Medication info

Megaglime Tablet 2/500 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Glimepiride›2mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
White, oblong film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202000590 · Approved 2020.02.04

This product's status changed to Approval withdrawn on 2024.07.02. 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 takes it
Adults
Adult dose
This medication is administered 1 to 2 times a day before meals or with meals. The dosage may be adjusted considering each patient's current therapy, efficacy, and tolerability, which requires appropriate blood sugar monitoring. Normally, treatment is initiated with a low dose, and the dosage can be adjusted based on the patient's current medication and blood sugar levels. In clinical trials, the initial daily dose was Glimepiride/Metformin Hydrochloride 2 mg/500 mg.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Insulin-independent diabetes
View approved original text

This medication can be used by patients with insulin-independent diabetes, specifically type 2 diabetes, along with dietary and exercise therapy. It is particularly helpful when blood sugar control is insufficient with glimepiride or metformin monotherapy. It can also be used as a treatment alternative to the combination therapy of glimepiride and metformin. This medication helps in effectively controlling blood sugar levels, thereby improving the diabetic condition.

How to take

Adult dose

This medication is administered 1 to 2 times a day before meals or with meals. The dosage may be adjusted considering each patient's current therapy, efficacy, and tolerability, which requires appropriate blood sugar monitoring. Normally, treatment is initiated with a low dose, and the dosage can be adjusted based on the patient's current medication and blood sugar levels. In clinical trials, the initial daily dose was Glimepiride/Metformin Hydrochloride 2 mg/500 mg.

Precautions

This medication can cause severe lactic acidosis or hypoglycemia, especially when there is a rapid decline in kidney function. It is advisable to temporarily discontinue this medication and consult a doctor in the case of dehydration. Caution is also needed when used with other medications that may affect kidney function. Due to the potential increase in cardiovascular mortality, it is important to fully understand the risks and benefits of this medication in conjunction with other treatments. It should not be administered to patients with insulin-dependent diabetes, acute metabolic acidosis, severe liver or kidney dysfunction, or to pregnant or breastfeeding women. The risk of hypoglycemia is higher during the initial dosing phase, so special caution is required for patients with poor nutritional status, irregular eating patterns, excessive alcohol consumption, or weakened kidney or liver function. Gastrointestinal symptoms such as diarrhea, nausea, and vomiting may occur when taking this medication, usually temporarily at first. However, if these symptoms are severe or persistent, consultation with a physician is necessary. Allergic reactions may occur, so it is essential to inform medical personnel immediately if symptoms such as hives or breathing difficulties arise. Hematological anomalies and vitamin B12 deficiency may occur, hence regular blood tests and monitoring of vitamin B12 levels are necessary. As this medication is excreted through the kidneys, kidney function should be monitored regularly, and treatment should be discontinued or dosage adjusted in subjects with decreased kidney function. Drug interactions may occur when used in combination with other medications, thus it is important to inform medical personnel of all medications being taken, and closely monitor blood sugar changes. It is advised not to use this medication during pregnancy or breastfeeding, and to consider switching to insulin therapy instead. Extra caution is required for children and the elderly; particularly, dosage adjustment and monitoring are crucial for elderly patients due to reduced kidney function. In case of overdose, severe side effects such as hypoglycemia or lactic acidosis may occur, requiring immediate medical treatment. While taking this medication, it is vital to maintain a regular diet and exercise, and to undergo routine blood sugar and kidney function tests. Caution is advisable during driving or operating machinery due to potential decreased alertness from hypoglycemia or hyperglycemia. Store this medication out of reach of children and avoid transferring it to a different container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, hypotension or severe allergic reactions, severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice of skin or eyes, general malaise, liver abnormalities, sudden and severe headache, seizures, loss of consciousness, visual disturbances, paralysis, severe kidney issues.

Mild side effects

Nausea, vomiting, abdominal distension, loss of appetite, indigestion, constipation, abdominal pain, unpleasant metallic taste, visual impairment, erythema, itching, rash, diarrhea, abdominal swelling, palpitations, dizziness, hematological abnormalities (thrombocytopenia, leukopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis, pancytopenia), elevated liver enzymes, liver dysfunction (cholestasis, hepatitis), hepatitis, allergic vasculitis, skin photosensitivity.

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

Storage

This medication should be stored in a sealed container to prevent air entry, at a temperature between 1°C and 30°C. This helps maintain the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

White, oblong film-coated tablet

Package unit

30 tablets/bottle, 100 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.