Medication info
SitaSingle Tablets 100 mg (Sitagliptin Hydrochloride Monohydrate)

SitaSingle Tablets 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.37mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Bright yellow-orange round film-coated tablets
Packaging
Bottle pack - 30 tablets/bottle, Bottle pack - 100 tablets/bottle
Approval status
Active

MFDS item code 202301821 · Approved 2023.06.14 · Insurance code 648604550

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is taken once daily at a dose of 100 mg, whether used alone or in combination, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments are necessary based on kidney function. - Mild renal impairment (eGFR 60 to 90 mL/min/1.73 m2): No dosage adjustment needed. - Moderate renal impairment (eGFR 45 to 60 mL/min/1.73 m2): Dosage adjustment is necessary.

Ingredients

Manufacturer
(주)씨엠지제약

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 improve blood sugar control in patients with type 2 diabetes. It can be administered as monotherapy when starting treatment with diabetes medications. However, if blood sugar control is insufficient with monotherapy, it may be used in combination with metformin. Additionally, this medication can be used in conjunction with other diabetes treatments such as sulfonylureas, thiazolidinediones, or insulin if blood sugar control is challenging, even when used alone or together with these treatments. This medication effectively helps manage blood sugar levels in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

This medication is taken once daily at a dose of 100 mg, whether used alone or in combination, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments are necessary based on kidney function. - Mild renal impairment (eGFR 60 to 90 mL/min/1.73 m2): No dosage adjustment needed. - Moderate renal impairment (eGFR 45 to 60 mL/min/1.73 m2): Dosage adjustment is necessary.

Precautions

This medication may cause severe allergic reactions after administration. These reactions may include anaphylaxis, angioedema, and serious skin diseases. If such symptoms are suspected, immediately discontinue the medication and consult a physician. This medication can cause inflammation of the pancreas; therefore, if symptoms of pancreatitis such as abdominal pain, vomiting, or loss of appetite occur while on this medication, medical personnel should be informed immediately. Medication should be discontinued if necessary. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Additionally, patients with allergies to this medication or its components should avoid its use. Patients with impaired kidney function may have delayed excretion of this medication; hence, dosage adjustments should be made with caution. Especially patients with low glomerular filtration rates or those undergoing dialysis must strictly follow a physician's instructions. In clinical trials, this medication may cause hypoglycemic symptoms when used alone or in combination with other diabetes medications. The risk of hypoglycemia increases when taken with insulin or sulfonylureas, so blood sugar levels should be closely monitored. While taking this medication, symptoms such as headaches, upper respiratory infections, nasopharyngitis, diarrhea, and nausea may occur. If these symptoms persist or worsen, consult medical personnel. Serious side effects such as severe arthralgia or skin blistering conditions like bullous pemphigoid have been reported; if such symptoms occur, discontinue the medication immediately and consult a specialist. This medication is not recommended for pregnant women and should be avoided by breastfeeding women as well. Safety and efficacy in children under 18 have not been established. Elderly patients may have a risk of reduced kidney function; hence, dosage adjustments and regular monitoring of kidney function are necessary. In the case of overdose, the medication should be cleared from the gastrointestinal tract, and clinical conditions including cardiac function should be carefully monitored, and blood dialysis may be performed to remove some of the medication as needed.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome and other exfoliative skin disorders, severe skin adverse reactions, severe and debilitating arthralgia, bullous pemphigoid, acute pancreatitis, acute renal failure, elevated liver enzyme levels (caution when suspecting liver abnormalities or jaundice), severe edema accompanying hypertension, serious neurological symptoms (confusion, seizures, etc.), hypoglycemia (severe)

Mild side effects

Upper respiratory infection, nasopharyngitis, headache, dyspepsia, dizziness, diarrhea, nausea, abdominal pain, constipation, myalgia, limb pain, back pain, pruritus, thrombocytopenia, increased serum triglycerides, hypernatremia, erectile dysfunction, increased low-density lipoprotein cholesterol, hyperglycemia, elevated ALT, elevated AST

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 or moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablets

Package unit

Bottle pack - 30 tablets/bottle, Bottle pack - 100 tablets/bottle

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.