Empolmin 500 mg (Metformin Hydrochloride)

Adult dosage

The dosing regimen should be determined based on individual drug effect and tolerance, and should not exceed the recommended maximum daily dose. This medication should start at a low dosage to reduce gastrointestinal adverse effects and to ascertain the minimum dose required for adequate blood sugar control, administered 500 mg with meals, 2-3 times daily. The dosage can be gradually increased weekly by 500 mg, and at 2000 mg, it is typically split into two doses, in the morning and evening. Exceeding 2000 mg requires splitting into three doses with meals, with a maximum daily dose of 2550 mg. During the initiation and dose adjustment phase, fasting blood glucose should be monitored to assess response to the treatment and determine the minimum effective dose. The blood levels of glycosylated hemoglobin should be measured approximately every three months. The treatment goal is to reduce fasting blood glucose and blood levels of glycosylated hemoglobin to normal or close to normal levels, either through monotherapy or in combination with sulfonylureas or insulin, at the minimum effective dose. Generally, if a patient’s blood sugar has been controlled with diet alone but temporarily becomes uncontrolled, sufficient effect can be achieved with a short course of this medication. In children and adolescents in growth, this medication can be used in those over 10 years. Starting dose is generally 500 mg once daily, administered with or after meals. Blood sugar levels should be checked after one week to adjust the dose. Gastrointestinal side effects can be improved with gradual dose increases. The maximum daily dose is 2000 mg and the recommended dose should be divided into 2-3 doses.

Children's dosage

This medication can be used in children over 10 years or adolescents in growth. General starting dose is 500 mg once daily, administered with or after meals. Blood sugar levels should be measured after one week to adjust the dose.

This medication may cause severe lactic acidosis or hypoglycemia, so caution is required. It should not be administered to patients with moderate to severe renal impairment or acute conditions such as dehydration, serious infections, cardiovascular collapse, acute myocardial infarction, or sepsis. It cannot be used in patients with acute and unstable heart failure, and should be discontinued before and after tests that involve intravenous administration of iodinated contrast agents. It is not administered to patients with hypersensitivity to this medication or biguanide medications, type 1 diabetes patients, acute or chronic metabolic acidosis patients, or patients in diabetic pre-coma. In patients with severe infections or severe traumatic systemic disorders, administration should be temporarily discontinued and resumed after the patient’s condition has recovered. In the case of surgery, administration should be stopped 48 hours prior to the procedure, and resumed only after normal kidney function has been confirmed. It should be used with caution in patients who are malnourished, in a state of starvation, frail, have pituitary dysfunction, or adrenal insufficiency. Avoid administration in patients with liver dysfunction, pulmonary embolism, severe pulmonary dysfunction, excessive alcohol consumption, dehydration, gastrointestinal disorders such as diarrhea and vomiting. It should not be administered to pregnant women with placental dysfunction, pre-eclampsia, or risk of delayed intrauterine growth. Since it contains lactose, do not use it in patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Use cautiously in patients with irregular meals, inadequate food intake, intense muscle activity, or taking drug interactions. Lactic acidosis is rare but can be fatal; if symptoms occur, discontinue immediately and consult a healthcare professional. Gastrointestinal symptoms may be common at the start of treatment and can be alleviated by taking with food or gradually increasing the dosage. Metallic taste, rash, anemia, vitamin B12 deficiency, abnormal liver function, hypoglycemia, and other adverse reactions may occur, requiring caution. Kidney function should be monitored regularly, especially in the elderly or those with reduced kidney function. Alcohol can affect lactate metabolism, so excessive drinking should be avoided during treatment with this medication. Blood sugar control is important during pregnancy, and the decision to administer should be made carefully based on the pregnant woman's condition. This medication is secreted into breast milk; careful judgment should be made regarding whether to continue breastfeeding or discontinue drug therapy. Dose adjustments and caution are necessary for children and the elderly, especially with kidney function monitoring being crucial in the elderly. This medication can interact with other drugs, so inform healthcare professionals about any other medications being taken. In case of overdose, blood dialysis can remove the drug, so inform healthcare, if overdose is suspected. This medication does not cause weight gain, making it advantageous for diabetic patients needing weight control.

Serious side effects

• Lactic acidosis (including fatigue, muscle pain, difficulty breathing, weakness, abdominal pain, hypothermia, low blood pressure, and bradyarrhythmia) → severe metabolic complications.
• Rash → severe skin adverse reactions.

Mild side effects

Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal distension, loss of appetite, indigestion, constipation, abdominal pain), metallic taste, anemia, leukopenia, thrombocytopenia, vitamin B12 deficiency, abnormal liver function, and rarely severe delayed hypoglycemia.

This medication can be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is also best to store it at room temperature that is not too hot or too cold.

Appearance

White round film-coated tablets

Package unit

300 tablets/bottle