Medication info
Metformin Tablet (Metformin Hydrochloride)

Metformin Tablet (Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
White round film-coated tablet
Packaging
100 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200301790 · Notified 2003.12.24 · Insurance code 653800580

Summary

Main use
Improvement of Type 2 Diabetes (blood sugar control)
Who takes it
Adults · Children
Adult dose
The dosage should be determined based on the drug's effect and tolerance for each individual, not exceeding the recommended maximum daily dosage. This medication should be initiated at a low dose to reduce gastrointestinal side effects and to establish the minimum effective dose needed for adequate blood sugar control, dosed 500 mg three times daily with meals. The increase in dosage should be gradual, adding 500 mg each week, up to 20.
Child dose
For children aged 10 years and over or adolescents, the general starting dose is 500 milligrams once daily, to be taken during or after meals. One week later, blood sugar levels should be measured to adjust the dosage.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Improvement of Type 2 Diabetes (blood sugar control)

  • Type 2 diabetes
View approved original text

This medication is used for the treatment of patients with Type 2 diabetes whose blood sugar control is insufficient with diet and exercise alone. It is particularly effective in overweight adult patients and can be used as monotherapy or in combination with other oral hypoglycemic agents or insulin. Additionally, it can be used in children aged 10 years and over as monotherapy or together with insulin, aiding in diabetes management regardless of age. This medication is used to effectively control blood sugar, improving and managing the symptoms of diabetes.

How to take

Adult dose

The dosage should be determined based on the drug's effect and tolerance for each individual, not exceeding the recommended maximum daily dosage. This medication should be initiated at a low dose to reduce gastrointestinal side effects and to establish the minimum effective dose needed for adequate blood sugar control, dosed 500 mg three times daily with meals. The increase in dosage should be gradual, adding 500 mg each week, up to 20.

Child dose

For children aged 10 years and over or adolescents, the general starting dose is 500 milligrams once daily, to be taken during or after meals. One week later, blood sugar levels should be measured to adjust the dosage.

Precautions

This medication can cause severe lactic acidosis or hypoglycemia, so if these symptoms occur, immediate consultation with a healthcare professional is necessary. It should not be administered to patients with moderate to severe renal impairment or those in acute conditions such as dehydration, serious infections, or acute myocardial infarction. It is also not safe to use in patients with acute and unstable heart failure. Before and after examinations using iodinated contrast media, the administration of this medication should be temporarily suspended, and it should be restarted only after renal function has normalized. Patients allergic to this drug or other biguanides should avoid its use. Insulin treatment is necessary for patients with Type 1 diabetes or diabetic ketoacidosis, as this medication is not appropriate for them. Following severe infections or major trauma, the administration of this medication should be temporarily suspended until oral intake becomes possible. Scheduled surgical patients should also stop this medication 48 hours before surgery and resume it only after renal function is confirmed to be normal. Patients who are malnourished or frail, as well as those with pituitary or adrenal insufficiency, should use this product cautiously. Patients with liver dysfunction, severe pulmonary dysfunction, or those who consume excessive alcohol should avoid this medication. Patients with irregular meals or engaging in vigorous exercise, or those who may have interactions with other medications, should be administered this medication with caution. This medication commonly causes gastrointestinal side effects, which may initially include diarrhea, nausea, vomiting, etc., but these are mostly transient. Lactic acidosis is a very rare but dangerous side effect; if symptoms such as weakness, muscle pain, difficulty breathing, or abdominal pain occur, immediate discontinuation of treatment and notification of healthcare professionals is required. Regular renal function tests should be performed to prevent drug accumulation, and elderly patients or those with renal impairment should be particularly cautious. Since alcohol intake can increase the risk of lactic acidosis, excessive drinking should be avoided while taking this medication. B12 vitamin deficiency can occur, so regular monitoring of serum vitamin B12 levels is recommended. During pregnancy, there may be effects on the fetus; therefore, those planning to become pregnant or who are pregnant should consult a physician. In breastfeeding cases, this medication is secreted in breast milk; thus, the decision to continue breastfeeding should be made in consultation with a physician. Interactions may occur with other antidiabetic agents or various medications, so any other medications taken must be reported to healthcare professionals. In case of overdose, blood dialysis may be required, so it is essential to adhere strictly to the prescribed dosage and seek immediate medical attention for any abnormal symptoms. This medication helps control blood sugar without weight gain; however, regular monitoring of blood glucose and renal function tests is necessary to confirm treatment efficacy and safety.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis (including muscle pain, fatigue, difficulty breathing, weakness, abdominal pain, low temperature, low blood pressure, and arrhythmias), severe edema, severe allergic reactions (hives, significant swelling, chest tightness, difficulty breathing, cold sweat, paleness), severe skin reactions (severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, cough associated with fever), liver abnormalities.

Mild side effects

Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal distension, loss of appetite, dyspepsia, constipation, abdominal pain), metallic taste, rash, anemia, leukopenia, thrombocytopenia, vitamin B12 deficiency, liver function abnormalities, delayed hypoglycemia, nonspecific gastrointestinal symptoms, risk of hypoglycemia, weight changes, etc.

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 exposure, at room temperature between 1 to 30 degrees Celsius. This will help to maintain the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

100 tablets/bottle, 500 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.