Medication info
Sitadual XR Sustained Release Tablet 50/1000 mg (Sitagliptin Hydrochloride Hydrate, Metformin Hydrochloride)

Sitadual XR Sustained Release Tablet 50/1000 mg (Sitagliptin Hydrochloride Hydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Bright green oval sustained-release film-coated tablet
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300585 · Approved 2023.02.17 · Insurance code 642005000

Summary

Main use
Improvement of blood sugar control in Type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg sustained-release tablet should be taken once daily, 1 tablet at a time. Patients taking the 50/500 mg or 50/1000 mg sustained-release tablets should take 2 tablets together once daily. 1. For patients not currently treated with metformin: The initial dose should total 100 mg of sitagliptin and 1000 mg of metformin per day. If necessary, the metformin daily

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of blood sugar control in Type 2 diabetes

View approved original text

This medication is used to improve blood sugar control by assisting dietary and exercise therapy in patients with Type 2 diabetes. By combining sitagliptin and metformin, it effectively lowers blood sugar and aids in diabetes management. Patients may expect better treatment outcomes by consistently taking the medication along with lifestyle improvements.

How to take

Adult dose

The 100/1000 mg sustained-release tablet should be taken once daily, 1 tablet at a time. Patients taking the 50/500 mg or 50/1000 mg sustained-release tablets should take 2 tablets together once daily. 1. For patients not currently treated with metformin: The initial dose should total 100 mg of sitagliptin and 1000 mg of metformin per day. If necessary, the metformin daily

Precautions

This medication contains sitagliptin and metformin and is used to control blood sugar. First, severe allergic reactions may rarely occur during the usage of this medication, so if skin rash, difficulty breathing, or swelling of the face or lips occurs, you should stop taking the medication immediately and go to a hospital. Also, this medication may pose a risk of pancreatitis, an inflammation of the pancreas, so if abdominal pain, vomiting, or severe abdominal pain occurs, you need to inform medical personnel immediately. Due to the metformin component, a rare complication called lactic acidosis may occur, which could lead to a dangerous buildup of lactic acid in the body. Symptoms such as fatigue, muscle pain, difficulty breathing, and abdominal pain may present, necessitating caution. It is unsafe for patients with impaired kidney function, dehydration, severe infections, heart failure, acute myocardial infarction, or other certain conditions to take this medication. In particular, this medication should be temporarily stopped before and after undergoing tests using radioactive iodine contrast agents, and it should be restarted only after confirming that kidney function is normal. Women who are pregnant or may become pregnant, and those who are breastfeeding should not take this medication. Moreover, irregular meals or intense exercise, along with the use of certain medications, may increase the risk of hypoglycemia and lactic acidosis, so caution is required. This medication may cause side effects such as gastrointestinal disturbances, headaches, upper respiratory infections, and hypoglycemia; particularly, the risk of hypoglycemia may increase when taken with insulin or sulfonylureas. During treatment, it is necessary to regularly monitor kidney function and perform blood tests, as vitamin B12 levels may decrease, requiring supplementation if necessary. Alcohol can increase the risk of side effects from this medication, so excessive drinking should be avoided during treatment. If you are scheduled for surgery or in poor health due to severe infections or trauma, this medication should be temporarily stopped and resumed only after recovery. Finally, it is crucial to consult medical personnel immediately if any adverse symptoms occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rashes, Steven-Johnson syndrome and other exfoliative skin diseases, acute pancreatitis, acute kidney failure, elevated liver enzymes, bullous pemphigoid, thrombocytopenia, rhabdomyolysis, severe hypoglycemia, severe and disabling arthralgia

Mild side effects

  • Diarrhea
  • upper respiratory infections
  • headaches
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • muscle pain
  • limb pain
  • back pain
Show 4 more
  • pruritus
  • thrombocytopenia
  • severe and disabling arthralgia
  • rhabdomyolysis

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container when in use. Additionally, it should be kept at room temperature between 1°C and 30°C, avoiding extreme heat or cold for safe use.

Appearance and packaging

Appearance

Bright green oval sustained-release film-coated tablet

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.