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
알리코제약(주)
Appearance
Light apricot-colored, round, biconvex film-coated tablets
Packaging
PTP - 28 tablets/box [(14 tablets/PTP×2)]
Approval status
Active

MFDS item code 202101320 · Approved 2021.02.16 · Insurance code 656005350

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This drug is administered once daily at 100 mg, used as monotherapy or in combination, with a maximum dosage of 100 mg per day. In patients with moderate renal impairment with an eGFR of 30-45 mL/min/1.73 m², 50 mg is administered once daily. In patients with severe renal impairment or end-stage renal disease (ESRD), 25 mg is administered once daily. It can be taken regardless of meals.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This medicine helps patients with type 2 diabetes effectively control their blood sugar in conjunction with diet and exercise therapy. It can be administered alone, and can be used by patients who have not received diabetes drug therapy before. If blood sugar control is insufficient with monotherapy, it is administered in combination with metformin. Additionally, if any one of sulfonylureas, metformin, thiazolidinediones, or insulin is ineffective on its own, this drug can be used in combination. Furthermore, even in cases where it is difficult to control blood sugar despite multiple medications, this drug may be added to the treatment regimen. Ultimately, this drug is used to improve blood sugar control in patients and assist in diabetes management.

How to take

Adult dose

This drug is administered once daily at 100 mg, used as monotherapy or in combination, with a maximum dosage of 100 mg per day. In patients with moderate renal impairment with an eGFR of 30-45 mL/min/1.73 m², 50 mg is administered once daily. In patients with severe renal impairment or end-stage renal disease (ESRD), 25 mg is administered once daily. It can be taken regardless of meals.

Precautions

This drug may rarely cause severe allergic reactions after administration; if symptoms such as skin rash or breathing difficulties occur, use should be stopped immediately and a doctor consulted. This drug may induce a condition known as acute pancreatitis, which involves inflammation of the pancreas, so if abdominal pain, vomiting, or severe abdominal discomfort occurs, it is important to visit a hospital promptly. It is considered safe not to use this drug in patients with type 1 diabetes or diabetic ketoacidosis. Patients with diminished kidney function may face an increased risk of side effects due to difficulty in excretion of this drug, so dosage adjustments or careful use is necessary. While using this drug, hypoglycemic symptoms may occur, so particularly when taken with other hypoglycemic agents such as insulin or sulfonylureas, blood glucose levels should be monitored closely. If symptoms such as joint pain or blisters on the skin appear during treatment with this drug, promptly inform a doctor and discontinue use if necessary. Women who are pregnant or breastfeeding are advised to avoid using this drug, and safety and efficacy in children or adolescents under 18 years old have not been established. Elderly patients may have impaired kidney function, so regular kidney function tests before and after taking this drug are recommended. In cases of overdose, general treatment should be administered, and if necessary, the drug may be removed via hemodialysis. This drug has relatively few interactions with other medications, but it is advisable to consult with a doctor or pharmacist when taking certain medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infections
  • headache
  • constipation
  • vomiting
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • nausea
  • dyspepsia
  • dizziness
  • increased triglycerides in the blood
  • increased low-density lipoproteins
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This drug should be stored in a tightly sealed container to prevent air ingress, and it is important to maintain storage temperature between 1 and 30 degrees Celsius at room temperature. This will help ensure the drug's effectiveness is safely preserved for a long time.

Appearance and packaging

Appearance

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

Package unit

PTP - 28 tablets/box [(14 tablets/PTP×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.