Medication info
Sitagliptin Tablets 50 mg (Sitagliptin Phosphate)

Sitagliptin Tablets 50 mg (Sitagliptin Phosphate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate›62.04mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
A round film-coated tablet with a bright beige color and a biconvex shape.
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 201503228 · Approved 2015.05.27 · Insurance code 663607520

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered at a dosage of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. This drug can be taken without regard to meals. Dosage Adjustment in Patients with Renal Impairment: 1. In patients with mild renal impairment (eGFR ≥ 60 mL/min/1.73 m² and < 90 mL/min/1.73 m²), no dosage adjustment is needed. 2. In patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m² and < 60 mL/min/1.73 m²), no dosage adjustment is needed.

Ingredients

Manufacturer
한국프라임제약(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 serves to assist dietary and exercise therapy in improving blood sugar control in patients with type 2 diabetes. It can be administered as a monotherapy initially, and in patients with uncontrolled blood glucose who have not previously received diabetes treatment, it is used in combination with metformin. Additionally, when blood sugar control is insufficient with sulfonylurea, metformin, thiazolidinedione, or insulin monotherapy, it is treated in combination with this medication. A treatment regimen which adds this medication is also used when control remains difficult with combinations of sulfonylurea and metformin, thiazolidinedione and metformin, or insulin and metformin. This medication effectively improves blood sugar control across various treatment combinations.

How to take

Adult dose

This medication is administered at a dosage of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. This drug can be taken without regard to meals. Dosage Adjustment in Patients with Renal Impairment: 1. In patients with mild renal impairment (eGFR ≥ 60 mL/min/1.73 m² and < 90 mL/min/1.73 m²), no dosage adjustment is needed. 2. In patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m² and < 60 mL/min/1.73 m²), no dosage adjustment is needed.

Precautions

This medication may cause allergic reactions; if rash, difficulty breathing, swelling, or other symptoms appear, usage should be stopped immediately and a doctor should be consulted. While taking this medication, inflammation of the pancreas, known as pancreatitis, may occur. If symptoms such as abdominal pain, vomiting, or nausea arise, inform healthcare professionals immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should be avoided in patients with allergies to this medication or its components. Patients with impaired kidney function may need to adjust the dosage of this medication, therefore, it should be taken according to a doctor's instructions. While taking this medication there may be side effects such as upper respiratory infections, nasopharyngitis, headache, diarrhea, nausea, and others; if symptoms worsen, consult a doctor. There is an increased risk of hypoglycemia when this medication is used in combination with other antidiabetic drugs, particularly insulin or sulfonylureas, so it is necessary to monitor blood sugar levels regularly and adjust the dosage as needed. This medication may cause severe joint pain or blistering skin conditions, so if there is severe joint pain or blisters or rashes appear on the skin, inform a doctor immediately. It is advisable for pregnant or breastfeeding women not to use this medication, and safety has not been established for children or adolescents under 18 years of age. Elderly patients may experience decreased kidney function, so renal function tests should be performed before use, and dosage adjusted according to a doctor's guidance. In case of overdose, general treatments such as gastrointestinal decontamination and ECG monitoring may be required, and some drug may be removed through hemodialysis. This medication has relatively few interactions with other drugs, but when used with digoxin, blood concentration should be monitored. If unusual symptoms develop during use, it is important to consult healthcare professionals immediately for appropriate measures.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, severe allergic reactions, exfoliative skin diseases (including Stevens-Johnson syndrome), severe rash accompanied by fever, blistering, skin peeling, oral/ocular mucous membrane pain, acute pancreatitis (including hemorrhagic or necrotizing), difficulty breathing, asthma attacks, respiratory distress, liver abnormalities (including jaundice), elevated liver enzyme levels, severe headache, confusion, seizures, visual disturbances, paralysis, severe reactions

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • muscle pain
  • limb pain
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  • back pain
  • itching
  • 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 medication should be stored in a tightly sealed container to prevent air from entering and is best kept at a temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

A round film-coated tablet with a bright beige color and a biconvex shape.

Package unit

30 tablets/box [10 tablets/PTP X 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.

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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.