Medication info
Sitagliptin 50 mg Tablets (Sitagliptin Hydrochloride Monohydrate)

Sitagliptin 50 mg Tablets (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Light apricot-colored, biconvex, round film-coated tablets
Packaging
28 tablets/PTP [(14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 202101174 · Approved 2021.02.08 · Insurance code 622804830

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
For monotherapy or combination therapy, administer 100 mg once daily with a maximum daily dose of 100 mg. It can be taken without regard to meals. Dosage adjustments for patients with renal impairment: - Mild renal impairment: No dosage adjustment required - Moderate renal impairment (eGFR 45-60): No dosage adjustment required - Moderate renal impairment (eGFR 30-45): 50 mg once daily - Severe renal impairment and end-stage renal disease (eGFR 1

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in managing blood sugar levels in patients with type 2 diabetes
View approved original text

This medication is used along with dietary and exercise therapies to improve blood sugar control in patients with type 2 diabetes. It can be administered alone and can be used in combination with metformin in cases where blood sugar control is difficult with monotherapy in patients who have never received diabetes medication before. Additionally, this medication is used together when sufficient blood sugar control is not achieved with mono therapies of sulfonylurea, metformin, thiazolidinedione, or insulin. In cases where blood sugar control remains difficult after treatment with multiple medications, this drug is added to enhance therapeutic efficacy. In this way, this medication is used effectively to improve blood sugar control in various treatment scenarios.

How to take

Adult dose

For monotherapy or combination therapy, administer 100 mg once daily with a maximum daily dose of 100 mg. It can be taken without regard to meals. Dosage adjustments for patients with renal impairment: - Mild renal impairment: No dosage adjustment required - Moderate renal impairment (eGFR 45-60): No dosage adjustment required - Moderate renal impairment (eGFR 30-45): 50 mg once daily - Severe renal impairment and end-stage renal disease (eGFR 1

Precautions

This medication may cause severe allergic reactions; therefore, if symptoms such as skin rash or difficulty breathing occur after taking the drug, discontinue use immediately and consult a doctor. Also, during treatment with this medication, there is a risk of developing pancreatitis, which can lead to inflammation of the pancreas. If symptoms like upper abdominal pain, vomiting, or nausea occur, seek medical attention immediately. This medication is not to be used in patients with type 1 diabetes or diabetic ketoacidosis, and should be avoided in patients with allergies to the drug or its components. Patients with impaired kidney function must have their dosage adjusted, so regular kidney function tests and adherence to a physician's instructions are required. Patients should be mindful of hypoglycemia symptoms during treatment. The risk of hypoglycemia may increase when used with other hypoglycemic agents like insulin or sulfonylureas, so blood sugar levels should be monitored frequently. Side effects such as headaches, upper respiratory infections, nasopharyngitis, diarrhea, and nausea may occur; if symptoms are severe, consult a physician. It is safer for pregnant or breastfeeding women to avoid this medication, and its safety and efficacy have not been established in children or adolescents under the age of 18. Elderly patients may have impaired kidney function and should consult a doctor before taking this medication, maintaining regular kidney function evaluations. In the case of overdose, seek immediate medical attention for appropriate treatment, as this drug can be partially removed through hemodialysis. If symptoms like joint pain or blistering skin appear during treatment, inform a doctor immediately and stop taking the medication. Finally, this medication may interact with other drugs, so it's essential to inform your physician or pharmacist about any current medications being taken.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • anaphylaxis
  • angioedema
  • rash
  • exfoliative skin diseases
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • severe hypoglycemia
  • bullous pemphigoid
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  • severe and debilitating arthralgia
  • acute renal failure
  • pneumonia
  • diabetic complications
  • metabolic acidosis
  • 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
  • nausea
  • dyspepsia
  • dizziness
  • increased triglycerides
  • gastritis
  • 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 avoid exposure to air and is recommended to be kept at room temperature between 1 to 30 degrees Celsius. This helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Light apricot-colored, biconvex, round film-coated tablets

Package unit

28 tablets/PTP [(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.