Medication info
Janustin 100 mg (Sitagliptin Hydrochloride Hydrate)

Janustin 100 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.37mg / 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 202102721 · Approved 2021.03.29 · Insurance code 665003190

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered as a single dose of 100 mg once daily in either monotherapy or combination therapy, with a maximum daily dose of 100 mg. For patients with renal impairment, dosage adjustments are necessary based on kidney function. - Mild renal impairment patients (eGFR 60 to less than 90): No dosage adjustment needed - Moderate renal impairment patients (eGFR 45 to less than 60): No dosage adjustment needed - Moderate renal impairment patients (eGFR 30 to less than 45): 50 mg once daily.

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 help control blood sugar in patients with type 2 diabetes. It can be used as a monotherapy or as an adjunct to diet and exercise. It is administered in combination with metformin when monotherapy is insufficient for blood sugar control in patients without prior diabetes medication experience. Additionally, it can be added when adequate blood sugar control is not achieved with monotherapy of sulfonylurea, metformin, thiazolidinediones, or insulin. It can be used in adjunctive combination therapy to improve blood sugar control effectively.

Dosage and Administration

Adult dosage

This medication is administered as a single dose of 100 mg once daily in either monotherapy or combination therapy, with a maximum daily dose of 100 mg. For patients with renal impairment, dosage adjustments are necessary based on kidney function. - Mild renal impairment patients (eGFR 60 to less than 90): No dosage adjustment needed - Moderate renal impairment patients (eGFR 45 to less than 60): No dosage adjustment needed - Moderate renal impairment patients (eGFR 30 to less than 45): 50 mg once daily.

Precautions

This medication may cause serious allergic reactions; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or throat occur after taking the medication, discontinue use immediately and consult a physician. Patients should monitor closely for symptoms of pancreatitis, such as severe abdominal pain or vomiting, or persistent abdominal pain while taking this medication, and should discontinue use and inform healthcare personnel if such symptoms are suspected. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication, nor should it be used by those allergic to the drug or its components. Patients with reduced kidney function should take a reduced dose of this medication and undergo regular kidney function tests. In clinical trials, patients taking this medication reported side effects similar to cold and upper respiratory infections, headaches, nasopharyngitis, diarrhea, and nausea, along with some experiencing hypoglycemia. The risk of hypoglycemia may increase when this medication is taken in combination with other antidiabetic agents such as insulin or sulfonylureas, and blood sugar changes should be monitored closely. Patients may experience severe joint pain and should consult a physician and consider discontinuing the medication if symptoms occur. Additionally, rare instances of skin blisters or ulcers may occur, so patients should notify healthcare personnel immediately if any skin abnormalities arise. It is advised that pregnant or breastfeeding women avoid this medication, and safety and efficacy have not been established in individuals under the age of 18. Elderly patients may require dose adjustments and regular kidney function tests due to potential declines in kidney function. In the case of overdose, emergency treatment such as the removal of the drug from the gastrointestinal tract may be necessary, and blood dialysis could be considered as this medication can be partially removed by hemodialysis if necessary. Though interactions with other medications are limited, caution is advised when taken with digoxin or cyclosporine; therefore, consultation with healthcare personnel during usage is important.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, severe skin adverse reactions (including Stevens-Johnson syndrome, exfoliative dermatitis, rash), acute pancreatitis, acute renal failure, severe and disabling arthralgia, bullous pemphigoid, cardiac arrest, pneumonia, diabetes complications, metabolic acidosis, serious allergic reactions, severe hypoglycemia

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • increased 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 or moisture exposure, and it is best kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for 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.