Pharma Empagliflozin 10 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with other glucose-lowering medications such as insulin. If the patient tolerates 10 mg well but requires additional blood sugar control, the dose may be increased to 25 mg once daily. This medication can be taken with or without food. The tablet should be swallowed whole. If a dose is missed, it should be taken as soon as it is remembered.

This medication should not be used in patients with known allergies to the active ingredient or any other component. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It is not indicated for patients with significantly impaired kidney function, specifically those with a glomerular filtration rate (GFR) below 30 mL/min/1.73m2, patients with end-stage renal disease, or those undergoing dialysis. Additionally, this medication contains lactose, and it should not be administered to patients with genetic conditions such as lactase deficiency, galactose intolerance, or glucose-galactose malabsorption. Caution is advised when using this medication in patients with impaired kidney function, and treatment should be avoided if the GFR is below 60 mL/min/1.73m2, and it should be discontinued if it falls below 45 mL/min/1.73m2. In patients with end-stage renal disease or those undergoing dialysis, the effectiveness of this medication is not expected, hence it is not used. In patients with mild to moderate heart failure, caution is advised, and it is not recommended for patients with severe heart failure. When used in conjunction with insulin or sulfonylureas, there is a risk of hypoglycemia, and dosage adjustment for these medications may be required. During treatment with this medication, adverse reactions such as hypoglycemia, genital infections, urinary tract infections, increased urination, and fluid volume depletion may occur, necessitating attention. Especially, serious metabolic abnormalities like ketoacidosis can occur rarely; if symptoms like nausea, vomiting, abdominal pain, and difficulty breathing occur, immediate consultation with a healthcare professional is advised. Older adults, particularly those over 75, are at greater risk of fluid volume loss, and caution should be taken to avoid dehydration or hypotension; for those over 85, the use of this medication is not recommended. Since this medication affects blood sugar levels, it may influence certain testing methods during blood glucose monitoring, so it needs to be monitored per medical advice. Women who are pregnant or planning to become pregnant should not use this medication, and breastfeeding mothers should discontinue nursing while using this medication. The safety and efficacy in children under 18 have not been established, so it is not used. In cases of overdose, no specific toxic symptoms have been reported, but appropriate treatment should be sought based on clinical status. This medication should be kept out of the reach of children, and it is advisable not to transfer it to another container. Drug interactions may increase the risk of dehydration or hypotension when used with diuretics, and caution is warranted when used with insulin or insulin secretagogues due to the risk of hypoglycemia. Caution is needed when driving or operating machinery due to the risk of hypoglycemia. Diabetic patients should pay attention to routine foot care and should be cautious regarding the risk of limb amputation. Serious infections such as perineal necrosis can occur rarely, so immediate medical attention should be sought for pain, swelling, fever, or other symptoms around the genital area.

Serious side effects

Hives, severe swelling (angioedema), ketoacidosis, severe skin reactions associated with rash, chest tightness, difficulty breathing, cold sweat, pallor, urosepsis, pyelonephritis, perineal necrosis, shortness of breath or difficulty breathing, asthma attacks, yellowing of the skin or eyes (jaundice), liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, markedly decreased urine output,

Mild side effects

• Hypoglycemia
• diarrhea
• nausea
• gastric ulcer
• colitis
• vomiting
• ischemic colitis
• intestinal bleeding
• vaginitis
• vulvitis

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will safely maintain the effectiveness of the medication.

Appearance

Light yellow, double convex, round film-coated tablet

Package unit

30 tablets/bottle