Medication info
Janusitin Tablet 50 mg (Sitagliptin Hydrochloride Hydrate)

Janusitin Tablet 50 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Bright yellow-orange round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle - 30 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 202102719 · Approved 2021.03.29 · Insurance code 665003170

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered as 100 mg once daily, whether as monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with kidney impairment, dosage adjustments are necessary for those with mild to moderate kidney impairment (eGFR 45 to < 90), no dosage adjustment is needed. For patients with moderate kidney impairment (eGFR 30 to < 45), the dose is administered as 50 mg once daily. For patients with severe kidney impairment (

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control 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 in conjunction with diet and exercise. It can be administered as a monotherapy, and if adequate blood sugar control is difficult as monotherapy in patients without previous experience of diabetes medication, it is used in combination with metformin. Additionally, if blood sugar control is challenging with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this drug can be added as a combination therapy. It actively helps in blood sugar control when there is insufficient effect with various combination therapies. Therefore, it improves blood sugar control tailored to various situations and is effectively used in the treatment of type 2 diabetes.

Dosage and Administration

Adult dosage

This medication is administered as 100 mg once daily, whether as monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with kidney impairment, dosage adjustments are necessary for those with mild to moderate kidney impairment (eGFR 45 to < 90), no dosage adjustment is needed. For patients with moderate kidney impairment (eGFR 30 to < 45), the dose is administered as 50 mg once daily. For patients with severe kidney impairment (

Precautions

This medication can cause severe allergic reactions, therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after taking the drug, stop taking it immediately and consult a doctor. Severe inflammatory pancreatitis may occur during the use of this medication; if symptoms such as abdominal pain, nausea, or vomiting appear, contact healthcare professionals immediately. Patients with type 1 diabetes or diabetic ketoacidosis should not take this medication, and it should also not be taken by those who are allergic to this medication or its components. Patients with impaired kidney function need to adjust the dosage of this medication, and those with severely impaired kidney function need to exercise additional caution. Light adverse reactions such as cold symptoms, headache, rhinitis may occur during the course of this medication, and hypoglycemia may also occur, so it is essential to manage blood sugar carefully. This medication increases the risk of hypoglycemia when taken with other hypoglycemic agents, particularly insulin or sulfonylureas, so dosage adjustments may be necessary in these cases. If symptoms such as severe joint pain or blisters on the skin occur during the use of this medication, consult a physician immediately and stop taking the drug. Use of this medication is not recommended for pregnant or breastfeeding women, and safety in children under 18 years of age has not been established. Elderly patients may experience decreased kidney function more easily, so it is advisable to undergo kidney function tests before starting this medication and to monitor kidney function regularly. In the case of overdose, emergency treatment such as removing the drug from the gastrointestinal tract may be necessary, and this medication can be partially removed through dialysis if needed.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, anaphylaxis, severe allergic reactions
  • Acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis
  • Acute renal failure (sometimes requiring dialysis)
  • Severe joint pain accompanied by disability
  • Bullous pemphigoid
  • Elevated liver enzymes, liver abnormalities (including jaundice)
  • Severe hypoglycemia
  • Cardiac arrest
  • Pneumonia
  • Diabetes complications
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  • Metabolic acidosis
  • Falls

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • nausea
  • diarrhea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoproteins
  • hyperglycemia
  • weight loss
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication should be stored in a sealed container to prevent air ingress and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication over a longer period.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle - 30 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle - 100 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.