Medication info

Metforin Sustained-release Tablets (Metformin Hydrochloride)

Prescription medicationTablet경구Expired
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
White, double-convex, rectangular sustained-release tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle
Approval status
Expired

MFDS item code 201908332 · Approved 2019.12.11

This product's status changed to Expired on 2024.12.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improved blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The initial dose is one 500mg metformin hydrochloride sustained-release tablet taken once daily with the evening meal. After one week, measure blood sugar levels to adjust the dosage. When increasing the dosage, increase by 500mg weekly, taking a maximum of 2000mg daily with the evening meal. If blood sugar is not controlled at 2000mg once daily, consider administering 1000mg twice daily with meals. For patients with renal impairment, the daily dosage

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Improved blood sugar control in type 2 diabetes

  • Type 2 diabetes with inadequate blood sugar control
View approved original text

This medication is used for the treatment of adult patients with type 2 diabetes who have difficulty controlling blood sugar levels with diet and exercise alone, particularly in overweight individuals. It can be used alone, but may also be combined with other oral hypoglycemic agents or insulin to enhance blood sugar control. This helps to effectively manage blood sugar levels and improve health status.

How to take

Adult dose

The initial dose is one 500mg metformin hydrochloride sustained-release tablet taken once daily with the evening meal. After one week, measure blood sugar levels to adjust the dosage. When increasing the dosage, increase by 500mg weekly, taking a maximum of 2000mg daily with the evening meal. If blood sugar is not controlled at 2000mg once daily, consider administering 1000mg twice daily with meals. For patients with renal impairment, the daily dosage

Precautions

This medication can rarely cause a serious condition called lactic acidosis. Lactic acidosis occurs when there is an excessive accumulation of lactic acid in the body, which can be life-threatening if not treated. Care should be taken when using this medication with other hypoglycemic agents, as severe hypoglycemia may occur. This medication should not be used in patients with moderate to severe renal impairment or in acute conditions such as dehydration, severe infection, or heart failure. This medication should be suspended for a period before and after examinations using iodinated contrast agents, and resuming treatment should occur only after confirming normal kidney function. Patients with hypersensitivity to this medication, type 1 diabetes, or diabetic ketoacidosis should not be treated with this medication. Patients in states of tissue hypoxia such as before or after surgery, severe malnutrition, liver dysfunction, or acute myocardial infarction should also avoid using this medication. Caution should be exercised if there are irregular meals, vigorous exercise, or interactions with other medications. While taking this medication, side effects such as vitamin B12 deficiency, gastrointestinal disturbances (nausea, vomiting, diarrhea, etc.), taste alteration, and skin rash may occur. Notably, gastrointestinal disturbances are common during early treatment and can be alleviated by gradually increasing the dose or taking the medication with meals. Kidney function should be regularly assessed, and if significant renal impairment occurs, discontinuation of the medication is needed. Alcohol can increase the risk of side effects from this medication, so excessive drinking should be avoided. During pregnancy, this medication may affect the fetus; hence, pregnant or nursing women should consult with a physician before using it. It is not recommended for children, as safety and efficacy have not been established. Elderly patients should have dosage adjustments made and undergo regular monitoring of kidney function due to common renal impairment. In cases of overdose, hypoglycemia is rare but there is a risk of lactic acidosis; immediate medical attention should be sought, and if necessary, treatments like dialysis should be administered. This medication may interact with other drugs, so be sure to inform your doctor or pharmacist about any other medications you are taking. The tablets should not be crushed or chewed; they must be swallowed whole, and it is normal for the tablet coating to appear in the stool. Regular blood glucose monitoring and kidney function testing during the course of treatment are essential to confirm the efficacy and check for any side effects.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis (including fatal cases due to lactic acidosis), hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory symptoms accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache

Mild side effects

  • Vitamin B12 deficiency
  • taste alteration
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • erythema
  • itching
  • hives
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  • rash

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

Storage

Store this medication in a tightly closed container, protected from air and moisture. To maintain the medication's effectiveness, it is best kept at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, double-convex, rectangular sustained-release tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 300 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.