Medication info
Sitadual XR Extended-Release Tablet 50/500 mg (Sitagliptin Hydrate, Metformin Hydrochloride)

Sitadual XR Extended-Release Tablet 50/500 mg (Sitagliptin Hydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Light blue, oval-shaped, bi-convex extended-release film-coated tablets
Packaging
Bottle - 100 tablets/bottle, bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300584 · Approved 2023.02.17 · Insurance code 642004990

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions caused by metformin, with gradual dose increases. To maintain the extended-release characteristic, swallow whole without splitting, crushing, chewing, or dissolving. The 100/1000 mg extended-release tablet is taken once daily, with 1 tablet per dose. The 50/500 mg or 50/1000 mg extended-release tablet is taken once daily, with 2 tablets per dose.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is used in conjunction with diet and exercise therapy for patients with type 2 diabetes to help control blood sugar levels. The two active ingredients, sitagliptin and metformin, work together to effectively lower and regulate blood sugar levels. This allows for more efficient management of blood sugar and may contribute to the prevention of complications related to diabetes. Therefore, consistent use along with lifestyle improvements will greatly aid in blood sugar control.

How to take

Adult dose

This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions caused by metformin, with gradual dose increases. To maintain the extended-release characteristic, swallow whole without splitting, crushing, chewing, or dissolving. The 100/1000 mg extended-release tablet is taken once daily, with 1 tablet per dose. The 50/500 mg or 50/1000 mg extended-release tablet is taken once daily, with 2 tablets per dose.

Precautions

This medication contains two ingredients for the treatment of diabetes. The first ingredient helps in regulating blood sugar, while the second ingredient is effective at lowering blood sugar. The most important point while taking this medication is to be cautious of allergic reactions. Rarely, severe allergic reactions or skin conditions may occur, so if symptoms such as skin rash, itching, or difficulty breathing arise, stop taking the medication immediately and consult a physician. Additionally, there is a risk of pancreatitis, which involves inflammation of the pancreas, so if symptoms such as abdominal pain, vomiting, or fever occur, inform medical personnel immediately. It is also recommended to avoid this medication in patients with poor kidney function, dehydration, serious infections, or heart disease for safety. Patients with reduced kidney function should consult a physician before taking this medication and undergo regular kidney function tests. Pregnant or nursing women should not take this medication, and safety and efficacy have not been established in children under 18 years of age. During treatment, be mindful that irregular meals, excessive exercise, or other medications may cause hypoglycemia. Particularly, when taken with insulin or sulfonylureas, the risk of hypoglycemia may increase, so it is important to monitor blood sugar levels frequently. Alcohol consumption should be avoided while taking this medication, as acute alcohol intoxication or impaired liver function may cause severe side effects such as lactic acidosis. Stop taking this medication temporarily if undergoing surgery or tests that use contrast agents, and the decision to resume should be based on kidney function test results. This medication may decrease vitamin B12 levels, so if taking it long-term, it is advisable to check vitamin B12 status regularly through blood tests. Finally, in the case of an overdose, immediately seek medical attention for appropriate treatment, as some ingredients can be removed by dialysis. As this medication has various precautions and side effects, it is essential to consult with a physician or pharmacist before taking it and follow their instructions.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, exfoliative skin disease (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, hypoglycemia (including severe), elevated liver enzymes, bullous pemphigoid, thrombocytopenia, rhabdomyolysis, lactic acidosis, severe and debilitating joint pain, severe allergic reactions, severe skin adverse reactions, liver abnormalities (jaundice), severe swelling or urinary abnormalities, respiratory issues, severe neurological symptoms

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nasopharyngitis
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • joint pain
  • muscle pain
Show 3 more
  • limb pain
  • back pain
  • pruritus

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

Storage

Store this medication in a sealed container as it is sensitive to air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Light blue, oval-shaped, bi-convex extended-release film-coated tablets

Package unit

Bottle - 100 tablets/bottle, bottle - 30 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.