to be effective in end-stage renal disease or those undergoing dialysis. Regular monitoring of renal function before and during treatment with this medication is recommended. Caution is advised for patients with mild to moderate heart failure, and its use is not recommended for patients with severe heart failure. When used in conjunction with insulin or sulfonylureas, there may be a risk of hypoglycemia, requiring potential dosage adjustments of those medications. Use of this medication may result in hypoglycemia, genital infections, increased urination, urinary tract infections, decreased blood volume, increased serum creatinine, etc. Hypoglycemia may occur more frequently when combined with insulin or sulfonylureas, so caution is advised. This medication can cause severe ketoacidosis; therefore, if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur, consult a healthcare provider immediately. In elderly patients, particularly those over 75, the risk of fluid loss is increased, so careful observation is necessary, and it is not recommended for those over 85. This medication may increase the risk of dehydration, hypotension, urosepsis, pyelonephritis, and fungal infections of the genital area, so prompt treatment is required if any infection symptoms appear. While taking this medication, glucose may be detected in urine tests, and caution should be taken to avoid hypoglycemia when driving or operating machinery. Long-term use may increase the risk of limb amputation, so foot care is crucial, and if pain or swelling in the perineum occurs, healthcare personnel should be informed immediately. It is advisable not to use this medication during pregnancy, and use should be discontinued if pregnancy is confirmed. During breastfeeding, it is recommended to stop breastfeeding as this medication may secret into breast milk. Safety and efficacy have not been established in pediatric patients under 18 years of age, so the medication should not be used in this population. No specific toxic reactions have been reported in case of overdose; however, appropriate treatment may be necessary depending on clinical status. 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, necrosis of the perineum, severe allergic reactions, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory symptoms accompanied by cough and fever, jaundice (yellowing of the skin or eyes), liver abnormalities, sudden severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, and severe systemic reactions.

Mild side effects

• Hypoglycemia
• vulvovaginitis
• vulvar infections
• balanitis and other genital infections
• increased urination
• urinary tract infections
• decreased blood volume
• difficulty urinating
• thirst
• increased serum lipids

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is also important to avoid extremely hot or cold places and maintain a storage temperature between 1 and 30 degrees Celsius.

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