Empaja Tablet 10 mg (Empagliflozin 2L-Proline)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other hypoglycemic agents. If tolerance is excellent and additional blood sugar control is needed, 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, take it as soon as remembered and do not double the dosage on the same day.

This medication should not be used in patients with an allergy to the active ingredient or components, in patients with type 1 diabetes, or in those with diabetic ketoacidosis. Patients with impaired kidney function may experience reduced effectiveness of this medication, and regular monitoring of kidney function is required. It is not recommended for patients with certain kidney diseases. When used in conjunction with insulin or insulin secretagogues, the risk of hypoglycemia may increase, thus requiring dosage adjustments of these medications. Although this medication aids blood sugar control, side effects such as hypoglycemia, infections, increased urination, and decreased fluid volume may occur, warranting caution. There may be an increase in genital infections or urinary tract infections, and treatment should be sought immediately if symptoms appear. A serious metabolic disturbance known as ketoacidosis may occur; if symptoms such as vomiting, abdominal pain, or difficulty breathing arise, immediate consultation with medical personnel is required. Elderly patients or those at risk of fluid volume loss should be cautious regarding dehydration or hypotension, and may need to temporarily discontinue this medication if necessary. This medication has reported cases of liver damage, thus liver function tests should be performed if hepatic impairment is suspected. Serious infections such as urinary sepsis, pyelonephritis, and necrotizing fasciitis (a Fournier's gangrene) may occur rarely, and immediate treatment should be sought for related symptoms. Use during pregnancy is not recommended, and breastfeeding should be discontinued if this medication is taken. Safety and efficacy in children and adolescents have not been confirmed, thus it should not be used in this population. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is necessary depending on clinical status. During the course of taking this medication, caution should be exercised while driving or operating machinery regarding the risk of hypoglycemia, especially when used in combination with insulin or sulfonylureas. It is important to maintain routine foot care and infection prevention, and to inform medical staff immediately of any unusual symptoms.

Serious side effects

Urticaria, angioedema, ketoacidosis, urinary sepsis, pyelonephritis, necrotizing fasciitis (Fournier's gangrene), severe allergic reactions, severe ketoacidosis, acute cholecystitis, autoimmune hepatitis, cholelithiasis, acute kidney injury, fever, vascular stent thrombosis, significant adverse drug reactions, acute pyelonephritis, deep vein thrombosis, cerebral infarction, intracranial aneurysm, serious edema or urinary abnormalities, suspected severe liver abnormalities (jaundice).

Mild side effects

Constipation, itching, rash, increased serum creatinine, decreased glomerular filtration rate, increased hematocrit, hypoglycemia (especially when used in combination with insulin or sulfonylureas), vulvovaginal candidiasis, vulvitis, balanitis, genital infections, increased urination, urination difficulties, interstitial nephritis, thirst, headache, dizziness, orthostatic dizziness, drowsiness, fatigue, facial edema, vascular stent stenosis, vascular stent thrombosis, chest pain, delirium.

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for an extended period.

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/bottle