Medication info

Sitagliptin Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Pale orange, round, convex film-coated tablet
Packaging
28 tablets) 14 tablets/PPT (x2), 30 tablets) 10 tablets/PPT (x3)
Approval status
Expired

MFDS item code 202004107 · 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 in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dosage of 100 mg, whether as monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. This medication can be taken regardless of meals. In patients with renal impairment, dosage adjustments are necessary based on renal function. - In patients with mild renal impairment (eGFR 60–90 mL/min/1.73 m2), no dosage adjustment is required. - In patients with moderate renal impairment (eGFR 45–60 mL/min/

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement in 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 diet and exercise to help control blood sugar levels in patients with type 2 diabetes. Initially, it may be used as monotherapy, but if blood sugar control is difficult, it can be combined with metformin. Additionally, this medication can be added to improve efficacy when monotherapies such as sulfonylureas, metformin, thiazolidinediones, or insulin alone are insufficient. In cases of difficulty in blood sugar control despite complex combination therapy, this medication can be added to the treatment regimen. It is used to effectively improve blood sugar control.

How to take

Adult dose

This medication is administered once daily at a dosage of 100 mg, whether as monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. This medication can be taken regardless of meals. In patients with renal impairment, dosage adjustments are necessary based on renal function. - In patients with mild renal impairment (eGFR 60–90 mL/min/1.73 m2), no dosage adjustment is required. - In patients with moderate renal impairment (eGFR 45–60 mL/min/

Precautions

Rarely, this medication can cause serious allergic reactions, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, discontinue use immediately and consult a physician. This medication can cause acute pancreatitis, which is an inflammation of the pancreas, so if severe abdominal pain, nausea, or vomiting occurs, immediate medical attention is required. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should not be administered to those who have allergies to the drug or its components. In patients with impaired renal function, dosage adjustment is necessary, so individuals with kidney disease should inform their healthcare provider. While taking this medication, upper respiratory tract infections, headaches, dyspepsia, diarrhea, etc., may occur, and there is a possibility of hypoglycemic symptoms, so caution is warranted. Especially when taken in combination with insulin or sulfonylureas, the risk of hypoglycemia increases, so blood glucose levels should be checked frequently, and dosage adjustments may be needed. This medication has been reported to have rare side effects such as arthralgia or skin blistering; if such symptoms occur, inform a physician immediately. Use of this medication during pregnancy or lactation is not recommended, and safety has not been established in children under 18 years of age. Elderly patients may have a higher risk of renal function decline, so regular kidney function tests are advisable before and after taking this medication. In cases of overdose, gastrointestinal removal of the drug and appropriate monitoring such as ECG may be necessary, and some of the drug may be removed via hemodialysis. This medication generally has minimal drug interactions when combined with other hypoglycemic agents, but caution is needed when combined with certain medications, so it should be discussed with a physician or pharmacist.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • anaphylaxis
  • angioedema
  • severe allergic reactions
  • severe rashes
  • blisters
  • skin peeling
  • pain of oral/ocular mucosa
  • Stevens-Johnson syndrome
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  • acute pancreatitis
  • liver abnormalities (jaundice)
  • severe and disabling arthralgia
  • bullous pemphigoid
  • acute renal failure
  • rhabdomyolysis
  • cardiac arrest

Mild side effects

  • Rhinitis
  • upper respiratory tract infections
  • headaches
  • constipation
  • vomiting
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • abdominal pain
  • nausea
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in an airtight container to prevent air exposure, maintaining a storage temperature between 1 to 30 degrees Celsius. Proper storage will help retain the drug's efficacy.

Appearance and packaging

Appearance

Pale orange, round, convex film-coated tablet

Package unit

28 tablets) 14 tablets/PPT (x2), 30 tablets) 10 tablets/PPT (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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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.