Medication info
Sitagliptin Tablets 100 mg (Sitagliptin Hydrochloride Monohydrate)

Sitagliptin Tablets 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.37mg / 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 202102017 · Approved 2021.03.04 · Insurance code 645605600

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is to be administered once daily at a dose of 100 mg, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Dosage adjustment for patients with renal impairment: Mild to moderate renal impairment (eGFR 45 to less than 90) does not require dosage adjustment. Patients with moderate renal impairment (eGFR 30 to less than 45) are administered 50 mg once daily.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
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This medicine is used to help control blood glucose in patients with type 2 diabetes alongside diet and exercise therapy. Initially, it can be administered alone, and if sufficient blood glucose control is not possible with monotherapy, it is used in combination with metformin. Additionally, if blood glucose control is difficult with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin, this medication can be used in combination. It also improves blood glucose control when combination therapy with various medications is ineffective. Thus, it helps in efficiently controlling glucose levels in diverse situations.

Dosage and Administration

Adult dosage

This medication is to be administered once daily at a dose of 100 mg, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Dosage adjustment for patients with renal impairment: Mild to moderate renal impairment (eGFR 45 to less than 90) does not require dosage adjustment. Patients with moderate renal impairment (eGFR 30 to less than 45) are administered 50 mg once daily.

Precautions

This medication may cause severe allergic reactions after administration; therefore, if symptoms such as skin rash or difficulty in breathing occur, it should be discontinued immediately, and a doctor should be consulted. There is a risk of developing serious pancreatic diseases such as pancreatitis while taking this medication; hence, if symptoms like abdominal pain, vomiting, or loss of appetite appear, immediate notification to healthcare personnel is necessary. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and those who are allergic to this drug or its components should avoid it. Patients with impaired renal function need dosage adjustments; thus, renal function tests should be performed, and usage should follow a doctor's guidance. Hypoglycemia may occur when taking this drug alone or in combination with other antidiabetic medications; therefore, it is essential to be aware of hypoglycemic symptoms and check blood sugar levels frequently if necessary. During treatment with this medication, side effects such as headache, upper respiratory infections, rhinitis, diarrhea, nausea, indigestion, dizziness, increased blood triglycerides, elevated low-density lipoprotein, hyperglycemia, weight loss, hypertension, hypernatremia, and erectile dysfunction may occur, so if symptoms are severe or persistent, consultation with medical professionals is advised. If symptoms like severe joint pain or blisters on the skin appear, the use of this medication should be stopped immediately and specialist care should be sought. Pregnant or breastfeeding women are advised to avoid this medication, and its safety has not been established in children or adolescents under 18 years of age. Elderly patients are at risk of reduced renal function, so regular kidney function tests before and after taking this medication are necessary. In case of overdose, it is essential to visit a hospital immediately for appropriate treatment, and this drug can be partially removed by hemodialysis. There may be interactions with other medications, so inform healthcare professionals of any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome, severe skin reactions, exfoliative dermatitis, acute pancreatitis, shortness of breath or difficulty breathing, asthma attacks, liver dysfunction (jaundice), severe headache, seizures, altered consciousness, visual disturbances, paralysis, decreased urine output, severe edema, increased blood pressure, severe hypoglycemia, acute renal failure, severe and disabling

Mild side effects

  • Upper respiratory infection
  • rhinitis
  • constipation
  • vomiting
  • headache
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • diarrhea
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  • nausea
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • elevated low-density lipoprotein
  • hyperglycemia
  • 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 air exposure and should be kept at room temperature between 1 and 30 degrees Celsius for safety. This ensures that the effectiveness of the medication is maintained and prevents degradation.

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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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.