Medication info
Janudaum MXR Sustained Release Tablets 100/1000 mg

Janudaum MXR Sustained Release Tablets 100/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Bright blue, bilaterally convex oval sustained-release film-coated tablet
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202201957 · Approved 2022.05.11 · Insurance code 694003910

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg sustained-release tablet should be taken once daily, one tablet per dose. Patients taking the 50/500 mg extended-release or the 50/1000 mg extended-release should take two tablets simultaneously once a day. 1. For patients not currently treated with metformin: The initial dose of this medication is a total daily amount of 100 mg of sitagliptin and 1000 mg of metformin. If there is insufficient blood sugar control, further dosage adjustment may be required.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with type 2 diabetes through the combined action of sitagliptin and metformin. It is primarily used to effectively manage blood sugar while complementing dietary and exercise regimens. Taking this medication can help maintain stable blood sugar levels, contributing to diabetes management. Patients are encouraged to use this medication along with consistent dietary control and exercise for better results. Therefore, this medication is used to improve blood sugar control in type 2 diabetes.

How to take

Adult dose

The 100/1000 mg sustained-release tablet should be taken once daily, one tablet per dose. Patients taking the 50/500 mg extended-release or the 50/1000 mg extended-release should take two tablets simultaneously once a day. 1. For patients not currently treated with metformin: The initial dose of this medication is a total daily amount of 100 mg of sitagliptin and 1000 mg of metformin. If there is insufficient blood sugar control, further dosage adjustment may be required.

Precautions

This medication contains sitagliptin and metformin, which help regulate blood sugar levels. While taking this medication, it is important to note that although rare, serious allergic reactions may occur. If symptoms such as rash, hives, or difficulty breathing appear, discontinue use immediately and consult a doctor. Acute pancreatitis, which is inflammation of the pancreas, may occur; therefore, if symptoms like abdominal pain, vomiting, or nausea arise, careful observation is required, and healthcare professionals should be informed immediately. Patients with impaired kidney function should not use this medication, especially in cases of severe renal impairment or acute renal failure risk. Patients with a sudden decline in heart function or those suffering from acute heart failure should also avoid this medication for safety. Before and after tests involving iodinated contrast agents, this medication should be temporarily discontinued to reduce the risk of kidney damage and lactic acidosis. It is advisable for pregnant women or women who may become pregnant, as well as nursing mothers, to refrain from taking this medication. This medication can cause a rare but serious metabolic disorder known as lactic acidosis, so caution is required in conditions such as dehydration, severe infections, liver dysfunction, or excessive alcohol consumption. Additionally, there is a risk of hypoglycemia; thus, meals should be taken regularly, and when used in combination with other blood sugar-lowering agents, attention to hypoglycemia symptoms is critical. Regular monitoring of kidney function, blood tests, and vitamin B12 levels while on this medication is essential. If physical activity levels suddenly increase or meal patterns become irregular, caution is also advised, and the potential for drug interactions needs to be communicated to healthcare providers. In cases of surgery, severe infections, or trauma, this medication should be temporarily discontinued and resumed once the condition stabilizes. If severe joint pain or skin blistering occurs during this medication use, immediate consultation with a doctor is necessary. Lastly, when prescribing this medication to elderly patients, careful monitoring of kidney function and dosage adjustment is required.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • severe skin rashes
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • acute renal failure
  • elevated liver enzymes
  • severe and disabling joint pain
  • bullous pemphigoid
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  • liver dysfunction (jaundice)
  • severe lactic acidosis
  • difficulty breathing
  • severe hypoglycemia
  • serious neurological symptoms
  • severe swelling or urination problems

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • muscle pain
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • constipation

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Also, avoid places that are too hot or too cold, and it is important to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Bright blue, bilaterally convex oval sustained-release film-coated tablet

Package unit

28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.