Medication info

Sitagliptin 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Pale yellowish pink round biconvex film-coated tablet
Packaging
28 tablets) 14 tablets/PTP(x2), 30 tablets) 10 tablets/PTP(x3)
Approval status
Expired

MFDS item code 202004105 · 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 for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (eGFR 60 to < 90): No dosage adjustment required. - Moderate renal impairment (eGFR 45 to < 60): No dosage adjustment required. - Moderate renal impairment

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
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 administered alone or in combination with metformin in those receiving initial treatment for diabetes. If blood sugar control is difficult with monotherapy of sulfonylurea, metformin, thiazolidinedione, or insulin, this medication can be added as an adjunct. It aids in blood sugar management when combination therapy is necessary. Thus, it effectively improves blood sugar control in patients with type 2 diabetes when used alongside various therapeutic approaches.

How to take

Adult dose

This medication is administered once daily at a dose of 100 mg for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (eGFR 60 to < 90): No dosage adjustment required. - Moderate renal impairment (eGFR 45 to < 60): No dosage adjustment required. - Moderate renal impairment

Precautions

This medication may rarely cause severe allergic reactions after administration; therefore, if symptoms such as rash, difficulty breathing, swelling of the face or tongue occur, usage should be discontinued immediately and consultation with a physician should be sought. This medication may induce serious inflammation of the pancreas (pancreatitis); if symptoms such as abdominal pain, vomiting, or loss of appetite appear, immediate medical attention is required. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should not be administered if there is an allergy to this medication or its components. Patients with impaired kidney function may have delayed excretion of this medication, necessitating dosage adjustments and regular monitoring of kidney function. The risk of hypoglycemia may increase when used with other hypoglycemic agents, especially insulin or sulfonylureas; thus, attention to hypoglycemia symptoms and dosage adjustments of other medications may be needed. If severe joint pain or blistering skin conditions occur during treatment, immediate consultation with a physician is recommended and consideration for discontinuing the medication may be warranted. This medication is not recommended for use during pregnancy, and nursing mothers should also avoid taking it. Safety and efficacy in children and adolescents have not been established; therefore, it is preferable not to use it in these populations. Elderly patients are at higher risk for impaired renal function, so periodic assessment of kidney function before and during treatment is recommended. In case of overdose, general symptomatic treatment should be undertaken, and consideration may be given to blood dialysis for drug removal if necessary. This medication has fewer interactions with other drugs, but caution is advised when used with digoxin or cyclosporine, and medical guidance should be followed.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • acute kidney injury
  • severe hypoglycemia
  • severe joint pain with disability
  • blistering pemphigoid
  • pneumonia
Show 4 more
  • diabetic complications
  • metabolic acidosis
  • falls
  • cardiac arrest

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • diarrhea
  • abdominal pain
  • nausea
  • constipation
  • vomiting
  • myalgia
  • limb pain
Show 11 more
  • back pain
  • pruritus
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • gastritis
  • 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 ingress. It is recommended to store at room temperature between 1°C and 30°C to maintain the effectiveness of the drug for a longer duration.

Appearance and packaging

Appearance

Pale yellowish pink round biconvex film-coated tablet

Package unit

28 tablets) 14 tablets/PTP(x2), 30 tablets) 10 tablets/PTP(x3)

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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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.