Medication info

Sitagliptin 25 mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›32.125mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Pink, round, biconvex film-coated tablet
Packaging
100 tablets/box [(10 tablets/PTP × 10)]
Approval status
Expired

MFDS item code 201502260 · Approved 2015.04.15

This product's status changed to Expired on 2025.04.15. 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 medication is administered once daily at a dose of 100 mg as monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. Patients with renal impairment may require dosage adjustment based on kidney function. In patients with mild to moderate renal impairment (eGFR 45-90 mL/min/1.73 m2), dosage adjustment is not necessary. In patients with moderate renal impairment (eGFR 30-45 mL/min/1.73 m2), the dose is 50 mg once daily.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Difficulty in blood glucose control in patients with type 2 diabetes
View approved original text

This medication is used in conjunction with diet and exercise to improve blood glucose control in patients with type 2 diabetes. It can be administered as monotherapy and is applicable to patients new to treatment. If blood glucose control is difficult with monotherapy, it may be combined with metformin. Additionally, when sufficient blood glucose control cannot be achieved with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this medication can be added to enhance efficacy. In cases of insufficient blood glucose control with multiple drug combinations, this medication can be used additionally to assist in blood glucose management. Thus, it effectively improves blood glucose control in patients with type 2 diabetes.

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 dosage of 100 mg. Patients with renal impairment may require dosage adjustment based on kidney function. In patients with mild to moderate renal impairment (eGFR 45-90 mL/min/1.73 m2), dosage adjustment is not necessary. In patients with moderate renal impairment (eGFR 30-45 mL/min/1.73 m2), the dose is 50 mg once daily.

Precautions

This medication is used for the treatment of diabetes, and serious allergic reactions may occur in some patients. Such allergic reactions can occur within three months of taking the medication, so caution is advised. There is a possibility of pancreatitis causing inflammation of the pancreas while taking this medication. If symptoms such as abdominal pain or vomiting occur, consult a doctor immediately. It is recommended not to use this medication in patients with type 1 diabetes or diabetic ketoacidosis. Additionally, it should be avoided by those who are allergic to this medication or its ingredients. Patients with poor kidney function need to adjust the dosage of this medication, and those undergoing dialysis should use caution. While taking this medication, side effects such as upper respiratory tract infections, headaches, dyspepsia, diarrhea, nausea, constipation, muscle pain, limb pain, back pain, itching, thrombocytopenia, dyspepsia, dizziness, increased blood triglycerides, elevated low-density lipoproteins, hyperglycemia, weight loss, hypernatremia, and erectile dysfunction may occur. In particular, the risk of hypoglycemia may increase when taken with other hypoglycemic agents such as insulin or sulfonylureas, so dosage adjustments may be necessary. Severe side effects such as severe joint pain or blistering conditions resembling bullous pemphigoid have been rarely reported; if such symptoms occur, consult a doctor immediately and discontinue use. Women who are pregnant or breastfeeding are advised not to take this medication, and it has not been established for safety and efficacy in children under 18 years of age. Elderly patients may have decreased kidney function, so kidney function tests are necessary before and during the use of this medication. In case of overdose, some of the medication may be removed through dialysis along with general treatment, so if overdose is suspected, seek medical attention immediately. This medication has relatively few drug interactions, but caution is required when taken with specific medications, so consult with a doctor or pharmacist.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, cutaneous vasculitis, exfoliative skin disorders such as Stevens-Johnson syndrome, acute pancreatitis, severe allergic reactions, acute renal failure, severe pain in the joints with disabilities, bullous pemphigoid, rhabdomyolysis

Mild side effects

  • Upper respiratory infections
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
  • itching
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoproteins
  • hyperglycemia
  • weight loss
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. Proper storage will ensure the effectiveness of the medication.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP × 10)]

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.