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Basic Drug Info
Drug Name:FORTAMET
Manufacturer:Sciele Pharma, Inc.
Other Info:

FORTAMET® is not recommended for use in pregnancy, and is not recommended in patients below the age of 17 years.The initial and maintenance dosing of FORTAMET® should be conservative in patients with advanced age, due to the potential for decreased renal function in this population.

Any dosage adjustment should be based on a careful assessment of renal function.

Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of FORTAMET®.Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly (see WARNINGS).



Clinical Trials:


Indications and Usage
FORTAMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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

FORTAMET® is 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.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Diabetic ketoacidosis should be treated with insulin.FORTAMET® 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.


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