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Basic Drug Info
Drug Name:Metformin Hydrochloride
Manufacturer:TORRENT PHARMACEUTICALS LTD.
Other Info:

8008587torrentManufactured by:TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist.

Mehsana, India.For:TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009.



Clinical Trials:


Indications and Usage

Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes.

Metformin is indicated in patients 10 years of age and older.

Metformin may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).
Diabetes Mellitus, Non-Insulin-Dependent -- subclass of diabetes mellitus that is not insulin responsive or dependent; characterized initially by insulin resistance and hyperinsulinemia and eventually by glucose intolerance, hyperglycemia, and overt diabetes; type II diabetes mellitus is no longer considered a disease exclusively found in adults; patients seldom develop ketosis but often exhibit obesity.

Contraindications

Metformin hydrochloride tablets are contraindicated in patients with:Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ? 1.5 mg/dL [males], ? 1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).

Known hypersensitivity to metformin hydrochloride.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Diabetic ketoacidosis should be treated with insulin.Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

(See also PRECAUTIONS.)
Kidney Diseases -- Pathological processes of the KIDNEY or its component tissues.

Shock -- A pathological condition that can suddenly affect the hemodynamic equilibrium, usually manifested by failure to perfuse or oxygenate vital organs.

Acute myocardial infarction --

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Metabolic acidosis -- (met-ah-BOL-ik as-id-O-sis) A condition in which the blood is too acidic. It may be caused by severe illness or sepsis (bacteria in the bloodstream).

Diabetic Ketoacidosis -- A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

comatose -- A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION.

Warnings

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases.

Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia.

Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.

When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found.The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years).

In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis.

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications.

Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis.

The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age.

The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin.

In particular, treatment of the elderly should be accompanied by careful monitoring of renal function.

Metformin treatment should not be initiated in patients ? 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis.

In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration or sepsis.

Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.

Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism.

In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress.

There may be associated hypothermia, hypotension and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS).

Metformin hydrochloride tablets should be withdrawn until the situation is clarified.

Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels, and even blood metformin levels may be useful.

Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related.

Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking metformin do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity or technical problems in sample handling.

(See also PRECAUTIONS.)Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).Lactic acidosis is a medical emergency that must be treated in a hospital setting.

In a patient with lactic acidosis who is taking metformin, the drug should be discontinued immediately and general supportive measures promptly instituted.

Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin.

Such management often results in prompt reversal of symptoms and recovery.

(See also CONTRAINDICATIONS and PRECAUTIONS.)
Branded Drugs
The following US Branded drugs contain Metformin Hydrochloride


GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- CARACO PHARMACEUTICAL LABORATORIES LTD

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- COREPHARMA LLC

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- MYLAN PHARMACEUTICALS INC

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- TEVA PHARMACEUTICALS USA

METAGLIP -- BRISTOL MYERS SQUIBB CO

GLUCOVANCE -- BRISTOL MYERS SQUIBB

GLYBURIDE AND METFORMIN HYDROCHLORIDE -- ACTAVIS ELIZABETH LLC

GLYBURIDE AND METFORMIN HYDROCHLORIDE -- AUROBINDO PHARMA LTD

GLYBURIDE AND METFORMIN HYDROCHLORIDE -- COREPHARMA LLC

GLYBURIDE AND METFORMIN HYDROCHLORIDE -- IVAX PHARMACEUTICALS INC

GLYBURIDE AND METFORMIN HYDROCHLORIDE -- TEVA PHARMACEUTICALS USA INC

RIOMET -- RANBAXY PHARMACEUTICALS INC

FORTAMET -- ANDRX LABS LLC

GLUCOPHAGE XR -- BRISTOL MYERS SQUIBB CO

GLUMETZA -- DEPOMED INC

GLUCOPHAGE -- BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

ACTOPLUS MET -- TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC

PRANDIMET -- NOVO NORDISK INC

AVANDAMET -- SB PHARMCO PUERTO RICO INC

JANUMET -- MERCK AND CO INC


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