Medication info
Sitagliptin/Metformin Sustained Release Tablet 50/500 mg

Sitagliptin/Metformin Sustained Release Tablet 50/500 mg

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

MFDS item code 202201900 · Approved 2022.05.10 · Insurance code 642707310

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage for this sustained release form of the drug 100/1000 mg is 1 tablet once daily. For patients using the 50/500 mg or 50/1000 mg sustained release forms, 2 tablets are to be taken simultaneously once daily. 1. For patients not currently treated with metformin: The initial dosage is a total daily amount of sitagliptin 100 mg and metformin 1000 mg. If adequate blood sugar control is not achieved with the initial dosage, metformin may be gradually increased to its maximum recommended dose of 2000 mg while reducing the likelihood of gastrointestinal side effects.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in conjunction with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. The two ingredients, sitagliptin and metformin, work together to effectively manage blood glucose levels. This helps stabilize blood sugar levels and reduce the risk of complications. Therefore, this medication is used to enhance the treatment of patients with type 2 diabetes.

How to take

Adult dose

The dosage for this sustained release form of the drug 100/1000 mg is 1 tablet once daily. For patients using the 50/500 mg or 50/1000 mg sustained release forms, 2 tablets are to be taken simultaneously once daily. 1. For patients not currently treated with metformin: The initial dosage is a total daily amount of sitagliptin 100 mg and metformin 1000 mg. If adequate blood sugar control is not achieved with the initial dosage, metformin may be gradually increased to its maximum recommended dose of 2000 mg while reducing the likelihood of gastrointestinal side effects.

Precautions

This medication contains two components, sitagliptin and metformin, and is primarily used for the treatment of type 2 diabetes. First, while sitagliptin helps with blood sugar control, it can rarely cause severe allergic reactions. If symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur within 3 months of use, it is essential to stop using the medication immediately and consult a doctor. Also, sitagliptin can cause acute pancreatitis, so if symptoms like abdominal pain, vomiting, or severe indigestion occur, medication should be stopped immediately, and the patient should visit a hospital. Metformin has blood sugar-lowering effects but should not be administered to patients with severely impaired kidney function, dehydration, severe infections, or heart disease. Regular kidney function tests should be performed, particularly for these patients. This medication can pose a risk of lactic acidosis, a rare but life-threatening metabolic disorder. If symptoms such as sudden fatigue, muscle pain, difficulty breathing, abdominal pain, or confusion occur, the healthcare provider should be notified immediately. Excessive alcohol consumption can increase the risk of side effects from this medication, so alcohol should be avoided. Before surgery or radiological contrast examinations, patients should consult with their physician about temporarily discontinuing the medication and should resume it after kidney function has recovered. This medication should not be administered to pregnant or breastfeeding women, and its safety in individuals under 18 years of age has not been established. There is a risk of hypoglycemia while taking this medication, so especially if taken with other blood sugar-lowering agents, blood sugar levels should be checked frequently, and if unusual symptoms occur, the doctor should be consulted immediately. While taking this medication, regular blood tests and kidney function tests should be conducted to monitor for adverse reactions, and vitamin B12 levels may decrease, necessitating supplementation if required. Lastly, if an overdose of this medication is suspected, the patient should visit a hospital immediately for appropriate treatment, as some components may be removed by dialysis.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, rash, high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, anaphylaxis, angioedema, Stevens-Johnson syndrome, acute pancreatitis, acute renal failure, liver abnormalities (jaundice), elevated liver enzymes, severe neurological symptoms (severe headache, seizures, confusion, vision disturbances, paralysis), hypoxemia, severe edema accompanied by elevated blood pressure, acute

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • hypoglycemia
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • severe and disabling arthralgia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Bright blue, biconvex, oval-shaped sustained 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.