Metformin hydrochloride

Visa No.: VD-23851-15

Product: Metformine EG 1000mg

API: Metformin hydrochloride

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 277/QĐ-QLD_23/05/2022_175.1

INDICATIONS

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone do not achieve adequate glycemic control.

• In adults, metformin 1000 mg may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
• In children from 10 years of age and adolescents, metformin 1000 mg may be used as monotherapy or in combination with insulin.

A reduction in diabetic complications has been observed in overweight adult patients with type 2 diabetes mellitus treated with metformin as first-line therapy after failure of dietary management.
 

DOSAGE AND ADMINISTRATION

Adults with normal renal function (estimated glomerular filtration rate [eGFR] > 90 mL/min/1.73 m²) 
Monotherapy and combination with other oral antidiabetic agents: The usual starting dose is 500 mg or 850 mg metformin hydrochloride, administered 2 or 3 times daily during or after meals. After 10–15 days, the dose should be adjusted based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 3 g per day, pided into 3 doses. When switching from another oral antidiabetic agent, the previous drug should be discontinued and metformin initiated at the dose described above.

Combination with insulin:
Metformin and insulin may be used in combination to achieve better glycemic control. Metformin hydrochloride 500 mg or 850 mg is administered at the usual starting dose of 2 or 3 times daily, while the insulin dose is adjusted based on blood glucose measurements.

Elderly
Due to the potential for reduced renal function in elderly patients, the dose of metformin should be adjusted according to renal function. Renal function should be monitored regularly (see Warnings and Precautions).

Renal impairment
Renal function should be assessed before initiation of metformin therapy and periodically thereafter. Dose reduction may be considered according to the degree of renal impairment in patients with an eGFR of 60–89 mL/min/1.73 m²
Metformin may be used in patients with renal impairment and an eGFR of 30–59 mL/min/1.73 m² only in the absence of other conditions that may increase the risk of lactic acidosis, and with the following dose adjustment: the initial dose is 500 mg metformin hydrochloride once daily. The maximum daily dose is 1000 mg.
Metformin is contraindicated in patients with an eGFR below 30 mL/min/1.73 m².

Children and adolescents
Monotherapy and combination with insulin:

• Metformin may be used in children from 10 years of age and in adolescents.
• The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, administered during or after meals.

After 10–15 days, the dose should be adjusted based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g/day, pided into 2 or 3 doses.

Discontinuation of metformin for imaging procedures with iodinated contrast media
In patients with an eGFR between 30–60 mL/min/1.73 m², in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will receive iodinated contrast media via the intra-arterial route, metformin should be discontinued prior to or at the time of the imaging procedure. Renal function (eGFR) should be reassessed 48 hours after the procedure, and metformin may be restarted if renal function is stable.

Method of administration:
Swallow the tablets whole, without chewing, during or at the end of a meal. This helps reduce gastrointestinal discomfort. For example, when taking two tablets daily, one tablet should be taken at breakfast and one at the evening meal.
Duration of treatment:
Metformin should be taken continuously on a daily basis. Patients who discontinue treatment should contact their physician.
Missed dose:
If a dose is missed, the patient should take the next dose at the usual scheduled time. The dose should not be doubled to make up for a missed dose.
 

CONTRAINDICATIONS

• Hypersensitivity to metformin or to any of the excipients.
• Any type of acute metabolic acidosis (such as lactic acidosis or diabetic ketoacidosis).
• Diabetic pre-coma.
• Severe renal impairment, with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
• Acute conditions with the potential to alter renal function, such as dehydration, severe infection, or shock.
• Conditions associated with tissue hypoxia (particularly acute conditions or acute worsening of chronic disease), such as decompensated heart failure, respiratory failure, recent myocardial infarction, or shock.
• Hepatic impairment, acute alcohol intoxication, or alcoholism.
• Pregnancy (insulin therapy should be used; metformin must not be used).
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children