Medication info

Samsung Sitagliptin Tablets 100 mg (Sitagliptin Phosphate Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Beige colored, round, double convex film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging * 2)
Approval status
Active

MFDS item code 201603960 · Approved 2016.06.27

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dosage of 100 mg for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. This medication can be taken regardless of meals. For patients with renal impairment, dose adjustments are necessary based on renal function. - Mild renal impairment (eGFR 60–90): No dose adjustment needed. - Moderate renal impairment (eGFR 45–60): No dose adjustment needed. - Moderate renal impairment

Ingredients

Manufacturer
삼성제약(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 in conjunction with dietary and exercise therapies to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone, and if blood sugar control is difficult with monotherapy or prior diabetes medications have not been used, it may be used in conjunction with metformin. Additionally, this medication is added when monotherapy with sulfonylureas, metformin, thiazolidinediones, or insulin does not adequately control blood sugar levels. If blood sugar control is difficult even with combination therapy, this medication can be added for treatment. Thus, this medication helps improve blood sugar control at various stages of treatment.

How to take

Adult dose

This medication is administered once daily at a dosage of 100 mg for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. This medication can be taken regardless of meals. For patients with renal impairment, dose adjustments are necessary based on renal function. - Mild renal impairment (eGFR 60–90): No dose adjustment needed. - Moderate renal impairment (eGFR 45–60): No dose adjustment needed. - Moderate renal impairment

Precautions

This medication may rarely cause serious allergic reactions, so if symptoms such as difficulty breathing, swelling of the face or neck, or skin rashes occur within three months after administration, usage should be discontinued immediately and a doctor consulted. During treatment with this medication, symptoms of pancreatitis such as sudden abdominal pain, nausea, and vomiting may occur; if these symptoms arise, inform medical personnel immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients who are hypersensitive to this drug or its components. Patients with kidney function impairment should have their dosing adjusted, particularly those with low glomerular filtration rates or those undergoing dialysis should strictly follow a doctor's instructions. While taking this medication, one should watch for hypoglycemic symptoms, and particularly in cases of co-administration with insulin or sulfonylureas, the risk of hypoglycemia may increase, so blood sugar should be monitored frequently. Side effects such as headaches, upper respiratory infections, nasopharyngitis, diarrhea, nausea, and dizziness may occur; if symptoms are severe, it is advisable to consult medical personnel. The use of this medication during pregnancy is not recommended, and it is also safer not to use during breastfeeding. In elderly patients, renal function may decline, therefore dosage adjustment and kidney function monitoring are necessary. In case of an overdose of this medication, immediate hospital visit for appropriate treatment and monitoring is required, and some can be removed through dialysis. During medication, if any abnormal symptoms such as joint pain or skin blisters occur, notify a doctor immediately, and if necessary, medication can be discontinued. Drug interactions are minimal; however, when taken alongside cyclosporine or digoxin, blood concentrations should be monitored. This medication does not significantly impact cardiovascular safety, but patients with existing cardiovascular diseases should have regular check-ups.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, severe skin reactions (Stevens-Johnson syndrome, exfoliative dermatitis), acute pancreatitis, difficulty breathing, severe and disabling joint pain, blistering pemphigoid, acute renal failure, jaundice, severe allergic reactions

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • constipation
  • vomiting
  • muscle pain
  • limb pain
  • back pain
  • itching
  • thrombocytopenia
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  • diarrhea
  • nausea
  • indigestion
  • dizziness
  • increased 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 sealed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to retain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Beige colored, round, double convex film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging * 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.

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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.