Medication info
Janudiem Extended-Release Tablet 100/1000 mg

Janudiem Extended-Release Tablet 100/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.37mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Bright blue, double convex, oval-shaped extended-release film-coated tablets
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300599 · Approved 2023.02.17 · Insurance code 643705450

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
For the medication 100/1000 mg extended-release tablet, take one tablet once daily. For patients taking the 50/500 mg extended-release tablet or 50/1000 mg extended-release tablet, take two tablets simultaneously once daily. 1. For patients who are not currently being treated with metformin: - The initial dose is a total of 100 mg of sitagliptin and 1000 mg of metformin daily. - If the initial dose is not sufficient.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to aid blood sugar control in patients with type 2 diabetes by combining sitagliptin and metformin. It helps in effectively managing blood sugar while adhering to dietary and exercise regimens. Regular intake of this medication will significantly assist in maintaining stable blood sugar levels. It is used for improving blood sugar levels in patients with type 2 diabetes.

How to take

Adult dose

For the medication 100/1000 mg extended-release tablet, take one tablet once daily. For patients taking the 50/500 mg extended-release tablet or 50/1000 mg extended-release tablet, take two tablets simultaneously once daily. 1. For patients who are not currently being treated with metformin: - The initial dose is a total of 100 mg of sitagliptin and 1000 mg of metformin daily. - If the initial dose is not sufficient.

Precautions

This medication contains both sitagliptin and metformin, used in the treatment of diabetes. First, the sitagliptin component can cause rare but serious allergic reactions; if symptoms like rash, hives, or shortness of breath occur, stop taking the medication immediately and consult a doctor. Acute pancreatitis may also occur, thus if symptoms such as abdominal pain, nausea, or vomiting arise, immediate medical attention is required. The metformin component can cause a rare side effect known as lactic acidosis, which is very dangerous; if symptoms such as difficulty breathing, muscle pain, or extreme fatigue appear, seek treatment immediately. This medication should not be administered to patients with moderate to severe renal impairment, acute heart failure, or those with severe infections or dehydration. Prior to and after examinations using iodine-based contrast materials, the intake of this medication should be temporarily suspended, and intake should resume only after confirming that renal function is normal. It is considered safe not to use this medication in pregnant or breastfeeding women and in children under 18 years of age. While taking this medication, it is essential to regularly check not only blood sugar levels but also renal function and blood test results, as a deficiency in Vitamin B12 may occur, necessitating periodic testing. Excessive alcohol consumption should be avoided during treatment, as acute or chronic alcohol intake may increase the risk of lactic acidosis. There is also a risk of hypoglycemia, so caution is needed when skipping meals or engaging in intense exercise, and when used in combination with other blood sugar-lowering agents, particularly be cautious of symptoms of hypoglycemia. Before surgery, the use of this medication should be paused for a period, and after surgery, it should only be resumed once oral intake has returned to normal and renal function has improved. Lastly, this medication may cause gastrointestinal disturbances (diarrhea, nausea, vomiting, etc.), headaches, and cold-like symptoms; if these symptoms persist, consult a physician.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • rash
  • vasculitis
  • Stevens-Johnson syndrome
  • exfoliative skin disease
  • hemoglobin abnormalities
  • acute pancreatitis
  • acute renal failure
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  • severe hypoglycemia
  • severe and debilitating arthralgia
  • bullous pemphigoid
  • liver dysfunction (jaundice)
  • serious allergic reactions
  • severe edema or urination abnormalities
  • serious neurological symptoms
  • difficulty breathing
  • and asthma attacks.

Mild side effects

Diarrhea, upper respiratory infection, headache, nausea, vomiting, abdominal pain, constipation, nasopharyngitis, myalgia, limb pain, back pain, pruritus, hypoglycemia without severe or disabling symptoms, thrombocytopenia, rhabdomyolysis

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

Storage

This medication is sensitive to air and moisture, thus it should be stored in a sealed container. Additionally, it is important to store this medication at room temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Bright blue, double convex, oval-shaped extended-release film-coated tablets

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 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.