Medication info

Sitagliptin 100 mg Tablets (Sitagliptin Phosphate Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Beige, round, biconvex film-coated tablets
Packaging
28 tablets/PTP
Approval status
Expired

MFDS item code 201503238 · Approved 2015.05.28

This product's status changed to Expired on 2025.05.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
For monotherapy or combination therapy, the recommended dosage is 100 mg once daily, with a maximum daily dose of 100 mg. For patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (eGFR 60–90 mL/min/1.73 m2): no dosage adjustment necessary - Moderate renal impairment (eGFR 45–60 mL/min/1.73 m2): no dosage adjustment necessary - Moderate renal impairment

Ingredients

Manufacturer
대우제약(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 diet and exercise to assist in blood sugar control in patients with type 2 diabetes. It can be administered alone to patients who are being treated for the first time. If blood sugar control is difficult with monotherapy, it is combined with metformin. Additionally, if there is insufficient effect with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this drug can be added. When it is difficult to control blood sugar even when using multiple medications together, adding this medication can enhance the therapeutic effect. It is used in various situations to improve blood sugar control.

How to take

Adult dose

For monotherapy or combination therapy, the recommended dosage is 100 mg once daily, with a maximum daily dose of 100 mg. For patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (eGFR 60–90 mL/min/1.73 m2): no dosage adjustment necessary - Moderate renal impairment (eGFR 45–60 mL/min/1.73 m2): no dosage adjustment necessary - Moderate renal impairment

Precautions

This medication is used to treat diabetes and helps to control blood sugar. The most important caution while taking this medication is that allergic reactions may occur. Some patients may experience serious allergic reactions such as anaphylaxis, angioedema, or severe skin conditions, so if symptoms like rash or difficulty breathing occur within three months of taking it, use should be stopped immediately and a medical consultation should be sought. Moreover, this medication can cause a condition called pancreatitis, which is inflammation of the pancreas; therefore, if symptoms such as abdominal pain, nausea, or vomiting indicating pancreatitis occur, the medication should be discontinued immediately and medical consultation should be obtained. Patients with type 1 diabetes, diabetic ketoacidosis, or those with a history of severe allergic reactions to this drug or its components should not take this medication. Patients with impaired kidney function may have delayed excretion of this medication, thus dosage adjustment is necessary, and regular kidney function tests should be conducted before and during treatment. Side effects that may occur when taking this medication alone or in combination with other diabetes medications include upper respiratory infections, nasopharyngitis, headache, and diarrhea. Particularly, when taken with sulfonylureas or insulin, the risk of hypoglycemia may increase, so blood sugar levels should be monitored carefully. Pregnant or breastfeeding women are advised against using this medication, and safety and effectiveness in pediatric patients under 18 have not been established. Elderly patients may have a higher likelihood of reduced kidney function, thus dosage adjustments and monitoring of kidney function are necessary. In case of overdose, general symptomatic treatment is recommended, and if necessary, some medications can be removed by hemodialysis. This medication has relatively low risk of interactions with other drugs; however, caution is necessary when taken together with cyclosporine or digoxin, so all medications being taken should be disclosed to healthcare personnel. Finally, if joint pain or skin blisters occur during the use of this medication, inform healthcare personnel immediately, and consider stopping the medication if these symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, Stevens-Johnson syndrome, skin rash, skin peeling, pain in oral/eye mucosa, pancreatitis, acute pancreatitis, acute renal failure, severe allergic reactions, severe and disabling joint pain, blistering erythema, jaundice (liver dysfunction), severe edema, hypoglycemia (including confusion of consciousness and seizures), severe neurological symptoms (confusion of consciousness, seizures, visual disturbances, paralysis), pneumonia

Mild side effects

Upper respiratory infection, nasopharyngitis, constipation, vomiting, headache, muscle pain, limb pain, back pain, pruritus, thrombocytopenia, diarrhea, abdominal pain, nausea, dyspepsia, dizziness, increased blood triglycerides, increased low-density lipoprotein cholesterol, 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 closed container to prevent exposure to air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Beige, round, biconvex film-coated tablets

Package unit

28 tablets/PTP

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.