Janudim Tablet 50/850 mg

Adult dose

The dosage of this medication is determined considering the current treatment regimen, efficacy, and tolerability of each patient, and should not exceed the maximum recommended daily dosage of sitagliptin 100 mg and metformin 2000 mg. This medication is typically taken twice daily with food, with gradual dosage increase to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients who are not currently treated with metformin: If there is no prior experience with diabetes medication and sufficient blood glucose control is difficult with monotherapy or if sufficient blood glucose control cannot be achieved with sitagliptin monotherapy, the initial dosage is 50/500 mg of this medication, taken twice daily as one tablet at a time, with potential increase to 50/1000 mg, taken twice daily as one tablet each time. Patients currently receiving reduced doses of sitagliptin due to renal impairment should not be switched to this medication (refer to Usage Precautions 2. Do not administer to the following patients). 2. For patients currently treated with metformin: - The recommended initial dosage of this medication for patients unable to achieve adequate blood glucose control with metformin monotherapy is a total daily amount of sitagliptin 50 mg twice daily (total daily amount 100 mg) plus existing metformin dosage. - Patients transitioning from sitagliptin and metformin combination therapy can start at existing dosages of sitagliptin and metformin. 3. For patients unable to achieve adequate blood glucose control with combination therapy of metformin and sulfonylureas, metformin and insulin, metformin and thiazolidinediones: The initial dosage of this medication is sitagliptin 50 mg twice daily (total daily amount 100 mg), while the initial dosage of metformin should be determined based on the patient's blood glucose levels and existing dosages. To reduce gastrointestinal adverse reactions caused by metformin, the dosage should be gradually increased. When co-administered with sulfonylureas or insulin, dosage reduction may be considered to decrease the risk of hypoglycemia (refer to Usage Precautions 5. General Precautions). No studies have been conducted to assess the safety and efficacy of switching from other oral hypoglycemic agents to this medication. Any change in the treatment regimen for type 2 diabetes may affect blood glucose control, so caution is necessary and appropriate monitoring should be done. For patients with renal impairment: This medication may be used with dosage adjustments for stage 3a moderate renal impairment (creatinine clearance [CrCl] ≥ 45 and < 60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73m²) provided that they do not present other symptoms increasing the risk of lactic acidosis. The starting dose of metformin should be 500 mg or 850 mg once daily, therefore treatment should not be initiated with this medication. The maximum recommended dose of metformin is 500 mg twice daily. Renal function should be closely monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m² occurs, this medication should be discontinued immediately. For patients with liver impairment: This medication should not be administered to patients with liver dysfunction due to the metformin component (refer to Usage Precautions 2. Do not administer to the following patients).

This medication is used for the treatment of diabetes and precautions are necessary as severe allergic reactions or skin disorders may occur during use. This medication carries the risk of pancreatitis, which is inflammation of the pancreas, so if symptoms such as abdominal pain or vomiting occur after taking it, consult a doctor immediately. Additionally, this medication can cause a rare but life-threatening metabolic disorder known as severe lactic acidosis, and should not be taken by patients with poor kidney function or liver impairment. This medication should not be administered to patients with certain renal impairment, acute heart failure, acute myocardial infarction, serious infections, pregnant or nursing women, etc. While taking this medication, it is important to be cautious about irregular eating, excessive exercise, and interactions with other medications, and those allergic to the colorants included in this medication should take extra care. Side effects may include diarrhea, nausea, headache, upper respiratory tract infections, and particularly symptoms of hypoglycemia, so blood sugar levels should be monitored closely. Signs of lactic acidosis include fatigue, muscle pain, difficulty breathing, and abdominal pain. If these symptoms occur, stop taking the medication immediately and notify healthcare personnel. Dosage adjustments based on kidney function should be made, and regular kidney function tests should be performed before and during treatment. Alcohol intake may increase the risk of lactic acidosis, therefore it is advisable to avoid excessive drinking while on this medication. If undergoing surgery, this medication should be stopped 48 hours before the procedure, and resumed only after confirmed normal kidney function post-surgery. Elderly patients may have reduced kidney function, so caution is necessary when taking this medication, and regular kidney function testing is recommended. In case of an overdose, immediate hospital visit for proper treatment is necessary, and the medication may be removed via blood dialysis. Pregnant or potentially pregnant women, as well as nursing mothers, are advised against use of this medication for safety. The safety and efficacy of this medication for children under 18 have not been established, so it is best not to administer it to children. If skin rash, hives, severe joint pain, or bullous diseases occur, consult a doctor immediately. There may be an increased risk of hypoglycemia when using this medication in combination with other hypoglycemic agents or insulin, thus dosage adjustments may be necessary. During treatment, regular blood glucose, kidney function, liver function, and hematological tests should be conducted to monitor health status. If any suspicious abnormal symptoms arise, it is important to immediately inform healthcare personnel and receive appropriate measures.

Serious side effects

• Hives
• angioedema
• anaphylaxis
• Stevens-Johnson syndrome
• severe skin reactions
• acute pancreatitis
• acute renal failure
• difficulty breathing
• unstable angina
• acute pancreatitis

Mild side effects

• Diarrhea
• upper respiratory tract infection
• headache
• nausea
• vomiting
• abdominal pain
• nasopharyngitis
• constipation
• muscle pain
• limb pain

This medication should be stored in a sealed container to prevent air from entering and kept at room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the effectiveness of the medication for a longer period.

Appearance

Pink oval film-coated tablet

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle