Medication info
Sitamon Tablet 100 mg (Sitagliptin Hydrochloride Hydrate)

Sitamon Tablet 100 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
A bright brown, round, biconvex film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP * 2]
Approval status
Active

MFDS item code 202101851 · Approved 2021.02.24 · Insurance code 642906740

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered once daily at a dose of 100 mg for both monotherapy and combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, no dosage adjustment is needed for mild to moderate renal impairment (glomerular filtration rate 45 mL/min/1.73 m2 to less than 60). In cases of moderate renal impairment (glomerular filtration rate 30 to less than 45), a dosage of 50 mg once daily is recommended.

Ingredients

Manufacturer
일동제약(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 is used as an adjunct to diet and exercise to help control blood sugar in patients with type 2 diabetes. It can be administered as monotherapy, and in cases where sufficient blood sugar control is not achievable alone, it can be combined with metformin. Additionally, it is also used in conjunction with sulfonylureas, metformin, thiazolidinediones, or insulin when blood sugar control is inadequate with these treatments. If blood sugar control remains difficult when using any combination of sulfonylureas and metformin, thiazolidinediones and metformin, or insulin and metformin, this drug may be added to the regimen. It helps improve blood sugar control at various stages of treatment.

Dosage and Administration

Adult dosage

This medication is administered once daily at a dose of 100 mg for both monotherapy and combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, no dosage adjustment is needed for mild to moderate renal impairment (glomerular filtration rate 45 mL/min/1.73 m2 to less than 60). In cases of moderate renal impairment (glomerular filtration rate 30 to less than 45), a dosage of 50 mg once daily is recommended.

Precautions

This medication can cause severe allergic reactions; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after administration, discontinue use immediately and consult a physician. While taking this medication, serious symptoms of pancreatitis may occur, so if symptoms like abdominal pain, vomiting, or loss of appetite develop, seek medical attention promptly. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Patients allergic to this medication or its components should not take it. Patients with impaired kidney function may need to adjust their dosage of this medication, especially those with severe renal impairment, who should be treated at a lower dose. During treatment, mild adverse reactions such as general cold symptoms, headaches, and nasopharyngitis may occur. When taken with other blood sugar-lowering agents, particularly insulin or sulfonylureas, hypoglycemia may appear, requiring regular blood sugar monitoring and dosage adjustments as necessary. This medication can trigger severe joint pain or skin blistering disorders, so if these symptoms appear, inform a doctor immediately and discontinue use of the medication. It is advisable for pregnant or nursing women to avoid this medication, and safety in children and adolescents under 18 years has not been established. Elderly patients may have reduced kidney function, making dosage adjustment and renal function testing important. In cases of overdose, general emergency treatment is warranted, and in some instances, dialysis may be necessary to remove some of the medication. This medication has a low potential for interaction with other drugs, but caution is required when using it with certain medications, so consult a doctor or pharmacist about other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, severe allergic reactions, exfoliative skin diseases including Stevens-Johnson syndrome, severe joint pain with disability, blistering similar to pemphigus, acute pancreatitis, elevated liver enzymes, acute renal failure, difficulty breathing, cardiac arrest, pneumonia, diabetic complications, metabolic acidosis, severe edema, hypoglycemia (severe and requiring treatment)

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • muscle pain
  • limb pain
  • back pain
  • dyspepsia
  • dizziness
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  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction
  • increased triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • increased serum creatinine
  • thrombocytopenia

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 and moisture, and should be kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

A bright brown, round, biconvex film-coated tablet

Package unit

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.