Medication info

SITD-M tablet 25 milligrams (Sitagliptin hydrochloride monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pink, round, biconvex film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP X 2]
Approval status
Active

MFDS item code 202101983 · Approved 2021.03.03

Summary

Main use
Improvement of blood sugar 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 regardless of meals. In patients with kidney impairment, dosage adjustments are required based on renal function. In patients with mild to moderate renal impairment (eGFR 45–90 mL/min/1.73 m2), dosage adjustments are not necessary.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of 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 to improve blood sugar control in patients with type 2 diabetes. It is administered as an adjunct to dietary and exercise therapy and may be used alone in patients who have difficulty achieving initial blood sugar control. If the patient has not previously used diabetes medications or if blood sugar control is insufficient with monotherapy, it can be taken in combination with metformin. Additionally, this medication can be used in combination with sulfonylureas, metformin, thiazolidinediones, or insulin in patients who are not achieving adequate blood sugar control with these medications alone to enhance therapeutic efficacy. In cases of difficulty achieving blood sugar control even with combination therapy, this medication can be added to assist in blood sugar control. Therefore, this medication effectively improves blood sugar control in type 2 diabetes.

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 regardless of meals. In patients with kidney impairment, dosage adjustments are required based on renal function. In patients with mild to moderate renal impairment (eGFR 45–90 mL/min/1.73 m2), dosage adjustments are not necessary.

Precautions

This medication may cause severe allergic reactions in some patients. Such reactions can occur within the first 3 months after starting the medication, so careful monitoring is necessary. Moreover, during treatment with this medication, pancreatitis (inflammation of the pancreas) may occur, so if symptoms such as abdominal pain or vomiting appear, consultation with a physician is required immediately. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication, nor should patients with a history of allergic reactions to this medication or its components. Patients with impaired renal function should adjust the dosage of this medication, following their physician's instructions. During the treatment with this medication, side effects such as cold symptoms, headache, indigestion, diarrhea, and dizziness may occur, and patients may also experience hypoglycemia, making thorough blood sugar management essential. Particularly, caution is needed as the risk of hypoglycemia may increase when used in combination with insulin or sulfonylureas. This medication has been reported to seldom cause serious side effects such as arthralgia or blistering conditions resembling bullous pemphigoid, and patients should report any such symptoms to their physician immediately. It is recommended that women who are pregnant or breastfeeding avoid using this medication, and safety and efficacy have not been established for children or adolescents under 18 years of age. Elderly patients should be monitored for reduced renal function, necessitating dosage adjustments and regular renal function checks. In case of overdose, general treatment should be administered, and blood dialysis may be considered if necessary. Finally, this medication does not significantly interact when taken with several other medications, but interactions may occur with some drugs, so it is crucial to consult a physician or pharmacist regarding any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • rash
  • Stevens-Johnson syndrome
  • cutaneous vasculitis
  • acute pancreatitis
  • acute renal failure
  • cardiac arrest
  • severe and disabling arthralgia
Show 7 more
  • bullous pemphigoid
  • rhabdomyolysis
  • pneumonia
  • diabetic complications
  • metabolic acidosis
  • severe hypoglycemia
  • severe allergic reactions

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • abdominal pain
  • myalgia
  • limb pain
  • back pain
Show 12 more
  • pruritus
  • thrombocytopenia
  • indigestion
  • dizziness
  • ALT increase
  • AST increase
  • increased 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 ingress, and the storage temperature must be maintained between 1 and 30 degrees Celsius at room temperature. Storing it in this manner will help maintain its efficacy for longer.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablets

Package unit

28 tablets/box [14 tablets/PTP X 2]

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.