Metcon-G-5 (metformin hydrochloride & glibenclamide)

METCON-G

(Metformin Hydrochloride and GlibenclamideTablets)

 

COMPOSITION

Each film coated tablet contains

Metformin Hydrochloride BP………………500mg

Glibenclamide BP …………………………. 2.5mg

Excipients……q.s

Colour: Erythrosine

 

INDICATIONS:

Type 2 diabetes mellitus

Type 2 diabetes mellitus not adequately controlled with either metformin or sulfonylurea monotherapy.

 

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. Glibenclamide belongs to the group of medicines called sulfonylureas. It lowers blood glucose by increasing the amount of insulin produced by the human pancreas.

 

DOSAGE AND ADMINISTRATION: The dose varies from person to person.

People who do not respond to either metformin or sulfonylurea medicine alone:

The usual starting dose is one Metformin Hydrochloride and Glibenclamide Tablets 500mg/2.5mg tablet once a day

Replacing combined use of metformin and a sulfonylurea or Glibenclamide.

The usual starting dose is one to two tablets of Metformin Hydrochloride and Glibenclamide Tablets 500mg/2.5mg daily.

Elderly people: the dose depends on the renal function. The usual starting dose for elderly patients may be one Metformin Hydrochloride and Glibenclamide tablets 250mg/1.25mg tablet daily.

Smaller doses may be prescribed in cases of kidney problems or generally poor health.

Increase the dose slowly over one or two weeks, depending on your blood glucose levels and other tests. The usual maximum recommended dose is one Metformin Hydrochloride and Glibenclamide Tablets 500mg/5mg tablet three times a day.

 

CONTRAINDICATIONS:

Hypersensitivity to metformin hydrochloride or glibenclamide 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:

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.