Medication info
Sitagliptin 100 mg (Sitagliptin Hydrochloride Monohydrate)

Sitagliptin 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Light brown, round, bilaterally convex, film-coated tablet
Packaging
28 tablets/box [14 tablets/PTPX2]
Approval status
Active

MFDS item code 202101405 · Approved 2021.02.18 · Insurance code 657807920

Summary

Main use
Improvement in blood glucose control in type 2 diabetes mellitus
Who uses it
Adults
Adult dosage
This medication is administered once daily at a dose of 100 mg, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. In patients with renal impairment, no dosage adjustment is needed for mild to moderate renal impairment. For patients with moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2), the dose is 50 mg once daily. For patients with severe renal impairment (glomerular filtration rate 15-30 mL/min/1.73 m2) or end-stage renal disease requiring dialysis or peritoneal dialysis (glomerular filtration rate < 15 mL/min/1.73 m2), the dose is 25 mg once daily.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement in blood glucose control in type 2 diabetes mellitus

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

This medication is used to help control blood glucose levels in patients with type 2 diabetes. It can be administered alone or in combination with metformin when blood glucose control is insufficient with existing diabetes treatments, alongside dietary therapy and exercise. Additionally, it can be used in combination with sulfonylureas, thiazolidinediones, and insulin when blood glucose control is also difficult alone or in combination therapy, enhancing therapeutic efficacy. Therefore, this medication is used to improve blood glucose control in various treatment situations.

Dosage and Administration

Adult dosage

This medication is administered once daily at a dose of 100 mg, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. In patients with renal impairment, no dosage adjustment is needed for mild to moderate renal impairment. For patients with moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2), the dose is 50 mg once daily. For patients with severe renal impairment (glomerular filtration rate 15-30 mL/min/1.73 m2) or end-stage renal disease requiring dialysis or peritoneal dialysis (glomerular filtration rate < 15 mL/min/1.73 m2), the dose is 25 mg once daily.

Precautions

This medication can cause severe allergic reactions; therefore, if symptoms such as skin rash, difficulty in breathing, or swelling of the face or neck occur after use, discontinue use immediately and seek medical attention. During the course of this medication, severe inflammation of the pancreas (pancreatitis) may occur, so if symptoms such as abdominal pain, vomiting, or fever develop, notify healthcare personnel immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should also be avoided by those with a severe allergic reaction to this medication or its components. Patients with decreased kidney function may require dosage adjustments and should undergo regular kidney function tests. During treatment, symptoms similar to cold, headache, dyspepsia, diarrhea, etc. may occur, and hypoglycemic symptoms may also appear, so blood glucose levels should be monitored closely. When taken in combination with insulin or other hypoglycemic agents, the risk of hypoglycemia may increase, so dosage adjustments for hypoglycemic agents may be necessary. This medication is not recommended for use during pregnancy and should be avoided while breastfeeding. The safety and efficacy of this medication have not been fully established in individuals under 18 years of age. Elderly patients are at risk of decreased kidney function, so it is important to evaluate kidney function before administration and to check periodically during treatment. In case of overdose, seek medical help immediately for appropriate treatment; some drugs may be removed by hemodialysis. This medication can interact with certain drugs, therefore be sure to inform healthcare personnel if you are taking other medications. Also, if severe joint pain or blistering skin symptoms occur while taking this medication, consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, exfoliative skin diseases such as Stevens-Johnson syndrome, severe skin adverse reactions, acute pancreatitis, severe allergic reactions, joint pain accompanied by severe symptoms or disability, blistering dermatosis, liver abnormalities (elevated liver enzyme levels), acute renal failure, rhabdomyolysis, serious neurological symptoms are not specified but require caution.

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • abdominal pain
  • nausea
  • hypoglycemia
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • gastritis
  • 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 tightly sealed container to prevent exposure to air and moisture. It is recommended to maintain storage temperature at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Light brown, round, bilaterally convex, film-coated tablet

Package unit

28 tablets/box [14 tablets/PTPX2]

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.