Medication info

Janusitin Tablet 25mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Light orange, round, bilaterally convex film-coated tablet
Packaging
28 tablets/box [(14 tablets/PVC*2)], 30 tablets/box [(10 tablets/PVC*3)]
Approval status
Expired

MFDS item code 202004057 · Approved 2020.05.29

This product's status changed to Expired on 2025.05.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes mellitus
Who takes it
Adults
Adult dose
For monotherapy or combination therapy, the usual dose is 100mg once daily, with a maximum daily dose of 100mg. In patients with renal impairment, dosage adjustment may be needed based on renal function. For mild to moderate renal impairment (eGFR 45-90 mL/min/1.73m2), no dosage adjustment is necessary. For moderate renal impairment (eGFR 30-45 mL/min/1.73m2), the recommended dose is 50mg once daily.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes mellitus

  • Difficulty in controlling blood sugar levels in patients with type 2 diabetes
View approved original text

This medication is used to improve blood sugar control in patients with type 2 diabetes. It may be administered alone as an adjunct to dietary and exercise therapy. If there has been no prior experience with diabetes medication and blood sugar control is difficult with monotherapy, it should be used in combination with metformin. Additionally, this drug helps effectively manage blood sugar when sufficient control is not achievable with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin. It is also used reliably to improve blood sugar control in situations requiring combination therapy.

How to take

Adult dose

For monotherapy or combination therapy, the usual dose is 100mg once daily, with a maximum daily dose of 100mg. In patients with renal impairment, dosage adjustment may be needed based on renal function. For mild to moderate renal impairment (eGFR 45-90 mL/min/1.73m2), no dosage adjustment is necessary. For moderate renal impairment (eGFR 30-45 mL/min/1.73m2), the recommended dose is 50mg once daily.

Precautions

This medication can occasionally cause serious allergic reactions; therefore, if symptoms such as skin rash or difficulty breathing occur, the medication should be stopped immediately and a doctor should be consulted. There is also a risk of acute pancreatitis, which is inflammation of the pancreas; thus, if symptoms such as abdominal pain, vomiting, or loss of appetite appear during treatment, medical consultation should be sought immediately. This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should be avoided in cases of hypersensitivity to the drug or its components. Patients with impaired renal function may require dosage adjustments due to slower excretion of the drug, and regular kidney function evaluations before and during treatment are important. Hypoglycemic symptoms may occur when using this drug, especially when combined with insulin or sulfonylurea, so blood sugar levels should be monitored closely and dosage adjustments may be necessary for those medications. If severe joint pain or blistering of the skin occurs, consult a physician immediately, and the medication may need to be discontinued in such cases. Use in pregnant or breastfeeding women is not recommended, and safety and efficacy have not been established in children under 18 years old. Elderly patients should use this drug with caution due to the potential for impaired renal function, and regular kidney function tests are required. In case of overdose, general treatment should be implemented, including removal of the drug from the gastrointestinal tract and monitoring of electrocardiograms, and some drugs may be removed via hemodialysis. This medication may interact with other diabetes treatments or certain medications, so it is important to inform your doctor or pharmacist of any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, exfoliative skin disorders (including Stevens-Johnson syndrome), acute pancreatitis, severe hypoglycemia, acute renal failure, severe and disabling arthralgia, blistering dermatitis, pneumonia, diabetes complications, metabolic acidosis, falls, cardiac arrest

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • dyspepsia
  • nausea
  • diarrhea
  • constipation
  • myalgia
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • increased triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • dizziness
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication should be stored in an airtight container, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness.

Appearance and packaging

Appearance

Light orange, round, bilaterally convex film-coated tablet

Package unit

28 tablets/box [(14 tablets/PVC*2)], 30 tablets/box [(10 tablets/PVC*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.

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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.