Medication info
Innoen Metformin Extended-Release Tablets (Metformin Hydrochloride)

Innoen Metformin Extended-Release Tablets (Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
White rectangular tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201401518 · Approved 2014.03.31

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The initial dose is 500 mg of metformin hydrochloride extended-release tablets taken once daily with the evening meal. After one week, measure blood sugar levels to adjust the dosage, and any gastrointestinal adverse effects may be improved with gradual dose increases. The maximum dose is 2000 mg per day, and when increasing the dose, it should be raised by 500 mg weekly and taken with the evening meal. Even if controlled, up to 2000 mg once daily may still be insufficient for blood sugar control. If blood sugar control is not achieved with 2000 mg per day, 1000 mg twice daily may be considered, ensuring both doses are taken with meals. For patients already on metformin tablets, the initial dose of this formulation should be the same as their daily dose of immediate-release metformin. Conversion from more than 2000 mg of immediate-release metformin to this formulation is not recommended. To evaluate the treatment response and determine the minimum effective dose, blood sugar levels should be measured when initiating treatment and titrating the dose. Hemoglobin A1c levels should be monitored approximately every 3 months. The goal of treatment with this medication is to reduce fasting blood sugar and hemoglobin A1c levels to normal or near-normal levels when used alone or in combination with sulfonylureas or insulin, at the minimum effective dose. For patients with renal impairment, This medication may be used, with dosage adjustments as follows, for patients with stage 3a moderate renal impairment (creatinine clearance [CrCl] 45 ≤ <60 ml/min or glomerular filtration rate [GFR] 45 ≤ <60 mL/min/1.73 m2), if there are no other signs that could indicate an increased risk of lactic acidosis. - The starting dose is either 500 mg or 750 mg once daily. The maximum daily dose is 1000 mg. Kidney function should be closely monitored every 3 to 6 months. If the creatinine clearance or glomerular filtration rate falls below 45 ml/min or 45 ml/min/1.73 m2, this medication should be immediately discontinued.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This medication is used for the treatment of adult patients with type 2 diabetes whose blood sugar control is insufficient with diet and exercise alone. It is especially effective in overweight diabetic patients and can be used alone or in combination with other oral hypoglycemic agents or insulin. This helps improve blood sugar levels and assists in diabetes management.

How to take

Adult dose

The initial dose is 500 mg of metformin hydrochloride extended-release tablets taken once daily with the evening meal. After one week, measure blood sugar levels to adjust the dosage, and any gastrointestinal adverse effects may be improved with gradual dose increases. The maximum dose is 2000 mg per day, and when increasing the dose, it should be raised by 500 mg weekly and taken with the evening meal. Even if controlled, up to 2000 mg once daily may still be insufficient for blood sugar control. If blood sugar control is not achieved with 2000 mg per day, 1000 mg twice daily may be considered, ensuring both doses are taken with meals. For patients already on metformin tablets, the initial dose of this formulation should be the same as their daily dose of immediate-release metformin. Conversion from more than 2000 mg of immediate-release metformin to this formulation is not recommended. To evaluate the treatment response and determine the minimum effective dose, blood sugar levels should be measured when initiating treatment and titrating the dose. Hemoglobin A1c levels should be monitored approximately every 3 months. The goal of treatment with this medication is to reduce fasting blood sugar and hemoglobin A1c levels to normal or near-normal levels when used alone or in combination with sulfonylureas or insulin, at the minimum effective dose. For patients with renal impairment, This medication may be used, with dosage adjustments as follows, for patients with stage 3a moderate renal impairment (creatinine clearance [CrCl] 45 ≤ <60 ml/min or glomerular filtration rate [GFR] 45 ≤ <60 mL/min/1.73 m2), if there are no other signs that could indicate an increased risk of lactic acidosis. - The starting dose is either 500 mg or 750 mg once daily. The maximum daily dose is 1000 mg. Kidney function should be closely monitored every 3 to 6 months. If the creatinine clearance or glomerular filtration rate falls below 45 ml/min or 45 ml/min/1.73 m2, this medication should be immediately discontinued.

Precautions

This medication can rarely cause a condition called lactic acidosis, which is a dangerous complication that can be life-threatening. Care should be taken when used with other diabetes medications, as hypoglycemia may occur. This medication should not be used in patients with moderate to severe kidney impairment, dehydration, serious infections, or heart problems. Administration should be temporarily suspended before and after tests using iodinated contrast media, resuming only after kidney function is confirmed to be normal. Patients with allergies to this medication or similar drugs should not take it. It is not suitable for patients with type 1 diabetes or diabetic ketoacidosis. This medication should also be temporarily discontinued in cases of severe infection, major injury, or before and after surgery, and can be resumed after the patient's condition has recovered. Caution is required in patients with poor nutritional status, decreased liver function, or excessive alcohol consumption. Pregnant women with placental function issues or at risk for preeclampsia are advised against using this medication. Patients with irregular or insufficient food intake, those engaging in rigorous exercise, or those at risk of drug interactions should be treated cautiously. While taking this medication, kidney function should be regularly monitored to prevent the buildup of the drug in the body, leading to dangerous conditions. Gastrointestinal symptoms may often occur during initial treatment but usually improve over time. In case of severe diarrhea or vomiting, the risk of dehydration may necessitate temporary discontinuation of the medication. While this medication rarely causes hypoglycemia on its own, patients should be cautious about hypoglycemia symptoms when used with other hypoglycemic agents. Alcohol consumption can increase risks when taking this medication, so excessive drinking should be avoided. If blood sugar control is needed during pregnancy, this medication may be used at the discretion of a physician, but careful monitoring of fetal growth is necessary. Breastfeeding mothers must consider whether to continue nursing or to discontinue medication, as this drug is excreted in breast milk. It is not recommended for children as safety and efficacy have not been established. Elderly patients are at higher risk of decreased kidney function, requiring careful dose adjustments and regular kidney function monitoring. In the case of overdose, inform medical personnel immediately due to the risk of lactic acidosis, and treatment may include dialysis if necessary. This medication should be swallowed whole without chewing or crushing, and it is normal for the tablet coating to appear in the stool. Regular blood sugar and kidney function tests should be performed to confirm therapeutic effectiveness and safety during treatment.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis (may be fatal, includes symptoms such as vomiting, shortness of breath, muscle pain, weakness, abdominal pain, low body temperature, low blood pressure, bradyarrhythmias, etc.)
  • Severe allergic reactions (treatment should be discontinued if severe symptoms such as hives occur)
  • Risk of acute kidney failure (kidney function re-evaluation required when using iodinated contrast agents)
  • Liver dysfunction (contraindicated in patients with liver function impairment)
  • Severe edema or urinary problems (discontinue treatment if kidney function significantly declines)
  • Respiratory issues (hypoxemia,

Mild side effects

  • Vitamin B12 deficiency, taste disturbance, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, erythema, itching, hives, rash
  • Hypoglycemia (may occur under certain conditions)

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain room temperature between 1-degree Celsius and 30-degree Celsius for optimal efficacy.

Appearance and packaging

Appearance

White rectangular tablet

Package unit

30 tablets/bottle, 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.