LinaGent Duo Tablet 2.5/500mg

Adult dose

The dosage of this medication is determined based on each ingredient's maximum recommended dosage, not exceeding LinaGLIPTIN 2.5 mg and Metformin 1000 mg twice daily, considering each patient’s current treatment regimen, efficacy, and tolerability. This medication is administered twice daily with meals. To reduce gastrointestinal side effects related to Metformin use, the dosage increase should be gradual. 1. If not currently receiving treatment with Metformin: For patients who have not previously experienced diabetes medication treatment and find it difficult to achieve sufficient blood glucose control with monotherapy, the initial dose of this medication 2.5/500 mg is to take 1 tablet twice daily, and it can be increased to this medication 2.5/1000 mg, 1 tablet twice daily. 2. When switching from a combination of LinaGLIPTIN and Metformin: Patients switching from a combination therapy of LinaGLIPTIN and Metformin to this medication should take the same dose as they were using before. 3. When adequate blood glucose control cannot be achieved using insulin and Metformin: The initial dose of this medication should consider LinaGLIPTIN 2.5 mg twice daily (total amount of 5 mg daily) and a dosage similar to that of the current Metformin. When administering this medication with insulin, a reduction in insulin dosage may be necessary to reduce the risk of hypoglycemia (see Precautions for Use 3. Refer to patients where caution is required). Studies reviewing the safety and efficacy of this medication for switching from other oral hypoglycemic agents have not been conducted. Any changes in the treatment regimen for type 2 diabetes can affect blood glucose control, so careful monitoring should be performed. Renal impairment patients: This medication may be used with dose 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) who do not have other symptoms that would increase the risk of lactic acidosis. The starting dose of Metformin is 500 mg or 850 mg once daily, so starting treatment with this medication is not advisable. The maximum recommended dose of Metformin is 500 mg twice daily. Renal function should be carefully monitored every 3-6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 and renal function declines, this medication should be discontinued immediately. Liver impairment patients: Due to the Metformin component, this medication should not be used in patients with liver function impairment (see Precautions for Use 2. Do not use in the following patients).

This medication may cause a very rare but serious side effect called lactic acidosis, thus it should not be used in patients with impaired renal function or liver function problems. Patients allergic to this drug’s main components, as well as those with type 1 diabetes or specific types of diabetes such as diabetic ketoacidosis, should also not receive it. Additionally, patients with severe renal impairment, acute infections, heart failure, liver function disorders, acute alcohol intoxication, pregnant women, or nursing mothers should not use this medication. This drug poses a risk of hypoglycemia; thus, it is important to closely monitor blood sugar levels when used with insulin or sulfonylureas, and dosage adjustments may be necessary. Patients with impaired renal function should regularly check renal function before and during treatment, and discontinue medication if their condition worsens. Patients with poor heart function should also use this medication cautiously; rare side effects such as acute pancreatitis or bullous pemphigoid may occur, so consult a physician immediately if any abnormal symptoms appear. This medication may reduce vitamin B12 levels; therefore, regular vitamin B12 tests should be conducted during long-term use. Before and after the administration of iodinated contrast agents used in radiological examinations, this medication should be temporarily discontinued, and it should also be paused for a certain period before and after surgery. Women who are pregnant or planning to become pregnant are advised not to use this medication, and nursing mothers should also avoid it. This medication is not recommended for children under 10 years of age, as its safety and efficacy have not been established. Elderly patients may have reduced renal function; thus, dosage should be adjusted and renal function should be monitored periodically. The effects of this medication on driving or operating machinery are not known; however, hypoglycemia symptoms should be taken into account. Overdose may cause serious side effects such as lactic acidosis; thus, immediate medical treatment should be sought, and dialysis may be needed. Store this medication in a place where it is not exposed to moisture and out of reach of children, and it is advisable not to transfer it to another container.

Serious side effects

• Urticaria
• angioedema
• severe swelling (edema)
• lactic acidosis
• pancreatitis
• bullous pemphigoid
• chest tightness
• difficulty breathing
• abnormal liver function
• hepatitis

Mild side effects

• Hypoglycemia
• taste disturbance
• cough
• decreased appetite
• diarrhea
• constipation
• nausea
• vomiting
• abdominal pain
• oral ulcer formation

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. In addition, to maintain the efficacy of the drug, it should be stored at room temperature between 1 degree and 30 degrees.

Appearance

Bright yellow, bilaterally convex oval film-coated tablet

Package unit

30 tablets/bottle, 60 tablets/bottle, 100 tablets/bottle, 200 tablets/bottle