Dai-Diann Duo Tablets 5/1000 mg

Adult dose

The recommended dose of this medication is 1 tablet, twice a day. The maximum recommended daily dose of empagliflozin is 25 mg, and of metformin, it should not exceed 2000 mg. For patients with insufficient blood sugar control, the recommended dose is empagliflozin 5 mg twice daily (total 10 mg) along with the existing dose of metformin. If well tolerated, empagliflozin may be increased to 25 mg. When transitioning from empagliflozin 10 mg (daily total) to this medication, the existing doses of empagliflozin and metformin should be administered. When coadministering this medication with sulfonylurea or insulin, dose reduction of sulfonylurea or insulin may be considered to decrease the risk of hypoglycemia (refer to precautions section 4, adverse reactions and section 6, interactions). To reduce gastrointestinal side effects related to metformin, this medication should be taken with meals. If a dose is missed, the patient should take it as soon as they remember. However, they should not take a double dose at once, and in such cases, the missed dose should be skipped. Special populations Patients with kidney impairment Dose adjustments are not needed for patients with mild kidney impairment. Since this medication contains metformin, in patients with estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or patients with CrCl of 45-59 ml/min without other symptoms that could increase the risk of lactic acidosis, dose adjustment may be considered. In these patients, the starting dose of metformin is 500 mg or 850 mg once daily, and treatment should begin with individual single doses of empagliflozin and metformin. The maximum daily dose of metformin hydrochloride that can be administered with this medication is 1000 mg, which can be given as two doses of 500 mg each per day. Kidney function should be carefully monitored every 3-6 months (refer to precautions section 3, caution in the following patients 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, the medication should be discontinued immediately (refer to precautions section 2, do not administer to the following patients 2).

This medication can cause a rare but very serious side effect called severe lactic acidosis. Lactic acidosis is a condition characterized by an abnormally high level of lactic acid in the blood, which can be life-threatening without appropriate treatment. This medication can lead to hypoglycemia, a serious condition where blood sugar drops too low, when taken with insulin or sulfonylurea medications, so caution is needed. Patients with moderate to severe impaired kidney function or those in situations that may cause acute kidney injury should not take this medication. Conditions such as dehydration, severe infections, heart failure, and acute myocardial infarction fall into this category. Patients scheduled for surgery should discontinue this medication 48 hours before surgery and may resume it only after normal kidney function has been restored post-surgery. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication due to potential risks to the fetus or newborn. It is also recommended to avoid administering this medication to patients with impaired liver function, as liver dysfunction can increase the risk of lactic acidosis. If certain imaging tests with iodine contrast agents are being performed, the medication should be discontinued before and after the test, and can only be resumed after kidney function is confirmed to be normal. Patients at risk of fluid loss, for example, those in a dehydrated state due to vomiting or diarrhea, should be especially cautious when taking this medication and may need to temporarily stop it if necessary. During the course of this medication, vitamin B12 levels may decrease, so patients on long-term treatment are advised to have regular blood tests to monitor vitamin B12 levels. Alcohol can increase the risk of lactic acidosis, a side effect of this medication, so excessive drinking should be avoided while on treatment. Blood sugar levels and kidney function should be regularly monitored during treatment, and if symptoms of hypoglycemia, infection, abdominal pain, difficulty breathing, or lethargy occur, immediate consultation with medical personnel is required. Additionally, this medication may increase urine output, so if there is an increase in urination or discomfort, it is advised to inform medical personnel. Elderly patients are at higher risk of decreased kidney function and fluid loss, so caution is required when taking this medication, and regular kidney function tests are recommended. Finally, the safety and efficacy of this medication have not been established in children, so it is not recommended for those under 18 years of age.

Serious side effects

• Hives
• severe swelling (edema)
• liver dysfunction (jaundice)
• ketoacidosis
• lactic acidosis
• angioedema
• perineal necrosis
• pyelonephritis and urosepsis
• severe allergic reactions
• severe skin reactions

Mild side effects

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

This medication can be sensitive to air and humidity, so it must be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's effectiveness over time.

Appearance

A yellow, brownish, double-convex, oval film-coated tablet

Package unit

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