Medication info
Sitacombi XR Tablet 100/1000 mg

Sitacombi XR Tablet 100/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Bright blue oval-shaped extended-release film-coated tablet with convex sides
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202201884 · Approved 2022.05.09 · Insurance code 642906770

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg extended-release tablet should be taken once daily at a dose of 1 tablet. Patients taking the 50/500 mg extended-release or 50/1000 mg extended-release tablets should take 2 tablets at once once daily. 1. For patients not currently treated with metformin: The initial dose of this medication is sitagliptin 100 mg and metformin 1000 mg, in total once daily. Dosage should be gradually increased as needed.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It works by combining the effects of sitagliptin and metformin to complement dietary changes and exercise therapy. This allows for more effective control of blood sugar levels and assists in diabetes management. Patients can expect better treatment outcomes when consistently taking the medication and improving their lifestyle. In summary, this medication is used in the treatment of type 2 diabetes.

How to take

Adult dose

The 100/1000 mg extended-release tablet should be taken once daily at a dose of 1 tablet. Patients taking the 50/500 mg extended-release or 50/1000 mg extended-release tablets should take 2 tablets at once once daily. 1. For patients not currently treated with metformin: The initial dose of this medication is sitagliptin 100 mg and metformin 1000 mg, in total once daily. Dosage should be gradually increased as needed.

Precautions

This medication contains both sitagliptin and metformin and is used for the treatment of type 2 diabetes. Firstly, the sitagliptin component can rarely cause severe allergic reactions such as anaphylaxis, angioedema, and serious skin conditions, so if any of these symptoms appear within 3 months of administration, use must be stopped immediately, and a doctor should be consulted. Additionally, sitagliptin carries a risk of inducing acute pancreatitis, and if symptoms such as abdominal pain, nausea, or vomiting occur, the medication should be discontinued immediately and medical attention sought. The metformin component can rarely lead to a serious side effect known as lactic acidosis, so it should not be used in patients with impaired kidney function, liver dysfunction, severe infections, or dehydration, especially in patients with reduced kidney function. This medication is contraindicated for patients with moderate to severe renal impairment, acute heart failure, acute myocardial infarction, severe infections and dehydration, pregnant or nursing women, and individuals with type 1 diabetes. During treatment, it is important to regularly monitor kidney function, and if sudden dehydration or deterioration of kidney function is suspected, administration should be stopped immediately. Furthermore, it is important to avoid alcohol consumption during treatment as it can increase the risk of lactic acidosis. Before and after surgery, this medication should be temporarily discontinued, and it can be resumed once the patient's oral intake and kidney function have returned to normal. This medication can cause hypoglycemia, so blood sugar levels should be carefully monitored, particularly if taken with insulin or sulfonylureas, which may require dosage adjustments. During treatment, side effects such as diarrhea, nausea, vomiting, abdominal pain, headache, and upper respiratory infections may occur, and if symptoms are severe or persistent, consultation with a physician is advised. This medication is not recommended for children (under 18 years) as its safety and effectiveness have not been established. Elderly patients may experience decreased kidney function, so it is advisable to regularly assess kidney function and to start at the lowest effective dose when taking this medication. Finally, regular blood tests, kidney function examinations, and vitamin B12 level assessments are important to monitor health while on this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, severe allergic reactions, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, Stevens-Johnson syndrome, severe dermatological reactions, shortness of breath or difficulty breathing, asthma attacks, dyspnea with cough and fever, liver abnormalities (jaundice), yellowing of the skin or eyes, generalized malaise, acute pancreatitis.

Mild side effects

Diarrhea, nausea, vomiting, abdominal pain, upper respiratory infection, nasopharyngitis, headache, hypoglycemia, myalgia, limb pain, back pain, pruritus, thrombocytopenia, rhabdomyolysis, increased serum creatinine, decreased vitamin B12, peripheral edema, severe and disabling arthralgia, blistering dermatitis resembling pemphigus.

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

Storage

This medication should be stored in a tightly closed container to protect from air and moisture, at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and ensure safe use.

Appearance and packaging

Appearance

Bright blue oval-shaped extended-release film-coated tablet with convex sides

Package unit

28 tablets/bottle, 56 tablets/bottle, 200 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.