Medication info

Sitagliptin Tablets 100 mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
Beige colored, round, biconvex film-coated tablet
Packaging
Company packaging unit
Approval status
Expired

MFDS item code 201502209 · Approved 2015.04.14

This product's status changed to Expired on 2025.04.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 dosage of 100 mg for both monotherapy and combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments may be necessary. - Mild renal impairment (eGFR 60-90 mL/min/1.73 m2): No dosage adjustment required. - Moderate renal impairment (eGFR 45-60 mL/min/1.73 m2): Dosage adjustment needed.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar in patients with type 2 diabetes. It can be administered alone and may be combined with metformin in cases where blood sugar control is difficult with monotherapy, especially in patients without prior experience of diabetes treatment. Furthermore, it can be added to therapy when adequate blood sugar control is not achieved with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin. Additionally, it can improve effectiveness even when various medications are combined but blood sugar control remains inadequate. This drug aids in the improvement of blood sugar control through these diverse methods of administration.

How to take

Adult dose

This medication is administered once daily at a dosage of 100 mg for both monotherapy and combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments may be necessary. - Mild renal impairment (eGFR 60-90 mL/min/1.73 m2): No dosage adjustment required. - Moderate renal impairment (eGFR 45-60 mL/min/1.73 m2): Dosage adjustment needed.

Precautions

This medication is used for the treatment of diabetes, and serious allergic reactions may occur in some patients. Such reactions can manifest within the first three months after taking the medication, with symptoms such as rash or swelling appearing on the skin, so caution is advised. Additionally, pancreatitis may develop during treatment, demonstrated by abdominal pain, vomiting, and nausea; patients should consult a physician immediately if these symptoms occur. This drug should not be used in patients with type 1 diabetes or those with specific allergies, and dosage adjustments may be required for patients with impaired renal function. Common side effects reported in clinical trials include upper respiratory infections, headache, nasopharyngitis, diarrhea, nausea, etc., and hypoglycemic symptoms may occur, making tight blood sugar control critical. Caution is especially necessary when used with insulin or sulfonylureas as the risk of hypoglycemia may increase. This drug is not recommended for pregnant women, and breastfeeding women should also avoid its use. Safety in children and adolescents under 18 years of age has not been established. In case of overdose, general emergency care should be given, and if necessary, the drug may be removed through hemodialysis. If symptoms such as joint pain or skin blistering occur during the use of this drug, it is imperative to consult a healthcare professional immediately, and the medication should be discontinued if such symptoms arise. Lastly, this drug has the potential for interactions with other medications; therefore, it is essential to inform the physician or pharmacist about any other medications being taken, particularly when taking it alongside cyclosporine or digoxin.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, Stevens-Johnson syndrome and exfoliative skin diseases, acute pancreatitis, acute renal failure, severe joint pain, bullous pemphigoid, rhabdomyolysis, cardiac arrest

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • dyspepsia
  • dizziness
  • increased triglycerides
  • hypertension
  • hypernatremia
  • erectile dysfunction
  • weight loss

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also recommended to store it at room temperature between 1°C to 30°C.

Appearance and packaging

Appearance

Beige colored, round, biconvex film-coated tablet

Package unit

Company packaging unit

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.

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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.