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AVANDAMET
Overview
What is AVANDAMET?
AVANDAMET contains 2 oral antidiabetic drugs: rosiglitazone maleate and metformin hydrochloride.
Rosiglitazone maleate is an oral antidiabetic agent, which acts primarily by increasing insulin sensitivity. Rosiglitazone improves glycemic control while reducing circulating insulin levels. Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors. Chemically, rosiglitazone maleate is (±)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, ()-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The molecular formula is CHNOS•CHO. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122° to 123°C. The pK values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range. The structural formula of rosiglitazone maleate is:
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antidiabetic agents. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of CHN•HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula of metformin hydrochloride is:
AVANDAMET is available for oral administration as film-coated tablets containing rosiglitazone maleate and metformin hydrochloride equivalent to: 2 mg rosiglitazone with 500 mg metformin hydrochloride (2 mg/500 mg), 4 mg rosiglitazone with 500 mg metformin hydrochloride (4 mg/500 mg), 2 mg rosiglitazone with 1,000 mg metformin hydrochloride (2 mg/1,000 mg), and 4 mg rosiglitazone with 1,000 mg metformin hydrochloride (4 mg/1,000 mg). Inactive ingredients are: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone 29-32, sodium starch glycolate, titanium dioxide, and 1 or more of the following: Red and yellow iron oxides.
What does AVANDAMET look like?
What are the available doses of AVANDAMET?
Oval, film-coated tablets containing rosiglitazone/metformin hydrochloride: 2 mg/500 mg, 4 mg/500 mg, 2 mg/1,000 mg, and 4 mg/1,000 mg (3)
What should I talk to my health care provider before I take AVANDAMET?
How should I use AVANDAMET?
After consultation with a healthcare professional who has considered and advised the patient of the risks and benefits of rosiglitazone, AVANDAMET is indicated as an adjunct to diet and exercise to improve glycemic control when treatment with both rosiglitazone and metformin is appropriate in adults with type 2 diabetes mellitus who either are:
Prior to prescribing AVANDAMET, refer to for appropriate patient selection.
What interacts with AVANDAMET?
Sorry No Records found
What are the warnings of AVANDAMET?
Excessive administration of potassium free solutions may result in significant hypokalemia.
Rosiglitazone maleate:
Metformin hydrochloride:
What are the precautions of AVANDAMET?
Sorry No Records found
What are the side effects of AVANDAMET?
Sorry No records found
What should I look out for while using AVANDAMET?
Initiation in patients with established NYHA Class III or IV heart failure. (4)
Use in significant renal disease or renal dysfunction. (4)
Use in acute or chronic metabolic acidosis. (4)
Use in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. (4, 5.1)
What might happen if I take too much AVANDAMET?
Rosiglitazone:
[see Warnings and Precautions (5.1)]
How should I store and handle AVANDAMET?
Shake well before using. Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a well-closed container as defined in the USP.Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:2 mg/500 mg – pale pink, tablet, debossed with gsk on one side and 2/500 on the other.4 mg/500 mg – orange, tablet, debossed with gsk on one side and 4/500 on the other.2 mg/1,000 mg – yellow, tablet, debossed with gsk on one side and 2/1000 on the other.4 mg/1,000 mg – pink, tablet, debossed with gsk on one side and 4/1000 on the other.Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:2 mg/500 mg – pale pink, tablet, debossed with gsk on one side and 2/500 on the other.4 mg/500 mg – orange, tablet, debossed with gsk on one side and 4/500 on the other.2 mg/1,000 mg – yellow, tablet, debossed with gsk on one side and 2/1000 on the other.4 mg/1,000 mg – pink, tablet, debossed with gsk on one side and 4/1000 on the other.Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:2 mg/500 mg – pale pink, tablet, debossed with gsk on one side and 2/500 on the other.4 mg/500 mg – orange, tablet, debossed with gsk on one side and 4/500 on the other.2 mg/1,000 mg – yellow, tablet, debossed with gsk on one side and 2/1000 on the other.4 mg/1,000 mg – pink, tablet, debossed with gsk on one side and 4/1000 on the other.Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:2 mg/500 mg – pale pink, tablet, debossed with gsk on one side and 2/500 on the other.4 mg/500 mg – orange, tablet, debossed with gsk on one side and 4/500 on the other.2 mg/1,000 mg – yellow, tablet, debossed with gsk on one side and 2/1000 on the other.4 mg/1,000 mg – pink, tablet, debossed with gsk on one side and 4/1000 on the other.Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:2 mg/500 mg – pale pink, tablet, debossed with gsk on one side and 2/500 on the other.4 mg/500 mg – orange, tablet, debossed with gsk on one side and 4/500 on the other.2 mg/1,000 mg – yellow, tablet, debossed with gsk on one side and 2/1000 on the other.4 mg/1,000 mg – pink, tablet, debossed with gsk on one side and 4/1000 on the other.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
AVANDAMET:
Rosiglitazone:
Insulin resistance is a common feature characterizing the pathogenesis of type 2 diabetes. The antidiabetic activity of rosiglitazone has been demonstrated in animal models of type 2 diabetes in which hyperglycemia and/or impaired glucose tolerance is a consequence of insulin resistance in target tissues. Rosiglitazone reduces blood glucose concentrations and reduces hyperinsulinemia in the ob/ob obese mouse, db/db diabetic mouse, and fa/fa fatty Zucker rat.
In animal models, the antidiabetic activity of rosiglitazone was shown to be mediated by increased sensitivity to insulin's action in the liver, muscle, and adipose tissue. Pharmacologic studies in animal models indicate that rosiglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. The expression of the insulin-regulated glucose transporter GLUT-4 was increased in adipose tissue. Rosiglitazone did not induce hypoglycemia in animal models of type 2 diabetes and/or impaired glucose tolerance.
Metformin:
[see Warnings and Precautions (5.11)]
Non-Clinical Toxicology
Initiation in patients with established NYHA Class III or IV heart failure. (4)Use in significant renal disease or renal dysfunction. (4)
Use in acute or chronic metabolic acidosis. (4)
Use in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. (4, 5.1)
Metformin:
Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems. Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin.
Probenecid:
Incidence and Management:
The reported incidence of lactic acidosis in patients receiving metformin is very low (approximately 0.03 cases/1,000 patient years of exposure, with approximately 0.015 fatal cases/1,000 patient years of exposure). 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 AVANDAMET and by use of the minimum effective dose of AVANDAMET. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Treatment with AVANDAMET 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, AVANDAMET 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, AVANDAMET 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 AVANDAMET, since alcohol potentiates the effects of metformin on lactate metabolism. In addition, AVANDAMET should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure.
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. AVANDAMET 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 AVANDAMET, 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 AVANDAMET 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.
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 AVANDAMET, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin 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.
Factors That May Predispose Patients to Lactic Acidosis:
Assessment of Renal Function:
[See Dosage and Administration (2.4) and Use in Specific Populations (8.5).]
Before initiation of therapy with AVANDAMET and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal dysfunction is anticipated, renal function should be assessed more frequently and AVANDAMET discontinued if evidence of renal impairment is present.
Medications That Affect Renal Function:
[see Drug Interactions (7.2) and Clinical Pharmacology (12.4)]
Hypoxic States:
Radiologic Studies With Intravascular Iodinated Contrast Materials:
[see Contraindications (4)]
Surgical Procedures:
Alcohol Intake:
Change in Clinical Status of Patients With Previously Controlled Diabetes:
[See also Warnings and Precautions (5.6).]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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