Medication info

Sitagliptin 25 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTabletExpired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Pink, round, biconvex film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP x 2]
Approval status
Expired

MFDS item code 202101001 · Approved 2021.02.02

This product's status changed to Expired on 2026.02.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood glucose control for type 2 diabetes
Who uses it
Adults
Adult dosage
The usual dosage is 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken with or without food. In cases of renal impairment, dosage adjustments are necessary according to renal function. - In moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2), the dosage is 50 mg once daily. - In severe renal impairment (glomerular filtration rate 15-30 mL/min/1.73 m2), the dosage is 25 mg once daily.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Improvement in blood glucose control for type 2 diabetes

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

This medication is used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. It can be administered as monotherapy, and for patients who have not previously received diabetes pharmacotherapy and find sufficient glycemic control difficult with monotherapy, it is administered in combination with metformin. Additionally, when glycemic control is difficult with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin, this medication is administered to assist in glycemic management. Even in cases involving multiple medications, adding this medication can be expected to enhance glycemic control effects. This medication is also useful in improving glycemic control in complex treatment scenarios.

Dosage and Administration

Adult dosage

The usual dosage is 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken with or without food. In cases of renal impairment, dosage adjustments are necessary according to renal function. - In moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2), the dosage is 50 mg once daily. - In severe renal impairment (glomerular filtration rate 15-30 mL/min/1.73 m2), the dosage is 25 mg once daily.

Precautions

This medication may cause allergic reactions, so if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and consult a physician. During the use of this medication, if symptoms of pancreatitis such as abdominal pain, nausea, or vomiting occur, inform medical personnel immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis. Patients with impaired renal function need dosage adjustments, so regular kidney function tests are required. When taken with other hypoglycemic agents, especially insulin or sulfonylureas, the risk of hypoglycemia may increase, so blood glucose levels should be monitored closely. If severe joint pain or skin blisters appear during treatment with this medication, inform a physician immediately, and discontinue use if necessary. Pregnant or lactating women should not take this medication, and safety in children under 18 has not been established. Elderly patients may have reduced renal function, necessitating dosage adjustments and kidney function testing. In cases of overdose, seek proper treatment at a medical facility immediately, as this medication can be partially removed by hemodialysis. This medication has minimal interactions with other drugs, but it is important to inform medical personnel when taking certain medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, severe allergic reactions, Stevens-Johnson syndrome and exfoliative skin diseases, severe skin adverse reactions, acute pancreatitis (fatal/non-fatal hemorrhagic or necrotizing), worsening renal function (including acute renal failure), severe and disabling arthralgia, bullous pemphigoid, severe hypoglycemia, liver abnormalities (elevated liver enzymes), cardiac arrest, pneumonia, diabetic complications, metabolic acidosis, fall

Mild side effects

  • Rhinitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • hypertension
  • hypernatremia
  • erectile dysfunction
  • weight loss

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture infiltration. It should be kept at room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablets

Package unit

28 tablets/box [14 tablets/PTP x 2]

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.