Medication info
Sitagliptin Hydrochloride Hydrate 100 mg (Sitagliptin)

Sitagliptin Hydrochloride Hydrate 100 mg (Sitagliptin)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Light orange round biconvex film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP×3)]
Approval status
Active

MFDS item code 202100087 · Approved 2021.01.06 · Insurance code 665508330

Summary

Main use
Improvement in blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dose of 100 mg for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken independently of meals. For patients with renal impairment, dosage adjustments are needed based on kidney function, with no dosage adjustments necessary for mild and moderate kidney impairment (glomerular filtration rate [eGFR] 45 to less than 90). If the glomerular filtration rate [eGFR] is between 30 and less than 45, the dose is 50 mg once daily.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Improvement in blood glucose control in type 2 diabetes

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

This drug is used in conjunction with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone for patients needing initial treatment, and if blood glucose control is insufficient with monotherapy, it can be combined with other diabetes medications such as metformin. Additionally, if blood glucose control is difficult even with monotherapy with sulfonylurea, thiazolidinediones, or insulin or other combination therapies, this medication can be added to enhance blood sugar control. It is used to effectively improve patients' blood sugar levels.

How to take

Adult dose

This medication is administered once daily at a dose of 100 mg for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken independently of meals. For patients with renal impairment, dosage adjustments are needed based on kidney function, with no dosage adjustments necessary for mild and moderate kidney impairment (glomerular filtration rate [eGFR] 45 to less than 90). If the glomerular filtration rate [eGFR] is between 30 and less than 45, the dose is 50 mg once daily.

Precautions

This medication may cause severe allergic reactions after administration; therefore, if symptoms such as skin rash or difficulty breathing occur, use should be discontinued immediately and medical attention sought. During the course of treatment, severe pancreatitis may occur, so if symptoms such as abdominal pain or vomiting appear, consult a doctor immediately. This medication should not be used by patients with type 1 diabetes or diabetic ketoacidosis, nor should anyone with an allergy to this drug or its components take it. Patients with impaired kidney function should have their dosage adjusted; therefore, treatment should be conducted under a doctor's direction, and regular kidney function tests are important. This medication may cause hypoglycemia; thus, when taken with insulin or sulfonylurea, carefully monitor for hypoglycemic symptoms and adjust the dosage of other medications as necessary. Additionally, severe joint pain or skin blisters may appear during the treatment, and if such symptoms arise, they should be reported to medical personnel immediately. Pregnant or breastfeeding women are advised to avoid using this medication, and safety has not been established for children and adolescents under 18. Elderly patients may have reduced kidney function, so kidney function should be assessed before taking this medication, and periodic checks during treatment are necessary. In the case of overdose, standard treatment should be initiated, and if necessary, some of the medication may be removed via dialysis. Drug interactions are generally low; however, when taking certain medications, consultation with a doctor is recommended, especially when taking digoxin, as blood concentrations should be carefully monitored.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, exfoliative dermatitis, acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure, elevated liver enzymes, hepatic abnormalities (jaundice), severe reactions accompanied by disabilities

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • dyspepsia
  • nausea
  • diarrhea
  • constipation
  • myalgia
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • abdominal pain
  • dizziness
  • increased triglycerides in the blood
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in a tightly sealed container to prevent air exposure, at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's efficacy for a longer time.

Appearance and packaging

Appearance

Light orange round biconvex film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP×3)]

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.