Medication info
Janusitin Tablets 25 mg (Sitagliptin Hydrochloride Hydrate)

Janusitin Tablets 25 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.34mg / 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 202102720 · Approved 2021.03.29 · Insurance code 665003180

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
The recommended dosage of this drug is 100 mg once daily for both monotherapy and combination therapy, with a maximum daily dosage of 100 mg. This drug can be taken regardless of meals. Dosage adjustment for patients with renal impairment: - For mild and moderate renal impairment (glomerular filtration rate 45 or more but less than 90), no dosage adjustment is necessary. - For patients with moderate renal impairment with a glomerular filtration rate of 30 or more but less than 45, the dose is 50 mg once daily.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This drug is used in conjunction with dietary management and exercise therapy to improve blood sugar control in patients with type 2 diabetes. It can be administered alone or in combination with metformin for patients who have not previously been treated for diabetes and find it difficult to control blood sugar with monotherapy. Additionally, this drug is used in combination when adequate control is not achieved with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin. This drug also helps control blood sugar when blood sugar control is insufficient in combination therapy with multiple medications. In summary, this drug is used to enhance blood sugar control in various monotherapy and combination therapy.

Dosage and Administration

Adult dosage

The recommended dosage of this drug is 100 mg once daily for both monotherapy and combination therapy, with a maximum daily dosage of 100 mg. This drug can be taken regardless of meals. Dosage adjustment for patients with renal impairment: - For mild and moderate renal impairment (glomerular filtration rate 45 or more but less than 90), no dosage adjustment is necessary. - For patients with moderate renal impairment with a glomerular filtration rate of 30 or more but less than 45, the dose is 50 mg once daily.

Precautions

This drug may cause severe allergic reactions after administration, so if symptoms like skin rash or difficulty in breathing occur, stop taking it immediately and consult a healthcare professional. Furthermore, serious inflammation of the pancreas known as pancreatitis may occur, so if symptoms such as abdominal pain or vomiting appear, you should go to the hospital immediately. This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should be avoided in cases of hypersensitivity to this drug or its components. Patients with impaired renal function should have their dosage adjusted; therefore, they should take it according to their doctor's instructions. When used in combination with other hypoglycemic agents like insulin or sulfonylureas, the risk of hypoglycemia may increase, so blood sugar levels should be checked regularly. If severe joint pain or blisters appear during treatment, inform your doctor immediately and discontinue the medication. Women who are pregnant or breastfeeding should preferably avoid taking this drug, and its safety and efficacy have not been established for children under 18 years of age. In elderly patients, renal function may decline, so it is important to undergo renal function tests before administration and to take it carefully. In case of overdose, immediate medical attention should be sought and appropriate treatment should be provided, as this drug can be partially removed by hemodialysis. It is important to consult your doctor or pharmacist when taking this drug with other medications due to the possibility of interactions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, severe hypersensitivity reactions, exfoliative skin disorders including Stevens-Johnson syndrome, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, acute pancreatitis, acute renal failure, severe edema, cardiac arrest, pneumonia, severe allergic reactions, severe skin adverse reactions, worsening renal function, severe and disabling arthralgia, bullous pemphigoid, rhabdomyolysis

Mild side effects

  • Hypoglycemia
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • peripheral edema
Show 18 more
  • myalgia
  • limb pain
  • back pain
  • interstitial lung disease
  • pruritus
  • thrombocytopenia
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • dyspepsia
  • dizziness
  • increased ALT
  • increased AST
  • gastritis
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This drug should be stored in a tightly closed container that is airtight, and it is important to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the efficacy of the drug and prevent deterioration.

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.