Zdapragliflozin 10 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is once daily at 10 mg for monotherapy or additional combination therapy with insulin and other glucose-lowering agents. If the 10 mg dosage is well tolerated and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. This medication can be administered regardless of meals. The tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered.

This medication should not be used by certain patients. First, patients who are allergic to this medication's active ingredients or components should not take it. It should also not be used in patients with type 1 diabetes or diabetic ketoacidosis. It is contraindicated in patients with severely impaired kidney function, specifically with a glomerular filtration rate of less than 30 mL/min/1.73m² or those with end-stage kidney disease or who are on dialysis. Moreover, this medication contains lactose; therefore, patients with genetic issues such as lactose intolerance, lactose deficiency, or glucose-galactose malabsorption should not take it. Caution should be exercised when using in patients with slightly impaired kidney function. For patients with a glomerular filtration rate of less than 60 mL/min/1.73m², it is advisable not to initiate treatment with this medication. If a patient tolerates this medication well but continues to have decreasing kidney function, dosage adjustment or discontinuation should be considered. There is no expected efficacy of this medication in patients with end-stage kidney disease or those on dialysis. Regular monitoring of kidney function before and during medication use is essential. In patients with heart failure classified as NYHA class I-II, it should be used cautiously and is not recommended for class III-IV patients. When used with insulin or sulfonylureas, there is a risk of hypoglycemia, and dosage reduction of these agents may be necessary. Various adverse reactions may occur while taking this medication. The most common side effects include hypoglycemia, genital infections (such as vulvovaginitis in women), urinary tract infections, increased urination, and decreased fluid volume. Hypoglycemia, in particular, can occur more frequently when combined with insulin or sulfonylureas, so blood sugar levels should be monitored closely. Rarely, serious side effects such as ketoacidosis, pyelonephritis, rash, urticaria, angioedema, and perineal necrosis have been reported, so if any unusual symptoms arise, immediate consultation with a physician is warranted. This medication can induce severe ketoacidosis; therefore, if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur, prompt notification to healthcare providers is necessary. Elderly patients, particularly those over 75 years, have a higher risk of fluid loss, so careful monitoring is advised, and initiation is not recommended for those over 85 years. Patients at risk of fluid loss, such as those with hypotension or cardiovascular diseases, should monitor blood pressure and fluid status closely when taking this medication. This medication may affect driving or operating machinery, particularly in the presence of hypoglycemia risk. Pregnant women should avoid taking this medication, and breastfeeding women are advised to discontinue breastfeeding. The safety and efficacy of this medication have not been established in children under the age of 18. No specific toxic reactions have been reported in case of overdose; however, if overdose occurs, careful monitoring of the patient's condition and appropriate treatment should be undertaken. Finally, this medication should be kept out of the reach of children and should not be transferred to another container.

Serious side effects

• Urticaria
• angioedema
• perineal necrosis
• ketoacidosis
• urinary sepsis
• pyelonephritis
• severe allergic reactions
• severe skin adverse reactions
• difficulty breathing
• asthma attacks

Mild side effects

Hypoglycemia, vulvovaginitis, balantitis and other genital infections, increased urination, rash, itching, increased serum lipids, increased blood creatinine, decreased glomerular filtration rate, abnormal diagnostic tests (lipids, creatinine, etc.), fatigue, peripheral edema, facial edema, fever, facial swelling, chills, odd feelings, swelling, pain, headache, dizziness, drowsiness, constipation, diarrhea, dyspepsia, abdominal pain, nausea,

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius to preserve its efficacy and safety.

Appearance

Light yellow, round, biconvex film-coated tablets

Package unit

30 tablets/bottle