Medication info

Sitagliptin Tablets 25 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Pink, round, biconvex film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Expired

MFDS item code 202100077 · Approved 2021.01.05

This product's status changed to Expired on 2026.01.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
In monotherapy or combination therapy, the recommended dose is 100 mg once daily, with a maximum daily dose of 100 mg. This medication can be taken regardless of meals. For patients with renal impairment, dosage adjustment may be necessary, depending on renal function. - For mild renal impairment (eGFR ≥ 60 and < 90), no dosage adjustment is needed. - For moderate renal impairment (eGFR ≥ 45 and < 60), dosage adjustment is needed.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

  • Difficulty in blood sugar control for patients with type 2 diabetes
View approved original text

This medication is used together with diet and exercise to improve blood sugar control in patients with type 2 diabetes. It can be given alone to patients who have not previously received diabetes medication. However, if blood sugar control is difficult with monotherapy, it can be used in combination with Metformin. When sufficient blood sugar control is not achieved with sulfonylureas, Metformin, thiazolidinediones, or insulin, this drug can be added to enhance therapeutic effect. It is used to improve blood sugar control in combination with various medications.

How to take

Adult dose

In monotherapy or combination therapy, the recommended dose is 100 mg once daily, with a maximum daily dose of 100 mg. This medication can be taken regardless of meals. For patients with renal impairment, dosage adjustment may be necessary, depending on renal function. - For mild renal impairment (eGFR ≥ 60 and < 90), no dosage adjustment is needed. - For moderate renal impairment (eGFR ≥ 45 and < 60), dosage adjustment is needed.

Precautions

This medication may cause severe allergic reactions in some patients; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after administration, use should be discontinued immediately and a physician should be consulted. If symptoms of pancreatitis such as severe abdominal pain, vomiting, or fever occur during treatment, medical personnel should be notified immediately, and drug therapy should be stopped if pancreatitis is suspected. This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients who have had an allergic reaction to this drug or its components. For patients with decreased renal function, drug concentration may increase, so dosage should be adjusted according to renal function test results and used with caution. Hypoglycemic symptoms may occur during treatment, especially when used in combination with insulin or sulfonylureas, thus blood sugar should be frequently monitored and immediate action taken if symptoms appear. Rarely, severe joint pain or skin blistering symptoms have been reported; if these symptoms arise, the physician should be informed immediately, and discontinuation of the medication and specialist consultation may be necessary. Women who are pregnant or breastfeeding are advised against using this medication due to unestablished safety, and safety and efficacy have not been confirmed for children under 18. For elderly patients, dosage adjustment and regular renal function testing are needed due to potential decreases in renal function. In case of overdose, general first aid measures should be performed, and some drugs may be eliminated by hemodialysis if necessary. This medication does not have significant interactions with some other drugs; however, monitoring is needed for patients taking digoxin. Lastly, it is important to consult medical personnel immediately if any unusual symptoms or discomfort occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, exfoliative skin disease (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, severe joint pain with disability, bullous pemphigoid, pneumonia, diabetic complications, metabolic acidosis, falls, cardiac arrest

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • constipation
  • vomiting
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • nausea
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • gastritis
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction
  • hypoglycemia

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

Storage

This medication should be stored in a tightly closed container to keep out air and should be kept at a temperature between 1 to 30 degrees Celsius at room temperature. This helps maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablets

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.

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.