Janugrin Duo Tablet 50/500 mg

Adult dose

The dosage of this medication should not exceed the maximum recommended daily doses for each active ingredient, which are sitagliptin 100 mg and metformin 2000 mg, considering each patient's current treatment regimen, efficacy, and tolerability. This medication is generally taken twice a day with food, and the dose should be gradually increased to minimize gastrointestinal side effects caused by metformin. 1. For patients currently treated with metformin who: - Have no prior experience of diabetes medication treatment, find it difficult to achieve sufficient blood sugar control with monotherapy, or cannot achieve sufficient blood sugar control with sitagliptin monotherapy: the initial dosage of this medication is 50/500 mg, taken twice a day, with one tablet per dose, and it can be escalated to 50/1000 mg taken twice a day, with one tablet per dose. - Patients with renal impairment who are reducing the dose of sitagliptin should not switch to this medication (refer to precautions). 2. For patients being treated with metformin: - The recommended initial dose of this medication for patients unable to achieve sufficient blood sugar control with metformin monotherapy is the total daily dose of sitagliptin 50 mg taken twice a day (total daily dose 100 mg) alongside the current dose of metformin. - Patients switching from sitagliptin and metformin combination therapy can commence at their usual doses of sitagliptin and metformin. 3. For patients who are unable to achieve sufficient blood sugar control with metformin in combination with sulfonylureas, metformin in combination with insulin, or metformin combined with thiazolidinediones: The initial dosage of this medication is sitagliptin 50 mg taken twice a day (total daily dose 100 mg), while the initial dosage of metformin must consider the patient's blood sugar levels and existing dosing. To reduce gastrointestinal adverse effects from metformin, doses should be gradually increased. When administered alongside sulfonylureas or insulin, consideration should be given to reduce either sulfonylurea or insulin doses to minimize the risk of hypoglycemia (refer to precautions). There has been no study on the safety and efficacy of switching to this medication from another oral hypoglycemic agent. Any changes in the treatment regimen for type 2 diabetes may lead to changes in blood sugar control; therefore, careful monitoring is required. For patients with renal impairment, this medication can be utilized with the following dosing adjustments for those in stage 3a moderate renal impairment (creatinine clearance [CrCl] ≥ 45 and < 60 mL/min or estimated GFR [eGFR] ≥ 45 and < 60 mL/min/1.73m2), provided no accompanying symptoms that could increase the risk of lactic acidosis are present. The starting dose of metformin is 500 mg or 850 mg administered once daily, so treatment should not be initiated with this medication. The maximum recommended dose of metformin is 500 mg twice daily. Renal function must be carefully monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2, the medication should be discontinued immediately. For patients with liver dysfunction, this medication should not be administered due to the metformin component (refer to precautions).

This medication can cause rare but serious allergic reactions, so if symptoms such as rash, difficulty breathing, or swelling of the face or lips occur after taking the medication, discontinue use immediately and consult a doctor. This medication can cause severe inflammation of the pancreas known as pancreatitis; therefore, if abdominal pain, vomiting, or fever develops while taking it, immediately inform healthcare personnel. One of the ingredients in this medication can cause a rare complication called lactic acidosis, which can lead to an excessive buildup of lactic acid in the body, creating a hazardous condition. If symptoms such as vomiting, abdominal pain, weakness, or difficulty breathing arise, seek medical attention promptly. Patients with poor kidney function or acute renal failure, severe heart failure, myocardial infarction, or severe infections should not take this medication. It is advisable for women who are pregnant or may become pregnant, as well as nursing mothers, to avoid using this medication. Hypoglycemia symptoms such as dizziness, cold sweat, or severe fatigue may occur while taking this medicine, so immediately check blood sugar levels and take appropriate measures if necessary. Dosage adjustment may be required based on kidney function, and kidney function should be monitored regularly through blood tests. Before surgery or imaging tests using radiation contrast agents, this medication should be temporarily discontinued, resuming only after kidney function has returned to normal. Excessive alcohol consumption should be avoided while taking this medication, as alcohol can increase the risk of lactic acidosis. If sudden joint pain or skin blisters occur, promptly inform a doctor, and medication may need to be discontinued if necessary. The risk of hypoglycemia may increase when taken with other hypoglycemic agents or certain medications, so inform a doctor of any other medications you are taking. This medication has not been established for safety and efficacy in children and adolescents, so it should not be used in these populations. In case of overdose, seek immediate medical attention for appropriate treatment, as this medication can be partially removed through dialysis. During the course of taking this medication, regular blood tests and kidney function checks should be performed, and it is important to consult healthcare personnel if any abnormal symptoms occur.

Serious side effects

• Hives, angioedema, anaphylaxis, rash, Stevens-Johnson syndrome leading to severe allergic reactions.
• Acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis).
• Acute renal failure and worsening of kidney function.
• Shortness of breath (included in reported serious adverse cases).
• Severe symptoms due to hypoglycemia (including confusion of consciousness, seizures).
• Acute lactic acidosis leading to severe metabolic complications.
• Elevated liver enzymes, liver disease.

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 tightly sealed container to prevent exposure to air and moisture and is best kept at room temperature between 1 and 30 degrees Celsius. This helps maintain the effectiveness of the medication for a longer time.

Appearance

Bright pink oval film-coated tablet

Package unit

30 tablets / box [10 tablets/PTPX3]