Medication info

Ospomine Tablets (Metformin Hydrochloride)

Prescription medicationTabletExpired
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)오스코리아제약
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201501723 · Approved 2015.03.31

This product's status changed to Expired on 2025.03.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of type 2 diabetes (blood sugar control)
Who uses it
Adults · Children
Adult dosage
The administration dosage should be determined based on individual drug efficacy and tolerance, and should not exceed the recommended maximum daily dosage. This medication should initially be administered in low doses to reduce gastrointestinal adverse reactions and to identify the minimum effective dose required for appropriate blood sugar control; it should be taken in divided doses of 500 mg 2 to 3 times daily with meals. The dosage can be gradually increased weekly by 500 mg, with a typical maximum dose of 2000 mg usually taken in the morning and evening. If the dose exceeds 2000 mg, it should be divided into three doses taken with meals, up to a maximum dose of 2550 mg per day. During initiation of treatment and dosage adjustment, fasting blood sugar levels should be measured to assess treatment response and confirm the minimum effective dose. The concentration of glycated hemoglobin in the blood should be measured every three months. The treatment goal for this medication is to reduce fasting blood glucose and glycated hemoglobin levels to normal or near-normal levels when administered as monotherapy or in combination with sulfonylureas or insulin at the minimum effective dose. Generally, this medication can provide sufficient effect when administered for a short period if patients whose blood sugar levels are controlled only with dietary therapy temporarily experience inadequate blood sugar control. For children and adolescents, this medication can be used in patients aged 10 years and older. The general initial dosage is 500 mg once daily, taken during or after meals. Blood sugar levels should be measured after one week to adjust the dosage. Gastrointestinal side effects may improve with gradual dosage increase. The maximum daily dosage is 2000 mg and should be divided into 2 to 3 doses.
Children's dosage
Can be used in children aged 10 years and older or adolescents during growth phases. The general initial dosage is 500 mg once daily, taken during or after meals. After one week, blood sugar levels should be checked to adjust the dosage.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Improvement of type 2 diabetes (blood sugar control)

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

This medication is used for the treatment of patients with type 2 diabetes for whom dietary management and exercise alone are not sufficient for blood sugar control. It is particularly effective for adult patients who are overweight. This medication can be used alone or in conjunction with other oral hypoglycemic agents or insulin. It can also be used in children aged 10 years and older and adolescents during growth phases either as monotherapy or in combination with insulin. Therefore, it helps improve blood sugar control in patients with type 2 diabetes across various age groups.

Dosage and Administration

Adult dosage

The administration dosage should be determined based on individual drug efficacy and tolerance, and should not exceed the recommended maximum daily dosage. This medication should initially be administered in low doses to reduce gastrointestinal adverse reactions and to identify the minimum effective dose required for appropriate blood sugar control; it should be taken in divided doses of 500 mg 2 to 3 times daily with meals. The dosage can be gradually increased weekly by 500 mg, with a typical maximum dose of 2000 mg usually taken in the morning and evening. If the dose exceeds 2000 mg, it should be divided into three doses taken with meals, up to a maximum dose of 2550 mg per day. During initiation of treatment and dosage adjustment, fasting blood sugar levels should be measured to assess treatment response and confirm the minimum effective dose. The concentration of glycated hemoglobin in the blood should be measured every three months. The treatment goal for this medication is to reduce fasting blood glucose and glycated hemoglobin levels to normal or near-normal levels when administered as monotherapy or in combination with sulfonylureas or insulin at the minimum effective dose. Generally, this medication can provide sufficient effect when administered for a short period if patients whose blood sugar levels are controlled only with dietary therapy temporarily experience inadequate blood sugar control. For children and adolescents, this medication can be used in patients aged 10 years and older. The general initial dosage is 500 mg once daily, taken during or after meals. Blood sugar levels should be measured after one week to adjust the dosage. Gastrointestinal side effects may improve with gradual dosage increase. The maximum daily dosage is 2000 mg and should be divided into 2 to 3 doses.

Children's dosage

Can be used in children aged 10 years and older or adolescents during growth phases. The general initial dosage is 500 mg once daily, taken during or after meals. After one week, blood sugar levels should be checked to adjust the dosage.

Precautions

This medication can cause severe lactic acidosis or hypoglycemia and should be used with caution. It should not be administered to patients with moderate to severe impairment of renal function or those in acute conditions such as dehydration, severe infections, and cardiovascular collapse. It should also be avoided in patients with acute and unstable heart failure or those undergoing tests with radiopaque iodine contrast agents. Patients allergic to this medication or biguanide medications, as well as those with type 1 diabetes or metabolic acidosis, should not use this medication. For patients with serious infections, trauma, or undergoing surgery, the administration of this medication should be temporarily suspended and resumed only after the patient's condition improves. It should be administered with caution in malnourished states, starvation, debility, liver impairment, pulmonary impairment, or excessive alcohol consumption. This medication can cause a serious side effect known as lactic acidosis, which can be fatal; therefore, symptoms must be reported to a doctor immediately. Common gastrointestinal side effects include diarrhea, nausea, and vomiting; these symptoms generally improve naturally over time. While this medication lowers blood sugar, the risk of hypoglycemia may increase when taken with other hypoglycemic agents or alcohol, so caution is required. Regular kidney function tests should be conducted, and if kidney function declines, the medication should be discontinued or the dosage adjusted. Alcohol intake can affect lactate metabolism and increase the risk of lactic acidosis, so excessive drinking should be avoided while on this medication. No adverse effects on the fetus have been reported during pregnancy, but if there are risks of placental insufficiency or preeclampsia, administration should be avoided and fetal development should be closely monitored. During breastfeeding, as this medication may be secreted in breast milk, careful consideration of breastfeeding and medication treatment should be undertaken. Elderly patients often have declining kidney function, so dosing adjustments and regular kidney function monitoring are essential. There are several medications that interact with this drug, so consultation with a doctor or pharmacist is advisable if other medications are being taken. In case of overdose, the medication can be removed through hemodialysis, so care must be taken not to exceed the recommended dosage. This medication does not cause weight gain, which may be beneficial for diabetic patients needing weight management. When administered to children or adolescents, growth and development should be monitored closely.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis (severe lactic acidosis), severe allergic reactions (such as rashes), liver abnormalities (liver dysfunction), hypoglycemia (severe delayed hypoglycemia), severe edema and urination abnormalities due to worsening kidney function

Mild side effects

Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal bloating, loss of appetite, dyspepsia, constipation, abdominal pain), unpleasant or metallic taste, rash, anemia, leukopenia, thrombocytopenia, vitamin B12 deficiency, liver dysfunction, hypoglycemia (rarely severe delayed)

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. Proper storage will ensure the safe maintenance of the medication's efficacy.

Appearance and packaging

Appearance

White round film-coated tablets

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.