Medication info
Janudim Extended-Release Tablets 50/500 mg

Janudim Extended-Release Tablets 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Light blue, biconvex, oval-shaped extended-release film-coated tablets
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300601 · Approved 2023.02.17 · Insurance code 643705430

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
Take one extended-release tablet of this medication 100/1000 mg once daily. Patients taking this medication 50/500 mg extended-release tablets or 50/1000 mg extended-release tablets should take two tablets together once daily. For patients not currently being treated with metformin: The initial total daily dosage is 100 mg of sitagliptin and 1000 mg of metformin. If sufficient blood sugar control is not achieved with the initial dosage, the dosage may be gradually increased.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is used in conjunction with dietary management and exercise therapy to assist individuals with type 2 diabetes in controlling their blood sugar levels. Sitagliptin and metformin work together to effectively lower blood sugar levels. This can lead to improved blood sugar management and help prevent complications. Patients can expect good therapeutic effects through consistent use and lifestyle improvements.

How to take

Adult dose

Take one extended-release tablet of this medication 100/1000 mg once daily. Patients taking this medication 50/500 mg extended-release tablets or 50/1000 mg extended-release tablets should take two tablets together once daily. For patients not currently being treated with metformin: The initial total daily dosage is 100 mg of sitagliptin and 1000 mg of metformin. If sufficient blood sugar control is not achieved with the initial dosage, the dosage may be gradually increased.

Precautions

This medication contains sitagliptin and metformin, which are used for diabetes treatment. First, the sitagliptin component may, although rarely, cause serious allergic reactions. Such reactions may include skin rash, hives, difficulty breathing, and severe swelling, which can appear within three months of starting treatment, so caution is advised. Additionally, sitagliptin may potentially cause pancreatitis, an inflammation of the pancreas, therefore, if symptoms such as abdominal pain, vomiting, or severe abdominal discomfort occur, consult a physician immediately. The metformin component can cause lactic acidosis, a rare but serious side effect where lactic acid builds up in the body, indicating that if symptoms such as muscle pain, difficulty breathing, fatigue, or abdominal pain occur, one should stop taking the medication and seek medical attention. This medication should not be used in patients with severe kidney impairment, acute heart failure or myocardial infarction, liver impairment, pregnant or breastfeeding women, and those with specific allergies. During treatment, kidney function should be tested regularly, and if there are conditions such as dehydration or severe infections, the medication should be temporarily discontinued. Furthermore, this medication can cause hypoglycemia, so extra caution is necessary when meals are skipped, exercise is suddenly increased, or when taken with other blood sugar-lowering agents. The medication includes color additives, so patients with allergies to specific dyes should use it cautiously. It is advisable to temporarily stop the medication before and after surgery, and to restart it only after confirming that kidney function is normal following the surgery. Common side effects that may occur during treatment include diarrhea, headache, upper respiratory infections, etc., while rare side effects may include severe joint pain, skin conditions, and muscle pain. Finally, the risk of lactic acidosis can be increased due to alcohol consumption or excessive alcohol intake, thus it is recommended to avoid drinking during treatment with this medication. The safety and efficacy of this medication have not been established in children, and in the elderly, it is necessary to adjust the dosage considering potential declines in kidney function and to conduct regular tests.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), anaphylaxis, angioedema, rash, exfoliative skin diseases (including Stevens-Johnson syndrome), severe allergic reactions
  • Acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis)
  • Acute kidney failure (worsening renal function)
  • Severe and disabling joint pain
  • Bullous pemphigoid
  • Elevation of liver enzymes, liver abnormalities (risk of jaundice)
  • Severe lactic acidosis
  • Severe edema or urination abnormalities
  • Severe allergic reactions

Mild side effects

Diarrhea, upper respiratory infection, headache, nausea, vomiting, abdominal pain, nasopharyngitis, constipation, muscle pain, limb pain, back pain, pruritus, thrombocytopenia, rhabdomyolysis, hypoglycemia, the phenomenon of finding the drug in the stool

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

Storage

This medication is sensitive to air and moisture, hence it should be stored in a tightly sealed container. Avoid extremely hot or cold locations, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Light blue, biconvex, 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.

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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.