Medication info

Janugliflozin 25 mg Tablet (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
Light orange, round, biconvex, film-coated tablet
Packaging
28 tablets/PtP [14 tablets/PtP * 2]
Approval status
Expired

MFDS item code 202004038 · 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
Who takes it
Adults
Adult dose
This medication is administered once daily at a dose of 100 mg as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Dose adjustments for patients with renal impairment: - Mild to moderate renal impairment (eGFR 45 or greater but less than 90): Dose adjustment not needed - Moderate renal impairment (eGFR 30 or greater but less than 45): 50 mg once daily - Severe

Ingredients

Manufacturer
영풍제약(주)

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 in conjunction with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone to newly diagnosed patients receiving initial diabetes medication treatment, and if monotherapy does not adequately control blood sugar levels, it can be used in combination with metformin. Furthermore, it is administered in combination when blood sugar control is difficult with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin. Therefore, this medication plays an important role in improving blood sugar control at various stages of treatment.

How to take

Adult dose

This medication is administered once daily at a dose of 100 mg as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Dose adjustments for patients with renal impairment: - Mild to moderate renal impairment (eGFR 45 or greater but less than 90): Dose adjustment not needed - Moderate renal impairment (eGFR 30 or greater but less than 45): 50 mg once daily - Severe

Precautions

This medicine can rarely cause severe allergic reactions; therefore, if symptoms such as skin rash or difficulty breathing occur, its use should be stopped immediately and medical consultation sought. Additionally, acute pancreatitis, which involves inflammation of the pancreas, may occur, so if abdominal pain, vomiting, or severe abdominal discomfort is felt, immediate medical attention is necessary. This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients allergic to any of the drug components. Patients with reduced kidney function may experience a slower excretion of the medication, requiring dose adjustments or cautious use, along with regular kidney function tests. When used with other diabetes medications or insulin that can cause hypoglycemia, close attention to hypoglycemic symptoms is advised, and dose adjustments of other medications may be necessary. During the use of this drug, symptoms such as headache, upper respiratory infection, pharyngitis, diarrhea, and nausea may occur, and if they are severe or persistent, medical consultation should be sought. The safety of this drug has not been established in pregnant or nursing women, and its use is not recommended in children or adolescents under 18 years of age. In the elderly, dose adjustments and kidney function monitoring are necessary as kidney function may decline. In case of overdose, immediate medical attention is necessary to receive appropriate treatment, and some medications can be removed via hemodialysis. This drug has relatively few interactions with other medications, but caution is required when taking certain medications, thus it is important to inform healthcare providers about all medications being taken. If severe joint pain or skin blistering occurs during treatment, discontinue the drug and seek evaluation from a specialist.

Side effects and when to seek care immediately

Serious side effects

Severe hypersensitivity reactions (including anaphylaxis, angioedema, Steven-Johnson syndrome, and exfoliative skin diseases), acute pancreatitis (including hemorrhagic or necrotizing), severe hypoglycemia, acute kidney failure (sometimes requiring dialysis), severe joint pain with disability, bullous pemphigoid, increased liver enzymes, liver abnormalities (including jaundice), pneumonia, diabetes complications, metabolic acidosis, falls, cardiac arrest, rhabdomyolysis, serious skin adverse reactions, severe

Mild side effects

  • Upper respiratory infection
  • pharyngitis
  • headache
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • vomiting
  • myalgia
  • limb pain
Show 12 more
  • back pain
  • pruritus
  • thrombocytopenia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia

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 exposure to air and moisture, and it is best to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Light orange, round, biconvex, film-coated tablet

Package unit

28 tablets/PtP [14 tablets/PtP * 2]

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.