Medication info
Sitagliptin and Metformin Extended-Release Tablets 50/500 mg

Sitagliptin and Metformin Extended-Release Tablets 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Light blue, oval-shaped, biconvex, extended-release film-coated tablet
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202201876 · Approved 2022.05.09 · Insurance code 653806190

Summary

Main use
Improved blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication should be taken once daily with dinner to reduce gastrointestinal adverse reactions associated with metformin, with gradual dose escalation recommended. To maintain its extended-release properties, the tablet should not be split, crushed, ground, or chewed but swallowed whole. The extended-release 100/1000 mg tablet is taken once daily, with a dosage of 1 tablet. Patients taking the 50/500 mg or 50/1000 mg extended-release tablets should take 2 tablets once daily.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improved blood sugar control in type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with type 2 diabetes through the combination of sitagliptin and metformin. It is effective when used alongside dietary and exercise therapy, contributing to the stable management of blood sugar levels and the prevention of complications. Therefore, it is used for the treatment of patients with type 2 diabetes.

How to take

Adult dose

This medication should be taken once daily with dinner to reduce gastrointestinal adverse reactions associated with metformin, with gradual dose escalation recommended. To maintain its extended-release properties, the tablet should not be split, crushed, ground, or chewed but swallowed whole. The extended-release 100/1000 mg tablet is taken once daily, with a dosage of 1 tablet. Patients taking the 50/500 mg or 50/1000 mg extended-release tablets should take 2 tablets once daily.

Precautions

This medication is composed of two active ingredients, sitagliptin and metformin, and is primarily used to assist in blood sugar control in patients with type 2 diabetes. First, sitagliptin may rarely cause severe allergic reactions; therefore, if symptoms like rash, hives, or difficulty breathing occur, the medication should be discontinued immediately and a doctor consulted. Additionally, serious side effects such as acute pancreatitis, which is inflammation of the pancreas, have been reported, so if abdominal pain, vomiting, or severe abdominal discomfort occur, prompt medical attention should be sought. The metformin component can cause lactic acidosis, a rare but potentially fatal metabolic disorder, and should not be taken by patients with impaired renal function, severe infections, dehydration, or liver diseases. Excessive alcohol intake may increase the risk of lactic acidosis, so it should be avoided while taking this medication. This medication should not be used in patients with reduced renal function, acute heart failure, or acute myocardial infarction, nor in women who are pregnant or breastfeeding, or in patients under 18 years of age. Regular tests of renal function and blood tests should be conducted while using this medication, and vitamin B12 levels should also be monitored periodically. Additionally, there is a risk of hypoglycemia, so caution should be exercised with irregular meals or intense exercise, and the risk of hypoglycemia should be more closely monitored when taken with insulin or other blood glucose-lowering agents. Before and after surgery or the use of iodine contrast agents for examinations, this medication should be temporarily discontinued and resumed only after confirming normal kidney function. Finally, if severe joint pain or skin blisters occur during the use of this medication, the physician should be notified immediately, and discontinuation of the drug may be required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, Stevens-Johnson syndrome, exfoliative skin disorders, fatal or non-fatal hemorrhagic pancreatitis, necrotizing pancreatitis, acute renal failure, severe hypoglycemia, severe lactic acidosis, acute liver dysfunction (symptoms of jaundice), bullous pemphigoid, severe arthralgia with disability

Mild side effects

  • Upper respiratory tract infections
  • nasopharyngitis
  • diarrhea
  • nausea
  • vomiting
  • headache
  • abdominal pain
  • myalgia
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • arthralgia

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

Storage

This medication should be kept in a tightly sealed container to protect it from air and moisture, and should be stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Light blue, oval-shaped, biconvex, extended-release film-coated tablet

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.