Medication info
Sitagliptin 50 mg Tablet (Sitagliptin Hydrochloride Hydrate)

Sitagliptin 50 mg Tablet (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
A light apricot-colored, biconvex round film-coated tablet
Packaging
28 tablets/box [14 tablets/PTPX2]
Approval status
Active

MFDS item code 202101404 · Approved 2021.02.18 · Insurance code 657807910

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This drug is administered at a dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. For patients with renal impairment, a dose of 50 mg is administered once daily for moderate renal impairment (glomerular filtration rate 30–45 mL/min/1.73 m2). In cases of severe renal impairment (glomerular filtration rate 15–30 mL/min/1.73 m2) or end-stage renal disease requiring hemodialysis or peritoneal dialysis (glomerular filtration rate <

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control for patients with type 2 diabetes
View approved original text

This medicine is used with diet and exercise to help patients with type 2 diabetes control their blood sugar. It can be administered alone for patients beginning treatment, and when monotherapy does not sufficiently control blood sugar, it is used in combination with metformin. Additionally, it can be added to treatment when sufficient control is difficult with sulfonylurea, thiazolidinedione, or insulin monotherapy. This drug enhances therapeutic effects even when blood sugar control is inadequate despite combination therapy with multiple medications. It is flexibly used in various cases to improve blood sugar control.

Dosage and Administration

Adult dosage

This drug is administered at a dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. For patients with renal impairment, a dose of 50 mg is administered once daily for moderate renal impairment (glomerular filtration rate 30–45 mL/min/1.73 m2). In cases of severe renal impairment (glomerular filtration rate 15–30 mL/min/1.73 m2) or end-stage renal disease requiring hemodialysis or peritoneal dialysis (glomerular filtration rate <

Precautions

This medicine may cause severe hypersensitivity reactions after administration, so if allergic symptoms occur, discontinue use immediately. Consult a physician immediately if symptoms of pancreatitis appear while taking the medication, and discontinue use if necessary. Patients with type 1 diabetes or hypersensitivity to any component of this drug should not take it. Patients with decreased kidney function need to adjust the dosage, so consult a physician. When used in combination with other hypoglycemic agents, caution is needed due to the risk of hypoglycemia, and dosage adjustments of other medications may be necessary. Prolonged use may lead to adverse reactions such as arthralgia, skin rash, and blistering skin diseases, so inform a physician if symptoms occur. Pregnant or breastfeeding women are advised to avoid taking this medication. Elderly patients should undergo regular kidney function tests as kidney function may decline. In case of overdose, immediate medical attention is required, and some removal may be possible through hemodialysis. This drug has little effect on cardiovascular safety, but it is important to consult healthcare professionals if adverse reactions occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis (severe allergic reaction), rashes, skin peeling, mucosal pain in the mouth/eyes (such as Stevens-Johnson syndrome and other severe skin reactions), acute pancreatitis, acute renal failure, severe and disabling arthralgia, blistering dermatitis, shortness of breath or difficulty breathing, liver abnormalities (increased liver enzyme levels, possibility of jaundice), severe edema

Mild side effects

  • Headache
  • upper respiratory tract infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • gastritis
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This medicine should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept at room temperature between 1 and 30 degrees Celsius. This helps maintain the efficacy of the drug and prevents degradation.

Appearance and packaging

Appearance

A light apricot-colored, biconvex round 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.