Medication info

Sitagliptin 100 mg Tablets (Sitagliptin Phosphate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate›124.08mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
Beige, biconvex, round film-coated tablets
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Active

MFDS item code 201603056 · Approved 2016.05.30

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered as a single dose of 100 mg once daily, whether in monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken irrespective of meals. Dosage adjustments for patients with renal impairment: 1. Mild renal impairment (eGFR 60-90): No dosage adjustment necessary 2. Moderate renal impairment (eGFR 45-60): No dosage adjustment necessary 3. Moderate renal impairment (eGFR 30-45): Administer 50 mg once daily

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Type 2 diabetes
  • abnormal blood glucose control
View approved original text

This medication is used to help control blood glucose levels in patients with type 2 diabetes in conjunction with dietary and exercise regimens. It can be administered together with metformin when initial use of diabetes medications or monotherapy has not led to adequate blood glucose control. Furthermore, when sufficient blood glucose control is not achieved with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this medication can be used in combination. If blood glucose control remains inadequate despite using various medications, this medication can be added to enhance therapeutic effect. Therefore, it is used to more effectively improve blood glucose control.

How to take

Adult dose

This medication is administered as a single dose of 100 mg once daily, whether in monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken irrespective of meals. Dosage adjustments for patients with renal impairment: 1. Mild renal impairment (eGFR 60-90): No dosage adjustment necessary 2. Moderate renal impairment (eGFR 45-60): No dosage adjustment necessary 3. Moderate renal impairment (eGFR 30-45): Administer 50 mg once daily

Precautions

This medication is used for the treatment of diabetes, and some patients may experience severe allergic reactions after administration. Such reactions may include anaphylaxis, angioedema, and skin conditions such as Stevens-Johnson syndrome, which causes severe damage to the skin. These symptoms may appear within the first 3 months after starting the medication, so careful monitoring is required. If an allergic reaction is suspected, discontinue the medication immediately and consult a physician. Additionally, this medication may cause a serious side effect called pancreatitis, which is inflammation of the pancreas; therefore, if symptoms of pancreatitis such as abdominal pain, nausea, or vomiting occur, notify healthcare personnel immediately. If pancreatitis is suspected, other medications taken in conjunction with this drug may also need to be discontinued. Patients with type 1 diabetes, diabetic ketoacidosis, or who have hypersensitivity to this medication or its components should not take this medication. Patients with impaired kidney function may find elimination of this drug challenging, so cautious dosage adjustment is necessary, and regular assessments of kidney function before and after administration are essential. In clinical trials, patients taking this medication commonly experienced side effects like upper respiratory tract infections, headaches, and nasopharyngitis. In particular, when taken in conjunction with insulin or sulfonylureas, the risk of hypoglycemia may increase, necessitating periodic blood glucose checks and possible adjustments of other medication dosages. Rare side effects such as severe joint pain or blistering akin to bullous pemphigoid have also been reported, so inform a physician immediately should such symptoms arise. The use of this medication is not recommended for pregnant or breastfeeding women, and safety and effectiveness in children and adolescents under 18 years have not been established. In case of overdose, the patient's condition should be closely monitored with general treatment and electrocardiograms, as this medication can be partially removed by hemodialysis. This medication has minimal interactions with other diabetes treatments or medications, but caution is advised when combining with specific drugs, so consultation with healthcare professionals is recommended. Elderly patients may have diminished kidney function, making dosage adjustments and kidney function testing even more critical. If any suspected abnormal symptoms occur during treatment with this medication, promptly consult healthcare personnel for appropriate actions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, severe allergic reactions, Stevens-Johnson syndrome and exfoliative skin diseases, severe rash with high fever, blistering, skin peeling, pain in the mucous membranes of the mouth/eyes, acute pancreatitis (including hemorrhagic or necrotizing), severe and debilitating joint pain, bullous pemphigoid, liver abnormalities (elevated liver enzymes, jaundice-like symptoms), acute renal failure, difficulty breathing and respiratory issues,

Mild side effects

  • Upper respiratory tract infections
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • indigestion
  • dizziness
  • increased triglycerides in the blood
  • 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 exposure to air. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius to preserve the drug's effectiveness for a longer duration.

Appearance and packaging

Appearance

Beige, biconvex, round film-coated tablets

Package unit

30 tablets (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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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.