Medication info

Janusitin Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Light orange, round, biconvex film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP*2], 30 tablets/box [10 tablets/PTP*3]
Approval status
Expired

MFDS item code 202004058 · 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 glucose control in type 2 diabetes mellitus
Who takes it
Adults
Adult dose
The recommended dose for this medication is 100 mg once daily either as monotherapy or in combination therapy, and the maximum daily dose is 100 mg. It can be taken regardless of meals. Patients with kidney impairment need dosage adjustments based on kidney function: - Mild kidney impairment (eGFR 60-90) does not require dose adjustment. - Moderate kidney impairment (eGFR 45-60) does not require dose adjustment. - Moderate kidney impairment (eGFR 30-<45)

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes mellitus

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

This medication is used in conjunction with diet and exercise to help control blood sugar in patients with type 2 diabetes. It can be taken alone, and for patients who have not previously used diabetes medications, it can be administered in combination with metformin when monotherapy is not sufficient. Additionally, it can be taken alongside sulfonylureas, metformin, thiazolidinediones, and insulin when blood sugar control is difficult with these monotherapies. In cases where blood sugar control is inadequate while undergoing combination therapy with various medications, this medication can be added to improve blood glucose management. It is used effectively for blood glucose control in diverse situations.

How to take

Adult dose

The recommended dose for this medication is 100 mg once daily either as monotherapy or in combination therapy, and the maximum daily dose is 100 mg. It can be taken regardless of meals. Patients with kidney impairment need dosage adjustments based on kidney function: - Mild kidney impairment (eGFR 60-90) does not require dose adjustment. - Moderate kidney impairment (eGFR 45-60) does not require dose adjustment. - Moderate kidney impairment (eGFR 30-<45)

Precautions

This medication can cause rare but serious allergic reactions, so if symptoms such as skin rash or breathing difficulties occur, usage should be immediately stopped and a doctor should be consulted. During the use of this medication, symptoms of acute pancreatitis such as abdominal pain, vomiting, and nausea may occur, so inform healthcare professionals if these symptoms arise. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should not be administered to individuals who have an allergy to this drug or any of its components. Patients with impaired kidney function must adjust their dosage of this medication, so it is advised to have regular kidney function tests and to follow a doctor’s instructions. When taken with other blood glucose-lowering medications, especially insulin or sulfonylureas, the risk of hypoglycemia may increase, so blood glucose levels should be monitored regularly, and attention should be paid to symptoms of hypoglycemia. If symptoms such as joint pain or blisters on the skin occur during treatment, notify a doctor immediately, and medication may need to be discontinued if necessary. It is recommended that pregnant or breastfeeding women avoid using this medication, and safety in children and adolescents under 18 has not been established. Elderly patients may experience reduced kidney function, therefore it is necessary to evaluate kidney function before taking this medication and to monitor it periodically. In case of overdose, gastric decontamination should be carried out and the condition should be monitored via electrocardiograms, and blood dialysis may be considered if necessary. This medication has low interactions with metformin, rosiglitazone, simvastatin, and warfarin but caution is needed when used in combination with specific drugs. Long-term use of this medication may result in liver dysfunction, blood disorders, gastrointestinal symptoms, headaches, infections, and other side effects, so regular health check-ups are necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, Stevens-Johnson syndrome, exfoliative skin conditions, acute pancreatitis (including hemorrhagic or necrotizing pancreatitis), acute renal failure, severe joint pain with disability, bullous pemphigoid, rhabdomyolysis, pneumonia, diabetic complications, metabolic acidosis, falls, cardiac arrest

Mild side effects

  • Rhinitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • elevated low-density lipoprotein
  • hyperglycemia
  • 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 a tightly sealed container to prevent air and moisture from entering. It is best to keep the storage temperature at room temperature between 1 and 30 degrees Celsius. Avoid storing it in areas that are too hot or too cold.

Appearance and packaging

Appearance

Light orange, round, biconvex film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP*2], 30 tablets/box [10 tablets/PTP*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.