Medication info
Janux XR Extended-Release Tablet 50/500 mg (Sitagliptin, Metformin)

Janux XR Extended-Release Tablet 50/500 mg (Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
Bright blue, oval, bilayered extended-release film-coated tablet
Packaging
28 tablets/bottle, 30 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202201873 · Approved 2022.05.09 · Insurance code 649703020,653806560

Summary

Main use
Improvement in blood glucose control for type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication should be determined based on each patient’s current treatment regimen, effectiveness, and tolerance, ensuring it does not exceed the maximum recommended daily doses of sitagliptin 100 mg and metformin 2000 mg. This medication is taken once daily in the evening with a meal to reduce gastrointestinal side effects associated with metformin, and the dosage is increased gradually. To maintain the extended-release characteristics, do not split, crush or chew this medication.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Improvement in blood glucose control for type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with type 2 diabetes by the combined action of sitagliptin and metformin. When used in conjunction with diet and exercise regimens, it can effectively improve blood sugar levels. Therefore, this medication is used to enhance blood glucose control in type 2 diabetes patients.

How to take

Adult dose

The dosage of this medication should be determined based on each patient’s current treatment regimen, effectiveness, and tolerance, ensuring it does not exceed the maximum recommended daily doses of sitagliptin 100 mg and metformin 2000 mg. This medication is taken once daily in the evening with a meal to reduce gastrointestinal side effects associated with metformin, and the dosage is increased gradually. To maintain the extended-release characteristics, do not split, crush or chew this medication.

Precautions

This medication contains both sitagliptin and metformin. Sitagliptin can rarely cause serious allergic reactions, so if symptoms such as rash, difficulty breathing, or swelling of the face or lips occur after taking it, you must stop taking it immediately and consult a doctor. Additionally, sitagliptin can cause pancreatitis, which is inflammation of the pancreas, so if symptoms such as abdominal pain, nausea, vomiting, or fever occur, you should inform a healthcare professional immediately. Metformin can cause lactic acidosis, a rare but potentially fatal metabolic disorder, so if symptoms such as sudden muscle pain, difficulty breathing, fatigue, or abdominal pain appear, you should stop taking it immediately and visit a hospital. This medication should not be administered to patients with moderate to severe renal impairment, those with acute cardiovascular disease or acute infection, and women who are pregnant or nursing. Moreover, this medication must be discontinued before undergoing procedures using iodine contrast agents, and can only be resumed after kidney function is confirmed to be normal following the procedure. During treatment, it is essential to have regular kidney function and blood tests, and it’s recommended to periodically check vitamin B12 levels. This medication may interact with other hypoglycemic agents, alcohol, and certain medications, so you must inform your doctor or pharmacist if you are taking any other medications. Hypoglycemia may occur, so meals should be regular, sudden exercise or skipping meals should be avoided, and sugar should be consumed immediately in case of hypoglycemic symptoms. If surgery is planned, the medication should be stopped 48 hours before the procedure, and can be resumed only after kidney function is confirmed to be normal post-surgery. During treatment with this medication, if severe joint pain or skin blisters or rashes occur, you must notify a doctor immediately and receive treatment. Elderly patients are at increased risk of reduced kidney function, thus dosage adjustments and regular examinations are necessary. The safety and efficacy of this medication in children and adolescents under 18 years old have not been sufficiently proven, hence use is not recommended.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • rash
  • cutaneous vasculitis
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • acute renal failure
  • increased liver enzymes
  • bullous pemphigoid
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  • rhabdomyolysis
  • severe hypoglycemia
  • lactic acidosis

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nasopharyngitis
  • constipation
  • vomiting
  • abdominal pain
  • muscle pain
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • severe joint pain with disability

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius. Proper storage ensures the long-term efficacy and safety of the medication.

Appearance and packaging

Appearance

Bright blue, oval, bilayered extended-release film-coated tablet

Package unit

28 tablets/bottle, 30 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.