Medication info

Sitagliptin 100 mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTabletExpired
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
Beige, round, double-sided convex film-coated tablet
Packaging
30 tablets/bottle, 90 tablets/bottle
Approval status
Expired

MFDS item code 202008323 · Approved 2020.11.30

This product's status changed to Expired on 2025.11.30. 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 uses it
Adults
Adult dosage
This drug is administered once daily at 100 mg as monotherapy or in combination therapy, and the maximum daily dose is 100 mg. This drug can be taken without regard to meals. Renal impairment dosage adjustment: - In mild and moderate renal impairment (eGFR 45 or greater but less than 90), dose adjustment is not required. - In moderate renal impairment (eGFR 30 or greater but less than 45), 50 mg once daily.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Improvement of blood sugar control in Type 2 diabetes

  • Type 2 diabetes
  • blood sugar control disorder
View approved original text

This drug is used as an adjunct to improve blood sugar control in patients with Type 2 diabetes in combination with dietary therapy and physical activity. Patients without prior experience in diabetes treatment may take this drug alone. If blood sugar control is difficult, it can be taken with metformin and is also effective when combined with other diabetes medications such as sulfonylureas, thiazolidinediones, and insulin. If various combination therapies are insufficient for blood sugar control, this drug can be added to aid in blood sugar improvement. This drug is utilized as monotherapy or in combination therapy tailored to the individual patient's treatment situation, effectively improving blood sugar control.

Dosage and Administration

Adult dosage

This drug is administered once daily at 100 mg as monotherapy or in combination therapy, and the maximum daily dose is 100 mg. This drug can be taken without regard to meals. Renal impairment dosage adjustment: - In mild and moderate renal impairment (eGFR 45 or greater but less than 90), dose adjustment is not required. - In moderate renal impairment (eGFR 30 or greater but less than 45), 50 mg once daily.

Precautions

This drug may rarely cause severe allergic reactions; if symptoms such as rash, itching, or difficulty breathing occur, discontinue use immediately and consult a physician. While taking this drug, symptoms of pancreatitis, which indicates inflammation of the pancreas, may appear; inform medical personnel immediately if you experience abdominal pain, vomiting, or severe abdominal discomfort. Do not take this drug if you are a patient with Type 1 diabetes or diabetic ketoacidosis. Patients who have had an allergic reaction to this drug or its components should not take it. Patients with impaired renal function should adjust the dose of this drug, and regular kidney function tests are important. During treatment, you may experience cold-like symptoms, headache, indigestion, diarrhea, etc.; if symptoms persist or worsen, consult a physician. If taken together with other blood-glucose-lowering agents such as insulin or sulfonylureas, hypoglycemia may occur, so blood sugar levels should be checked frequently, and the dose of those medications should be adjusted if necessary. This drug is not recommended for pregnant or breastfeeding women, and safety and efficacy in children under 18 years have not been established. Elderly patients may have decreased renal function, so it is advisable to check kidney function before and after taking the drug. In case of overdose, visit a healthcare institution immediately for appropriate action; some of the drug may be removed via hemodialysis. If you develop blisters or severe itching on the skin while taking this drug, inform a physician immediately, and if necessary, the medication may be discontinued. There are few interactions with other medications, but it is safe to consult with a physician or pharmacist when taking specific medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, rash, severe allergic reaction, Stevens-Johnson syndrome and exfoliative skin diseases, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, acute pancreatitis (including hemorrhagic or necrotizing pancreatitis), severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), acute renal failure, serious neurological symptoms, severe

Mild side effects

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

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

Storage

This drug should be stored in a tightly sealed container to prevent air and moisture. Moreover, it is advisable to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Beige, round, double-sided convex film-coated tablet

Package unit

30 tablets/bottle, 90 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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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.