Medication info
Diabex 500 mg Tablets (Metformin Hydrochloride)

Diabex 500 mg Tablets (Metformin Hydrochloride)

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

MFDS item code 198500321 · Notified 1985.07.03 · Insurance code 641600390

Summary

Main use
Improvement of blood sugar control and treatment of type 2 diabetes
Who takes it
Adults · Children
Adult dose
The dosing regimen should be based on individual drug efficacy and tolerance, without exceeding the recommended maximum dose per day. This medication should be initiated at a low dose to reduce gastrointestinal adverse reactions and to determine the minimum effective dose for proper blood sugar control, generally taken 2-3 times a day at a dose of 500mg with meals. Doses can be incremented by 500mg weekly, and for a total dosage of 2000mg, it is usually administered in two divided doses in the morning and evening. If exceeding 2000mg, it should be taken in three doses with meals, up to a maximum of 2550mg per day. Upon initiation or adjustment of the dose, blood glucose should be measured in a fasting state to assess the treatment response and to determine the minimum effective dose. Glycated hemoglobin levels should be measured approximately every three months. The treatment goal is to maintain fasting blood sugar and glycated hemoglobin levels within normal or near-normal ranges when used either alone or in combination with sulfonylureas or insulin, at minimum effective doses. In general, if a patient whose blood sugar is controlled by diet only temporarily loses control, sufficient effect can still be achieved with short-term use of this medication. For children and adolescents, this medication can be used for children over 10 years or adolescents in growth. The usual starting dose is 500 milligrams once daily, taken during or after a meal. Blood glucose levels should be checked after a week to adjust the dosage. Gastrointestinal side effects may improve with gradual dose increase. The maximum daily dose is 2000mg, and the corresponding dosage should be divided into 2-3 doses. For patients with renal impairment, this medication can be used with appropriate dosage adjustments in patients with stage 3a moderate renal impairment (Creatinine clearance [CrCl] 45≤~<60ml/min or glomerular filtration rate [GFR] 45≤~<60mL/min/1.73㎡) provided that they do not exhibit other symptoms that could increase the risk of lactic acidosis. The starting dose is 500mg or 850mg once daily. The maximum daily dose is 1000mg, divided into two doses. Renal function should be closely monitored every 3-6 months. If the creatinine clearance or glomerular filtration rate falls below 45ml/min or 45ml/min/1.73㎡, administration of this medication should be immediately stopped.
Child dose
Can be used for children over 10 years or adolescents in growth. The usual starting dose is 500 milligrams once a day, taken during or after a meal. Blood sugar levels should be measured after a week.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Improvement of blood sugar control and treatment of type 2 diabetes

  • Insufficient blood sugar control
View approved original text

This medication is used for the treatment of type 2 diabetes in patients who have difficulty controlling blood sugar levels with diet and exercise alone. It is especially effective for overweight diabetic patients and can be used alone or in combination with other oral hypoglycemic agents or insulin in adults. It can also be used alone or in combination with insulin for children over 10 years and adolescents in growth. Therefore, this medication helps improve blood sugar control according to various age groups and treatment conditions.

How to take

Adult dose

The dosing regimen should be based on individual drug efficacy and tolerance, without exceeding the recommended maximum dose per day. This medication should be initiated at a low dose to reduce gastrointestinal adverse reactions and to determine the minimum effective dose for proper blood sugar control, generally taken 2-3 times a day at a dose of 500mg with meals. Doses can be incremented by 500mg weekly, and for a total dosage of 2000mg, it is usually administered in two divided doses in the morning and evening. If exceeding 2000mg, it should be taken in three doses with meals, up to a maximum of 2550mg per day. Upon initiation or adjustment of the dose, blood glucose should be measured in a fasting state to assess the treatment response and to determine the minimum effective dose. Glycated hemoglobin levels should be measured approximately every three months. The treatment goal is to maintain fasting blood sugar and glycated hemoglobin levels within normal or near-normal ranges when used either alone or in combination with sulfonylureas or insulin, at minimum effective doses. In general, if a patient whose blood sugar is controlled by diet only temporarily loses control, sufficient effect can still be achieved with short-term use of this medication. For children and adolescents, this medication can be used for children over 10 years or adolescents in growth. The usual starting dose is 500 milligrams once daily, taken during or after a meal. Blood glucose levels should be checked after a week to adjust the dosage. Gastrointestinal side effects may improve with gradual dose increase. The maximum daily dose is 2000mg, and the corresponding dosage should be divided into 2-3 doses. For patients with renal impairment, this medication can be used with appropriate dosage adjustments in patients with stage 3a moderate renal impairment (Creatinine clearance [CrCl] 45≤~<60ml/min or glomerular filtration rate [GFR] 45≤~<60mL/min/1.73㎡) provided that they do not exhibit other symptoms that could increase the risk of lactic acidosis. The starting dose is 500mg or 850mg once daily. The maximum daily dose is 1000mg, divided into two doses. Renal function should be closely monitored every 3-6 months. If the creatinine clearance or glomerular filtration rate falls below 45ml/min or 45ml/min/1.73㎡, administration of this medication should be immediately stopped.

