Medication info
Janudau Tablet 50 mg (Sitagliptin Hydrochloride Monohydrate)

Janudau Tablet 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Pale yellowish pink, round, biconvex film-coated tablets
Packaging
30 tablets/box (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 202004026 · Approved 2020.05.29 · Insurance code 694003150

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage is 100 mg once daily, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with kidney impairment, dosage adjustments may not be necessary for mild and moderate kidney impairment (eGFR 45 or greater but less than 90). In moderate kidney impairment with an eGFR of 30 to less than 45, give 50 mg once daily.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood glucose control in patients with type 2 diabetes
View approved original text

This medication is used to help regulate blood sugar levels in patients with type 2 diabetes. It can be used as monotherapy; if there is a lack of previous experience with diabetes medication and monotherapy does not result in adequate blood sugar control, it can be combined with metformin. This medication is also used in conjunction with sulfonylureas, metformin, thiazolidinediones, or insulin when sufficient blood sugar control is not achieved with monotherapy. Furthermore, if blood sugar control is challenging even in more complex combination therapies, this medication may be added to enhance therapeutic efficacy. Thus, this medication is effectively used to improve blood sugar control in various circumstances.

How to take

Adult dose

The recommended dosage is 100 mg once daily, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with kidney impairment, dosage adjustments may not be necessary for mild and moderate kidney impairment (eGFR 45 or greater but less than 90). In moderate kidney impairment with an eGFR of 30 to less than 45, give 50 mg once daily.

Precautions

This medication may rarely cause serious allergic reactions; therefore, if symptoms such as rash or difficulty breathing occur within 3 months of starting therapy, it should be discontinued immediately and a physician consulted. This medication can induce a serious inflammation of the pancreas known as pancreatitis; thus, if symptoms such as abdominal pain, vomiting, or loss of appetite arise during therapy, medical personnel should be informed immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis and should not be used if there is hypersensitivity to this medication or any of its components. Patients with impaired kidney function may need dosage adjustments for this medication, so regular kidney function tests should be performed per the physician's directions. There is a risk of hypoglycemia during the use of this medication, so blood glucose should be carefully monitored, particularly when used in conjunction with insulin or sulfonylureas. If severe joint pain or blistering of the skin occurs, it is necessary to inform a physician immediately and discontinue the medication. This medication is not recommended for use in pregnant or breastfeeding women, and safety and effectiveness have not been established for children and adolescents under 18 years of age. Elderly patients may have decreased kidney function; thus, dosage adjustment and regular assessments of kidney function are important. In case of overdose, emergency measures such as removal of the drug from the gastrointestinal tract may be required, and some may be removed via hemodialysis, so instructions from medical personnel should be followed. While this medication has no significant interactions with many other drugs, blood concentration changes may occur with specific medications, and consultation with a physician is advised. If there are any unusual symptoms or discomfort during treatment, it is important to consult medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, rash, thrombocytopenia, Stevens-Johnson syndrome, exfoliative skin disease, bullous pemphigoid, acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute renal failure, severe allergic reactions

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • dyspepsia
  • dizziness
  • weight loss
  • hypertension
  • hypernatremia
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  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • myalgia
  • limb pain
  • back pain
  • pruritus

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

Storage

Store this medication in a tightly closed container that is air-tight, at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy for a longer time.

Appearance and packaging

Appearance

Pale yellowish pink, round, biconvex film-coated tablets

Package unit

30 tablets/box (10 tablets/PTP X 3)

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.