Medication info
Sinubi MXR Extended-Release Tablets 50/1000 mg (Sitagliptin, Metformin)

Sinubi MXR Extended-Release Tablets 50/1000 mg (Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Bright green, bilaterally convex, oval-shaped extended-release film-coated tablets
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202201965 · Approved 2022.05.11 · Insurance code 647805480

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg extended-release tablets should be taken once daily, 1 tablet at a time. Patients taking the 50/500 mg extended-release tablets or the 50/1000 mg extended-release tablets should take 2 tablets at once, once daily. 1. For patients not currently treated with Metformin: The initial dosage is a total daily amount of 100 mg Sitagliptin and 1000 mg Metformin, and if necessary, Metformin can be increased to 1 day

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is used to assist patients with type 2 diabetes in managing their blood sugar levels. It is particularly effective in conjunction with dietary and exercise therapies, as Sitagliptin and Metformin work together to improve blood sugar levels. This medication can lead to better blood sugar control for those who have difficulty managing their blood sugar.

How to take

Adult dose

The 100/1000 mg extended-release tablets should be taken once daily, 1 tablet at a time. Patients taking the 50/500 mg extended-release tablets or the 50/1000 mg extended-release tablets should take 2 tablets at once, once daily. 1. For patients not currently treated with Metformin: The initial dosage is a total daily amount of 100 mg Sitagliptin and 1000 mg Metformin, and if necessary, Metformin can be increased to 1 day

Precautions

This medication is an antidiabetic treatment that combines Sitagliptin and Metformin to assist in blood sugar control. Firstly, the Sitagliptin component can cause allergic reactions; therefore, if symptoms such as skin rash, hives, or shortness of breath occur, discontinue use immediately and consult a healthcare professional. Additionally, there is a risk of acute pancreatitis, which can manifest as abdominal pain, nausea, or vomiting; thus, immediate medical attention is necessary if these symptoms arise. The Metformin component may rarely cause a serious metabolic disorder known as lactic acidosis, which can present with non-specific symptoms like muscle pain, difficulty in breathing, fatigue, and abdominal pain, so any such symptoms should be reported to a healthcare professional immediately. This medication should not be administered to patients with impaired kidney function, those with acute heart failure or myocardial infarction, patients with severe liver dysfunction, pregnant women or women of childbearing potential, and nursing mothers. Additionally, patients scheduled for surgery or those who have recently received radiological contrast agents should temporarily discontinue this medication and ensure kidney function tests are conducted before resuming treatment. Regular monitoring of kidney function and blood tests should be conducted during treatment, especially for elderly patients or those with diminished kidney function. Symptoms of hypoglycemia may occur; therefore, meals should not be skipped, and adjustments to medication dosages may be necessary when taken with other hypoglycemic agents or insulin to reduce the risk of hypoglycemia. Alcohol consumption may increase the risk of lactic acidosis, so it is advisable to avoid drinking alcohol while on this medication. Finally, if there are any blisters or rashes on the skin while taking this medication, inform a healthcare professional immediately and seek appropriate treatment. This medication is not recommended for use in children or adolescents under the age of 18 due to the lack of established safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, exfoliative skin diseases (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, elevated liver enzymes, thrombocytopenia, rhabdomyolysis, severe lactic acidosis, hypoglycemia (in severe cases), acute and severe skin adverse reactions, acute respiratory distress, severe edema, liver abnormalities (jaundice), severe neurological symptoms, acute pancreatitis, blistering dermatosis

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nasopharyngitis
  • nausea
  • vomiting
  • abdominal pain
  • muscle pain
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • constipation
  • severe joint pain with disability
  • blistering dermatosis

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

Storage

This medication can be sensitive to air and moisture, hence it should be stored tightly sealed in a container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way helps preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright green, bilaterally convex, oval-shaped extended-release film-coated tablets

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.

Questions about this medicine

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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.