Medication info
Sitagliptin 25 mg (Sitagliptin Hydrochloride Hydrate)

Sitagliptin 25 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pink, round, biconvex film-coated tablet
Packaging
28 tablets/box [14 tablets/PTPX2]
Approval status
Active

MFDS item code 202101406 · Approved 2021.02.18 · Insurance code 657807930

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered as a single dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (glomerular filtration rate 60 or more but less than 90): No dosage adjustment required. - Moderate renal impairment (glomerular filtration rate 45 or more but less than 60): No dosage adjustment required. - Moderate renal impairment

Ingredients

Manufacturer
하나제약(주)

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 along with dietary therapy and exercise to help control blood sugar levels in patients with type 2 diabetes. It can be used alone when starting drug therapy for the first time. If blood sugar control is difficult with monotherapy, it can be combined with metformin. Additionally, if blood sugar is insufficiently controlled with monotherapies such as sulfonylureas, metformin, thiazolidinediones, or insulin, this medication can be added. If blood sugar control remains inadequate with complex combination therapy, adding this medication may improve blood sugar control. Therefore, this medication effectively improves blood sugar control in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

This medication is administered as a single dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (glomerular filtration rate 60 or more but less than 90): No dosage adjustment required. - Moderate renal impairment (glomerular filtration rate 45 or more but less than 60): No dosage adjustment required. - Moderate renal impairment

Precautions

This medication may rarely cause serious allergic reactions after administration, so if symptoms such as skin rash or difficulty breathing occur, it should be discontinued immediately and a physician consulted. During the use of this medication, serious inflammation of the pancreas, known as pancreatitis, may arise. If symptoms such as abdominal pain, vomiting, or nausea appear, healthcare personnel should be informed immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should be avoided in patients with allergies to this medication or its components. Patients with impaired kidney function should adjust the dosage of this medication; thus, kidney function tests should be performed before administration, and instructions from a physician should be followed. This medication may cause hypoglycemia when used alone or in combination with other diabetes treatments, so patients should be vigilant for symptoms of hypoglycemia and check blood sugar levels frequently if necessary. Severe joint pain or skin blisters may occur; if these symptoms arise, the medication should be stopped immediately and a physician consulted. Pregnant or breastfeeding women are advised not to use this medication, and safety in children and adolescents under 18 has not been established. Elderly patients should be monitored regularly for kidney function as it may decline when taking this medication. In case of overdose, general emergency treatment should be administered and hemodialysis considered if necessary; therefore, the prescribed dosage must be strictly followed. This medication has few significant drug interactions, but it is advisable to consult a physician or pharmacist when taking it with specific medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, severe allergic reactions, skin rash, Stevens-Johnson syndrome and exfoliative skin disease, severe skin adverse reactions, acute pancreatitis, liver abnormalities (though jaundice-related symptoms are not specified, the potential for increased liver enzymes, acute pancreatitis, and liver cancer are included), acute kidney failure, respiratory problems related to difficulty breathing are not explicitly stated but can include impaired kidney function, severe

Mild side effects

  • Upper respiratory infections
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • hypertension
  • 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 protect it from air exposure, and it is best to keep it at a cool room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Pink, round, biconvex 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.