Trajenta Duo Tablet 2.5/500 mg

Adult dose

The dosage for this medication should not exceed the maximum recommended doses of linagliptin 2.5 mg and metformin 1000 mg twice daily, determined based on each patient's current therapy, efficacy, and tolerability. This medication is administered twice daily with meals. To reduce gastrointestinal side effects associated with metformin, dosage increases should be gradual. 1. If not currently being treated with metformin: In cases where previous diabetes medication treatment has not been experienced and sufficient blood glucose control cannot be achieved with monotherapy, the initial dosage of this medication 2.5/500 mg should be taken as one tablet twice daily, and can be increased to 2.5/1000 mg as one tablet twice daily. 2. In cases transitioning from a dual therapy of linagliptin and metformin: Patients switching from a dual therapy of linagliptin and metformin should take the same dosage of linagliptin and metformin as previously administered as their initial dosage. 3. In cases where sufficient blood glucose control cannot be achieved with the combination of insulin and metformin: The initial dosage of this medication should be considered to be linagliptin 2.5 mg twice daily (total 5 mg daily) and a similar dosage to the existing metformin dosage. When administered alongside insulin, dosage reduction of the insulin may be necessary in order to minimize the risk of hypoglycemia (refer to the cautionary statements regarding the patients that should be treated carefully). Studies assessing the safety and efficacy of switching to this medication from other oral hypoglycemic agents have not been conducted. Any changes in type 2 diabetes therapy may affect blood glucose control, so monitoring should be performed appropriately. Renal impairment patients: This medication can be used with adjustments in dosage only in patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] 45 ≤ ~ < 60 ml/min or estimated glomerular filtration rate (eGFR) 45 ≤ ~ < 60 mL/min/1.73 m2) without other symptoms that may increase the risk of lactic acidosis. The starting dosage of metformin should not be initiated at 500 mg or 850 mg once daily, as maximum recommended dose for metformin is 500 mg twice daily. Renal function should be closely monitored every 3 to 6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicating a decline in renal function occurs, this medication should be immediately discontinued. Hepatic impairment patients: This medication should not be administered to patients with liver dysfunction due to the presence of metformin (refer to the cautionary statements regarding the patients that should not be treated).

This medication requires caution as it may cause a serious side effect known as lactic acidosis. It should not be administered to patients with severely impaired kidney function, liver dysfunction, acute infections, or severe trauma. Use is also contraindicated in patients with hypersensitivity to this medication, type 1 diabetes, diabetic ketoacidosis, pregnant women, and nursing mothers. Additionally, it is advisable not to administer this medication to patients with acute or chronic alcohol intoxication. Caution is warranted when used in conjunction with sulfonylureas or insulin due to the risk of hypoglycemia, and the elderly or heart failure patients with diminished kidney function should be treated carefully. When using iodinated contrast agents for radiological examinations, there is a risk of kidney failure, hence medication should be temporarily halted before and after the examination. Rare side effects such as acute pancreatitis or bullous pemphigoid may occur, so if symptoms like abdominal pain or skin rash occur, immediate notification of a physician and discontinuation of the medication is necessary. Prolonged use may lead to vitamin B12 deficiency, therefore vitamin B12 levels should be checked in cases of anemia or neurological symptoms. Women who are pregnant or planning to become pregnant should avoid administration, and this medication is not recommended for children and adolescents. Elderly patients are at a higher risk of decreased kidney function; hence, regular monitoring of kidney function is required, and treatment should commence at the minimum dosage. In the event of an overdose, there is a risk of lactic acidosis, and immediate medical attention should be sought; blood dialysis may be necessary. This medication should be stored out of reach of children and kept away from moisture.

Serious side effects

Hives, angioedema, lactic acidosis, pancreatitis, bullous pemphigoid, abnormal liver function tests, hepatitis, chest tightness, shortness of breath, severe swelling (edema), cold sweat, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, difficulty breathing, asthmatic attacks, respiratory abnormalities combined with cough + fever, yellowing of the skin or eyes (jaundice), profound lethargy excessively, sudden

Mild side effects

• Nasopharyngitis
• hypersensitivity
• vitamin B12 reduction and deficiency
• taste disturbance
• cough
• decreased appetite
• diarrhea
• constipation
• nausea
• vomiting

This medication must be stored in a tightly sealed container to protect it from air and moisture. Recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

Biconvex oval film-coated tablet, bright yellow in color

Package unit

60 tablets (10 tablets/Alu-Alu x 6)