Linagliptin Duo Tablet 2.5/850 mg

Adult dose

The dosage of this medication should be determined by considering each component's maximum recommended dose of linagliptin 2.5 mg and metformin 1000 mg not exceeding 2 times per day based on each patient's current treatment regimen, efficacy, and tolerability. This medication is taken twice daily with meals. To reduce gastrointestinal side effects related to metformin, the dosage increases should proceed gradually. 1. If not currently treated with metformin: For patients who have not previously been treated with other diabetes medications and find it challenging to achieve adequate blood sugar control with monotherapy, the initial dosage of this medication is Linagliptin 2.5/500 mg, taking 1 tablet twice a day, and it can be increased to Linagliptin 2.5/1000 mg, 1 tablet twice a day. 2. If unable to achieve adequate blood sugar control with metformin monotherapy: The initial dosage of this medication is Linagliptin 2.5 mg twice a day (a total of 5 mg per day) and the existing dosage of metformin (e.g., for a patient taking metformin 1000 mg twice daily, Linagliptin 2.5 mg/metformin 1000 mg is taken twice daily with meals). 3. When switching from combination therapy with linagliptin and metformin: Patients converting to this medication from combination therapy with linagliptin and metformin should initiate treatment based on their current dosages of linagliptin and metformin. 4. If unable to achieve adequate blood sugar control with combination therapy of metformin and sulfonylureas: The initial dosage of this medication should consider Linagliptin 2.5 mg twice a day (a total of 5 mg per day) and a dosage similar to that of the current metformin prescription. When co-administering this medication with sulfonylureas, dose reduction of sulfonylureas may be necessary to reduce the risk of hypoglycemia (refer to usage precautions, section 2. administer with caution in the following patients). 5. If unable to achieve adequate blood sugar control with combination therapy of insulin and metformin: The initial dosage should consider Linagliptin 2.5 mg twice a day (a total of 5 mg per day) and a dosage similar to that of the current metformin prescription. When co-administering this medication with insulin, insulin dosage reduction may be necessary to reduce the risk of hypoglycemia (refer to usage precautions, section 2. administer with caution in the following patients). No studies have been conducted to evaluate the safety and efficacy of switching from other oral glucose-lowering medications to this drug. Any change in therapy for type 2 diabetes may affect blood sugar levels, so caution and appropriate monitoring should be undertaken. In patients with impaired renal function: This medication may be used with appropriate dosage adjustments 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), if no other symptoms increasing the risk of lactic acidosis are present. The starting dosage of metformin is 500 mg or 850 mg once daily, so this medication must not be initiated. The maximum recommended dosage for metformin is 500 mg twice daily. Renal function should be carefully monitored every 3 to 6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73 m2, this medication should be discontinued immediately. In patients with liver impairment: This medication should not be administered to patients with liver dysfunction due to the metformin component. (Refer to usage precautions, section 1. do not administer to the following patients).

This medication is designed to assist in blood sugar control and one of its main ingredients is metformin hydrochloride. Metformin hydrochloride can cause a rare but serious side effect called lactic acidosis, so caution is necessary. This medication should not be administered to certain patients. For example, patients allergic to this medication or its components, patients with type 1 diabetes, lactic acidosis or diabetic ketoacidosis, patients with severe kidney dysfunction, patients with acute infections or severe dehydration can be at risk when taking this medication. Additionally, patients with poor liver function, those with alcoholism or malnutrition, and pregnant or breastfeeding women are advised against taking this medication. Caution should be taken with hypoglycemia while taking this medication, especially when combined with other glucose-lowering agents or insulin. Symptoms of hypoglycemia may include dizziness, cold sweat, severe fatigue, etc. To reduce the risk of lactic acidosis, kidney function should be monitored regularly, and if renal function declines, this medication should be discontinued or adjusted. In situations where kidney function deteriorates rapidly, immediate consultation with healthcare professionals is required. Patients with weakened heart function should also be observant when taking this medication. Moreover, if iodine-based contrast agents are administered during radiological examinations, this medication should be temporarily discontinued. This medication may trigger acute pancreatitis and conditions such as blistering dermatitis, so if severe abdominal pain or blisters on the skin occur while taking it, immediate consultation with a doctor is necessary. It can reduce vitamin B12 levels, so patients taking it for long periods are advised to regularly check vitamin B12 levels. This medication may interact with other drugs, so if other medications are being taken, it is essential to inform healthcare providers, particularly when co-administering drugs that may affect kidney function. Pregnant women or those planning pregnancy are recommended not to take this medication, and breastfeeding women should also avoid taking it. It is not recommended for children under 10 years old and adolescents aged 10 to 17, as safety and efficacy have not been established for this age group. Elderly patients may have decreased kidney function, so it is advisable to regularly monitor kidney function before and during the use of this medication and to administer it at the lowest possible dose. In the event of an overdose, there is a risk of lactic acidosis, and patients should visit a medical institution immediately for appropriate treatment. This medication should be stored away from moisture and direct sunlight and kept out of reach of children.

Serious side effects

Urticaria, angioedema, lactic acidosis, pancreatitis, blistering dermatitis, liver dysfunction (abnormal liver function tests, hepatitis), angina, acute myocardial infarction, unstable angina, congestive heart failure, cardiac arrest, acute renal failure, asthma, dyspnea, hypertension, and severe edema, severe allergic reactions, cerebral infarction, seizures, confusion, visual disturbances, paralysis, severe headaches, acute kidney injury, end-stage renal disease, acute cholangitis,

Mild side effects

Nasopharyngitis, hypersensitivity, vitamin B12 reduction and deficiency, hypoglycemia (when used with sulfonylureas), taste disturbance, cough, decreased appetite, diarrhea, constipation (when used with insulin), nausea, vomiting, abdominal pain, formation of oral ulcers, liver function test abnormalities, hepatitis, pruritus, erythema, rash, severe and disabling arthralgia, rhabdomyolysis, increased lipase, increased amylase, angioedema, vitamin B12 deficiency, fatigue,

This medication is sensitive to air and moisture, so it should be stored in a sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius to maintain the medication's efficacy for a longer period.

Appearance

Bright orange oval film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTPX6)]