Medication info

Sitagliptin Alpha Tablet 25mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Pink, round, biconvex film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP×2], 30 tablets/box [10 tablets/PTP×3]
Approval status
Approval withdrawn

MFDS item code 202004069 · Approved 2020.05.29

This product's status changed to Approval withdrawn on 2024.09.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dosage of 100 mg, whether used alone or in combination, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In cases of renal impairment, dosage adjustments should be made according to kidney function. - Mild renal impairment patients (eGFR ≥ 60 and < 90): No dosage adjustment needed. - Moderate renal impairment patients (eGFR ≥ 45 and < 60): No dosage adjustment needed. - Moderate renal impairment

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement in blood glucose control in type 2 diabetes

  • Difficulties in blood glucose control in patients with type 2 diabetes
View approved original text

This medication is used to assist patients with type 2 diabetes who find it difficult to control blood glucose levels with diet and exercise alone. Initially, it can be administered as monotherapy, and if blood glucose is not well controlled with other antidiabetic medications, it may be used in combination with metformin, sulfonylureas, thiazolidinediones, insulin, and others. When multiple therapeutic approaches do not sufficiently control blood glucose, this medication can be added to improve blood sugar levels. Thus, it is used effectively at various treatment stages to control blood glucose.

How to take

Adult dose

This medication is administered once daily at a dosage of 100 mg, whether used alone or in combination, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In cases of renal impairment, dosage adjustments should be made according to kidney function. - Mild renal impairment patients (eGFR ≥ 60 and < 90): No dosage adjustment needed. - Moderate renal impairment patients (eGFR ≥ 45 and < 60): No dosage adjustment needed. - Moderate renal impairment

Precautions

This medication can cause severe allergic reactions, so if symptoms such as rash or difficulty breathing occur, use should be stopped immediately, and a doctor should be consulted. Additionally, serious side effects such as pancreatitis, which is inflammation of the pancreas, have been reported. If symptoms such as abdominal pain or vomiting occur, it is important to inform medical personnel immediately. This medication should not be used in patients with type 1 diabetes or severe renal impairment. Patients with reduced kidney function need to adjust the dosage of this medication, so it should be taken according to a doctor's instructions. During treatment with this medication, side effects such as infections, headaches, dyspepsia, and diarrhea may occur. If symptoms persist or worsen, consult a physician. Using other blood glucose-lowering agents, especially in combination with insulin or sulfonylureas, may increase the risk of hypoglycemia, so blood glucose levels should be closely monitored. Severe joint pain or blistering skin diseases may occur, so if such symptoms arise, inform the doctor immediately. Pregnant or breastfeeding women are advised to avoid using this medication, and safety and efficacy have not been established in children under 18 years of age. Elderly patients may have reduced kidney function, so it is recommended to have kidney function tests before and after taking this medication. In cases of overdose, general emergency measures should be taken, and if necessary, dialysis can help remove some of this medication. This medication has relatively few drug interactions, but the concentration may change when used in combination with certain medications, so be sure to inform your doctor or pharmacist about any medicines being taken.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions (hives, angioedema, anaphylaxis), Stevens-Johnson syndrome and exfoliative skin disease, acute pancreatitis, acute renal failure, severe and disabling joint pain, bullous pemphigoid, severe hypoglycemia, pneumonia, diabetes complications, metabolic acidosis, falls, cardiac arrest

Mild side effects

  • Headache
  • upper respiratory tract infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • myalgia
  • limb pain
Show 12 more
  • back pain
  • pruritus
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • 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 that protects it from air and kept at room temperature between 1 and 30 degrees Celsius. Proper storage can maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP×2], 30 tablets/box [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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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.