Metcon – 500 SR (metformin hydrochloride extended-release)

METCON 500-SR

(Metformin Hydrochloride Extended-Release Tablets USP 500mg)

 

COMPOSITION

Each uncoated extended release tablet contains

Metformin Hydrochloride BP………………500mg

Excipients……q.s

 

INDICATIONS: Metformin is used for treating type 2 diabetics in adults and children. It is used alone or in combination with other diabetic medications. Metformin has also been used to prevent the development of diabetes in people at risk for diabetes, for the treatment of polycystic ovaries and weight gain due to medications used for the treatment of psychosis.

 

MECHANISM OF ACTION: Metformin belongs to a group of medicines called biguanides. It lowers blood glucose by helping the body make better use of insulin. It lowers both basal and postprandial plasma glucose. It does not stimulate insulin release and therefore does not produce hypoglycemia.

 

DOSAGE AND ADMINISTRATION: The dose should be swallowed whole with adequate fluid.

Adults: the starting dose of METCON 500-SR is 500mg-1000mg daily with the evening meal. The dose can be increased by 500mg weekly up to a maximum of 2000mg to be taken once or in two divided doses. METCON 500-SR should be taken with meals.

For pediatric patients 10-16 years of age, the starting dose is 500mg twice a day. The dose can be increased by 500mg weekly up to a maximum dose of 2000mg.

Metformin has not been studied in children.

 

CONTRAINDICATIONS:

Hypersensitivity to metformin hydrochloride or to any of the excipients

Diabetic ketoacidosis, diabetic pre-coma

Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock & intravenous administration of iodinated contrast agents.

Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock.

Hepatics insufficiency, acute alcohol intoxication, alcoholism

Lactation.

PREGNANCY: There is insufficient data for the use of metformin in pregnant women.

NURSING MOTHERS: Metformin is excreted into breast milk and should not be used by nursing mothers.

SIDE EFFECTS: The common side effects with metformin are nausea, vomiting, gas, bloating, diarrhea and loss of appetite. These side effects are related to the dose of the medication and may decrease if the dose is reduced.

A serious but rare side effect of metformin is lactic acidosis which occurs in one out of every 30,000 patients. The symptoms include weakness, troubled breathing, abnormal heartbeats, unusual muscle pain, stomach discomfort, light-headedness and cold. Patients at risk of lactic acidosis include those with reduced function of the kidney or liver, congestive heart failure, severe acute illnesses and dehydration.

 

DRUG INTERACTIONS: inadvisable combinations

Alcohol: increased risk of lactic acidosis in acute alcohol intoxication particularly in cases of fasting or malnutrition; hepatic insufficiency.

Intravenous iodinated contrast agents: may lead to metformin accumulation and risk of lactic acidosis.

Associations requiring precaution for use:

Glucocorticoids, beta-2 agonist and diuretics

ACE-inhibitors may decrease the blood glucose levels which may necessitate dosage adjustments.

 

OVERDOSAGE: hypoglycemia has not been seen with metformin doses of up to 85g, although lactic acidosis has occurred in such circumstances. High overdose or concomitant risk with metformin may lead to lactic acidosis.

 

STORAGE: Store in a cool, dry place and protect from light. Keep out of children.

PRESENTATION: Blister of 14 tablets. 6 blisters per pack.