Medication info

Metformin Citrate 50/500 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›Strength being verifiedMetformin Hydrochloride›Strength being verified
Manufacturer / importer
광동제약(주)
Appearance
Pink oval film-coated tablet
Packaging
Company packaging unit
Approval status
Approval withdrawn

MFDS item code 201506301 · Approved 2015.09.01

This product's status changed to Approval withdrawn on 2023.07.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is generally taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal adverse reactions attributed to metformin. 1. Patients not currently treated with metformin: Start with this medication 50/500 mg taken twice daily, 1 tablet per dose, and it may be increased to 50/1000 mg taken twice daily, 1 tablet per dose. 2. Patients currently receiving metformin treatment

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Blood sugar regulation disorders in patients with type 2 diabetes
View approved original text

This medication is used in conjunction with diet and exercise to assist in blood sugar control for patients with type 2 diabetes. It is especially beneficial for those who have not previously experienced diabetes medication treatment and find it difficult to control blood sugar with monotherapy. Additionally, it is used when metformin or sitagliptin monotherapy is insufficiently effective, or as an alternative to combination therapy with both drugs. This medication is also used to enhance treatment efficacy when blood sugar control is difficult despite the use of metformin in combination with sulfonylureas, thiazolidinediones, or insulin. It is an important therapeutic agent used in various cases to improve blood sugar control.

Dosage and Administration

Adult dosage

This medication is generally taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal adverse reactions attributed to metformin. 1. Patients not currently treated with metformin: Start with this medication 50/500 mg taken twice daily, 1 tablet per dose, and it may be increased to 50/1000 mg taken twice daily, 1 tablet per dose. 2. Patients currently receiving metformin treatment

Precautions

This medication is used for the treatment of diabetes and helps in controlling blood sugar. During treatment, serious allergic reactions may occur. If symptoms such as skin rash or difficulty breathing occur, it is essential to stop taking the medication immediately and consult a doctor. There is a risk of acute pancreatitis, an inflammation of the pancreas, so if symptoms such as abdominal pain, vomiting, or nausea occur, visit a hospital immediately. Patients with impaired kidney function, severe infections, or dehydration should not take this medication. It is also contraindicated in patients with severe heart diseases such as severe heart failure or acute myocardial infarction, as well as in pregnant or breastfeeding women. Care is required when there are irregular meals, vigorous exercise, or concomitant use with other medications, as side effects such as hypoglycemia or lactic acidosis may occur. This medication may cause side effects such as gastrointestinal disturbances, headaches, upper respiratory infections, and hypoglycemic symptoms may also be observed. When taken with other hypoglycemic agents, the risk of hypoglycemia may increase, so blood sugar levels should be monitored closely. Since this medication is excreted by the kidneys, regular kidney function tests must be performed, and dosage adjustment or discontinuation may be necessary in cases of decreased kidney function. Moreover, it may lower vitamin B12 levels, so it is advisable to check this through regular blood tests. Excessive alcohol consumption can increase the risk of side effects associated with this medication, so it is better to avoid drinking alcohol. Patients scheduled for surgery should stop taking this medication 48 hours prior to the surgery and can resume after surgery when kidney function has been confirmed to be normal. Elderly patients are at increased risk of decreased kidney function, so they should be especially cautious in their use and undergo regular kidney function tests. In case of overdose, seek immediate medical attention, as this medication can be partially removed through hemodialysis. During the use of this medication, regular checks for blood sugar, kidney function, and blood tests should be done, and if abnormal symptoms appear, consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • rash
  • Stevens-Johnson syndrome
  • exfoliative skin disease
  • severe rash accompanied by fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
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  • difficulty breathing
  • acute pancreatitis
  • acute renal failure
  • liver abnormalities (jaundice)
  • severe swelling
  • severe lactic acidosis
  • severe hypoglycemia
  • extreme hypoglycemia
  • severe headache
  • thunderclap headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • unstable angina

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
Show 10 more
  • back pain
  • pruritus
  • thrombocytopenia
  • decreased appetite
  • itching
  • dizziness
  • hypoglycemia
  • decreased vitamin B12
  • arthralgia
  • bullous pemphigoid

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

Storage

This medication should be stored in a tightly sealed container to prevent air from entering and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

Company packaging unit

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.