Mgliduo 5/850 mg

Adult dose

The recommended dose for this medication is 1 tablet taken twice daily. The dosage should be determined based on the patient's treatment regimen, efficacy, and tolerability, without exceeding empagliflozin 25 mg and metformin 2000 mg daily. For patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications, administer 5 mg of empagliflozin twice a day along with the current dose of metformin. If the patient has good tolerability at a total daily dose of empagliflozin 10 mg and additional blood sugar control is needed, the dose may be increased to 25 mg of empagliflozin (total daily dose). For patients switching from a combination of empagliflozin (total daily doses of either 10 mg or 25 mg) and metformin to this medication, administer the previous doses of empagliflozin and metformin. When using this medication with sulfonylureas or insulin, consider reducing the dosage of sulfonylureas or insulin to decrease the risk of hypoglycemia (refer to warnings in usage precautions 4. Adverse reactions and 6. Interactions). This medication should be taken with meals to minimize gastrointestinal adverse effects related to metformin. If a dose is missed, take it as soon as remembered. However, do not take two doses at once; in such cases, skip the missed dose. Special populations: Patients with renal impairment: No dosage adjustment is necessary for patients with mild renal impairment. Due to the containing metformin, dosage adjustments may be considered for patients with estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or CrCl of 45-59 ml/min in the absence of other symptoms that increase the risk of lactic acidosis. For these patients, the initial dose of metformin should be 500 mg or 850 mg once daily; and therapy should be started with individual monotherapy of empagliflozin and metformin. The maximum daily dosage of metformin hydrochloride that can be administered with this drug is 1000 mg, which may be divided into two doses of 500 mg each, taken twice daily. Monitor kidney function closely every 3-6 months (refer to usage precautions, 3. Consider using cautiously in the following patients, section 1)). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, this medication should be discontinued immediately (refer to usage precautions 2. Do not administer to the following patients, section 2)). Elderly patients: Patients aged 75 or older should be cautious considering the risks of renal function decline and reduced fluid volume.

This medication is primarily used for the treatment of diabetes, assisting in blood sugar control. It may cause a rare side effect known as severe lactic acidosis, so patients with impaired kidney function, severe infection, dehydration, or heart problems should not take it. Care should also be taken when used in combination with insulin or sulfonylureas, as hypoglycemia may occur. Patients with decreased kidney function, acute illness, severe infection, or those scheduled for surgery should temporarily discontinue this medication until kidney function has returned to normal. It is also considered safe not to use this medication in patients with liver dysfunction or in those with heart failure or hypoxia. This medication may increase the risk of urinary and genital infections; if symptoms of such infections occur, consult a doctor immediately. Regular monitoring of blood sugar levels, kidney function, and vitamin B12 levels during treatment is crucial. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, and it is not recommended for children. Elderly patients should be cautious due to the potential for decreased kidney function, requiring dosage adjustments and regular monitoring of kidney function. In the event of overdose, there is a risk of lactic acidosis or hypoglycemia, so seek appropriate medical treatment immediately. When storing this medication, keep it out of reach of children and store it in its original container.

Serious side effects

Urticaria, severe swelling (edema), angioedema, necrosis of the perineum, urosepsis, pyelonephritis, ketoacidosis, lactic acidosis, liver abnormalities (abnormal liver function tests, hepatitis, acute cholecystitis, autoimmune hepatitis, cholelithiasis, hepatitis), severe allergic reactions, severe skin adverse reactions (severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes), respiratory problems (difficulty breathing or shortness of breath, asthma attacks, coughing accompanied by fever)

Mild side effects

• Hypoglycemia
• urinary tract infection
• genital infection
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius to prolong its effectiveness and prevent deterioration.

Appearance

Biconvex, oval-shaped, white film-coated tablet with a yellowish tint

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 60 tablets/bottle