Medication info

Sitax XR 25 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.345mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Pink, round, film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202007522 · Approved 2020.11.03

This product's status changed to Approval withdrawn on 2025.05.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This drug is administered at a dosage of 100 mg once daily, either as monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments may not be needed for mild and moderate renal impairment. In moderate renal impairment (glomerular filtration rate of 30-45 mL/min/1.73 m²), 50 mg is administered once daily.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Blood glucose control issues in type 2 diabetes patients
View approved original text

This drug is used to enhance blood glucose control in patients with type 2 diabetes alongside dietary and exercise therapies. It can be administered alone or in combination with other medications to improve therapeutic effects. This helps patients manage their blood glucose levels more effectively.

How to take

Adult dose

This drug is administered at a dosage of 100 mg once daily, either as monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments may not be needed for mild and moderate renal impairment. In moderate renal impairment (glomerular filtration rate of 30-45 mL/min/1.73 m²), 50 mg is administered once daily.

Precautions

This medication may cause severe allergic reactions; if symptoms such as rash or difficulty breathing occur, discontinue use immediately and consult a physician. During treatment, there is a risk of developing severe pancreatitis; therefore, if experiencing symptoms such as abdominal pain, vomiting, or fever, immediately inform healthcare personnel. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication, and those with allergies to this drug or its components should avoid it. Patients with reduced kidney function may require dosage adjustments, and appropriate dosages should be determined through kidney function tests. While taking this medication, side effects such as cold-like symptoms, headaches, indigestion, and diarrhea may occur; if symptoms are severe, consult healthcare personnel. When taken with other glucose-lowering agents or insulin, there is an increased risk of hypoglycemia; appropriate measures should be taken if hypoglycemic symptoms appear. This drug can cause severe joint pain or blistering skin conditions; if these symptoms occur, discontinue usage immediately and consult a physician. Pregnant or breastfeeding women are advised not to take this medication, and safety in children under 18 has not been established. Elderly patients may experience reduced kidney function, so regular monitoring of kidney function before and after taking this drug is recommended. In case of overdose, general treatments such as removing the drug from the gastrointestinal tract are implemented, and some medications may be removed through hemodialysis.

Side effects and when to seek care immediately

Serious side effects

Severe hypersensitivity reactions (including urticaria and angioedema), anaphylaxis, exfoliative skin diseases (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, severe and disabling joint pain, vesicular pemphigoid, rhabdomyolysis, pneumonia, cardiac arrest, angioedema

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • headache
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • vomiting
  • muscle pain
  • limb pain
Show 12 more
  • back pain
  • pruritus
  • thrombocytopenia
  • indigestion
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoproteins
  • 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 sealed container to prevent air and moisture from entering. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Pink, round, film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2), 30 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.