Zadiglimet Tablet 12.5/850 mg (Empagliflozin 2L-Proline, Metformin)

Adult dose

The recommended dose of this drug is 1 tablet once, twice a day. The dosages should be determined considering the current treatment regimen, efficacy, and tolerance for each patient, ensuring that it does not exceed the maximum recommended daily dose of 25 mg of empagliflozin and 2000 mg of metformin. - For patients who cannot achieve sufficient blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice a day (total daily amount 10 mg) and the prescribed dose of metformin.

This medicine is used to treat diabetes and helps lower blood sugar levels. However, rare side effects such as severe lactic acidosis may occur, which is very dangerous and requires immediate treatment. Additionally, caution is advised as hypoglycemia may occur when taken with insulin or sulfonylureas. This medicine should not be administered to certain patients, particularly those with moderate to severe renal impairment, acute infections or dehydration, type 1 diabetes, acute or unstable heart failure, women who are pregnant or nursing, etc. Patients with slightly decreased kidney function or who are at risk of fluid loss should use this medicine cautiously and undergo regular kidney function tests. Furthermore, dose adjustments may be necessary when taken concomitantly with insulin or insulin secretagogues to reduce the risk of hypoglycemia. While taking this medication, side effects such as hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, diarrhea, abdominal pain, decreased appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, erythema, headache, dizziness, orthostatic dizziness, drowsiness, thirst, increased serum lipids, elevated hematocrit, decreased and deficiency of Vitamin B12, weight loss, insomnia, vulvar pruritus, genital pruritus, chest discomfort, chest pain, weakness, facial symptoms, etc., may occur. Lactic acidosis may present with symptoms such as vomiting, abdominal pain, difficulty breathing, and weakness, so if these symptoms appear, consult a doctor immediately. Furthermore, care should be taken to prevent dehydration in states at risk of fluid loss, and medication may be temporarily discontinued if necessary. This medicine should be avoided in individuals with poor liver function or those who consume excessive alcohol and should be temporarily discontinued around the time of surgery or iodinated contrast examinations. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medicine for safety. Elderly patients should undergo renal function testing before administration due to the risk of decreased kidney function and be monitored regularly, and it is recommended not to use the maximum dosage. In cases of overdose, serious side effects such as lactic acidosis may occur, requiring immediate hospital treatment and possibly blood dialysis. This medicine is not recommended for children as its safety and efficacy have not been established.

Serious side effects

Hives, angioedema, necrosis of the perineum, ketoacidosis, lactic acidosis, urosepsis and pyelonephritis, severe lactic acidosis, severe allergic reactions, severe edema, severe skin reactions, serious neurological symptoms (stroke, seizures, etc.), acute kidney injury, liver abnormalities (including jaundice-related symptoms), difficulty breathing, asthma attacks, chest tightness, fever, thromboembolism in vascular stents, myocardial infarction, deep vein thrombosis, angina.

Mild side effects

Hypoglycemia, urinary tract infection, genital infection, increased urination, nausea, vomiting, diarrhea, abdominal pain, decreased appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, erythema, headache, dizziness, orthostatic dizziness, drowsiness, thirst, increased serum lipids, elevated hematocrit, decreases and deficiencies of Vitamin B12, weight loss, insomnia, vulvar pruritus, genital pruritus, chest discomfort, chest pain, weakness, facial symptoms.

This medicine may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the drug's effectiveness for a longer time.

Appearance

White film-coated tablets that are oval and biconvex with a pink hue

Package unit

30 tablets/bottle