Medication info
Sitagliptin 25mg Tablets (Sitagliptin Hydrochloride Monohydrate)

Sitagliptin 25mg Tablets (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.34mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Bright yellow-orange round film-coated tablets
Packaging
100 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202102016 · Approved 2021.03.04 · Insurance code 645605590

Summary

Main use
Improves blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered once daily at a dose of 100 mg, whether as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken without regard to meals. For patients with renal impairment, a daily dose of 50 mg is given for moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2). A daily dose of 25 mg is given for patients with severe renal impairment or end-stage renal disease (glomerular filtration rate below 15).

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improves blood glucose control in type 2 diabetes

  • Difficulty in blood glucose control in patients with type 2 diabetes
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This medication is used in conjunction with dietary and exercise therapy to help control blood glucose levels in patients with type 2 diabetes. It can be administered alone, but in some cases, it can be used in combination with other hypoglycemic agents such as metformin, sulfonylureas, thiazolidinediones, and insulin for more effective blood glucose control. It particularly helps improve blood glucose levels when monotherapy is insufficient. It is used for blood glucose control in type 2 diabetes with various treatment strategies alongside.

Dosage and Administration

Adult dosage

This medication is administered once daily at a dose of 100 mg, whether as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken without regard to meals. For patients with renal impairment, a daily dose of 50 mg is given for moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2). A daily dose of 25 mg is given for patients with severe renal impairment or end-stage renal disease (glomerular filtration rate below 15).

Precautions

This medication may cause severe allergic reactions; if symptoms such as skin rash or difficulty breathing occur after administration, it should be discontinued immediately, and a doctor should be consulted. Severe inflammation of the pancreas known as pancreatitis can occur, so if symptoms such as abdominal pain, vomiting, or nausea arise, stop taking this medication immediately and inform a healthcare provider. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor should it be taken by patients who are hypersensitive to this medication or its components. Patients with reduced kidney function may experience slower excretion of this medication, so it should be taken in a lower dosage, and kidney function tests should be performed regularly. During treatment, symptoms similar to a cold, headache, dyspepsia, and diarrhea may occur; consult a doctor if these symptoms persist or worsen. The risk of hypoglycemia increases when taken with other hypoglycemic agents, especially insulin or sulfonylureas, so blood glucose levels should be checked frequently and medication dosages adjusted as necessary. If severe or persistent joint pain occurs during treatment, it may be related to the medication, so consult a doctor to decide whether to discontinue it. Rarely, blistering similar to pemphigus may develop on the skin, so report any skin abnormalities to a healthcare provider immediately. The use of this medication in pregnant or breastfeeding women is not recommended, and its safety and efficacy have not been established in children under 18 years of age. In case of overdose, general treatment measures such as removal of the medication from the gastrointestinal tract are implemented, and, if necessary, hemodialysis can be used to remove the drug. This medication has a low potential for drug interactions, but it is important to consult a healthcare provider if taking other medications, especially for patients with heart or kidney disease.

Side effects and when to seek care immediately

Serious side effects

Severe hypersensitivity reactions (anaphylaxis, angioedema, hives, rash, skin vasculitis, Stevens-Johnson syndrome, exfoliative skin disease), acute pancreatitis (including hemorrhagic or necrotizing pancreatitis), acute renal failure (requiring dialysis), severe and disabling arthralgia, blistering similar to pemphigus, liver abnormalities (although jaundice-related symptoms have not been reported, elevated liver enzymes have been observed), serious neurological symptoms (such as severe headache, seizures, etc. have been reported)

Mild side effects

  • Upper respiratory infection
  • pharyngitis
  • headache
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • vomiting
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • hypoglycemia
  • dyspepsia
  • dizziness
  • elevated liver enzymes
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • 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 air and moisture from getting in, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablets

Package unit

100 tablets/bottle, 30 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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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.