Child dose

Can be used for children over 10 years or adolescents in growth. The usual starting dose is 500 milligrams once a day, taken during or after a meal. Blood sugar levels should be measured after a week.

Precautions

This medication can cause severe lactic acidosis or hypoglycemia, so if these symptoms occur, medical attention should be sought immediately. This medication should not be administered to patients with moderate or severe renal impairment, dehydration, acute conditions such as serious infections, or heart diseases. Patients with acute or unstable heart failure, patients undergoing radiological iodine contrast tests, or patients allergic to this medication or biguanide drugs should not use this medication. This medication is not suitable for patients with type 1 diabetes or a history of lactic acidosis or diabetic ketoacidosis. Patients with severe infections or severe trauma should temporarily stop taking this medication, and it should be stopped 48 hours prior to surgery; it can be resumed only after confirming normal kidney function. Caution is also needed for patients with poor nutritional status, liver dysfunction, severe pulmonary dysfunction, and excessive alcohol intake. During the use of this medication, irregular meals, vigorous exercise, or the use of interacting medications can increase the risk of lactic acidosis or hypoglycemia. Lactic acidosis is a very rare but serious side effect; symptoms such as fatigue, muscle pain, respiratory distress, and abdominal pain should be communicated to healthcare professionals immediately. Gastrointestinal disturbances may occur when first taking this medication; however, these are mostly temporary and can be alleviated by taking it with meals. Since this medication is excreted through the kidneys, kidney function should be regularly checked, and administration should be stopped if kidney function declines. Alcohol intake can increase the risk of side effects from this medication, so excessive drinking should be avoided while taking it. Blood sugar control should be regularly monitored, and immediate appropriate actions should be taken if hypoglycemic symptoms occur. During pregnancy, this medication crosses the placenta, therefore, fetal growth status should be closely monitored, and administration can be ceased if necessary. If breastfeeding, since this medication is secreted in breast milk, the decision to continue breastfeeding should be made in consultation with a doctor. Elderly patients are at risk of renal function decline, and therefore dosage should be adjusted, and regular kidney function tests should be conducted. There may be interactions between this medication and others, so any other medications being taken must be reported to a doctor or pharmacist. In the case of overdose, the medication can be removed via hemodialysis, so it is important to inform healthcare professionals immediately if the dosage exceeds recommendations. This medication does not cause weight gain and helps with blood sugar control and prevention of diabetes complications during long-term use. Keep this medication out of reach of children, and do not transfer it to other containers as a safety measure.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis (fatigue, muscle pain, difficulty breathing, weakness, abdominal pain, decreased body temperature, low blood pressure, resistance bradyarrhythmia), severe hives, severe swelling (edema), severe allergic reactions, difficulty breathing, liver problems (jaundice), serious skin reactions, severe hypoglycemia, risk of lactic acidosis due to worsened kidney function, severe edema associated with elevated blood pressure

Mild side effects

Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal distension, loss of appetite, indigestion, constipation, abdominal pain), unpleasant or metallic taste, erythema, itching, hives, rashes, anemia, decreased white blood cells, decreased platelets, vitamin B12 deficiency, liver dysfunction, hypoglycemia

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

Storage

This medication should be stored in a tightly sealed container to avoid contact with air or moisture, and it is best kept at room temperature, away from extreme heat or cold.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 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.