A: Avandia has been
associated with rare but
serious liver injury. Call
your healthcare provider
right away if you develop
nausea, vomiting, stomach
pain, a feeling of tiredness
or having no energy, loss
of appetite, dark urine, or
jaundice (yellow coloring of
eyes and skin). These may
be symptoms of liver
problems.
h.
associated with rare but
serious liver injury. Call
your healthcare provider
right away if you develop
nausea, vomiting, stomach
pain, a feeling of tiredness
or having no energy, loss
of appetite, dark urine, or
jaundice (yellow coloring of
eyes and skin). These may
be symptoms of liver
problems.
h.
AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity.
AVANDIA is used in the management of type 2 diabetes mellitus also known as non-
insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes.
AVANDIA improves glycemic control while reducing circulating insulin levels.
Pharmacological studies in animal models indicate that rosiglitazone improves sensitivity to
insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis.
Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the
biguanides, or the alpha-glucosidase inhibitors.
Rosiglitazone, a member of the thiazolidinedione class of antidiabetic agents, improves
glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and
potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ).
In humans, PPAR receptors are found in key target tissues for insulin action such as
adipose tissue, skeletal muscle, and liver.
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, rosiglitazone’s antidiabetic activity was shown to be mediated by
increased sensitivity to insulin’s action in the liver, muscle, and adipose tissues.
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.
The elimination half-life is 3 to 4 hours and is independent of dose.
The absolute bioavailability of rosiglitazone is 99%.
Peak plasma concentrations are observed about 1 hour after dosing.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC),
but there was an approximately 28% decrease in Cmax and a delay in Tmax (1.75 hours).
These changes are not likely to be clinically significant; therefore, AVANDIA may be
administered with or without food.
http://www.fda.gov/cder/foi/label/2007/021071s023lbl.pdf
increasing insulin sensitivity.
AVANDIA is used in the management of type 2 diabetes mellitus also known as non-
insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes.
AVANDIA improves glycemic control while reducing circulating insulin levels.
Pharmacological studies in animal models indicate that rosiglitazone improves sensitivity to
insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis.
Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the
biguanides, or the alpha-glucosidase inhibitors.
Rosiglitazone, a member of the thiazolidinedione class of antidiabetic agents, improves
glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and
potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ).
In humans, PPAR receptors are found in key target tissues for insulin action such as
adipose tissue, skeletal muscle, and liver.
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, rosiglitazone’s antidiabetic activity was shown to be mediated by
increased sensitivity to insulin’s action in the liver, muscle, and adipose tissues.
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.
The elimination half-life is 3 to 4 hours and is independent of dose.
The absolute bioavailability of rosiglitazone is 99%.
Peak plasma concentrations are observed about 1 hour after dosing.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC),
but there was an approximately 28% decrease in Cmax and a delay in Tmax (1.75 hours).
These changes are not likely to be clinically significant; therefore, AVANDIA may be
administered with or without food.
http://www.fda.gov/cder/foi/label/2007/021071s023lbl.pdf
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risk, personal or otherwise, which is incurred as a
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application of any of the contents of this site.
of its author(s). It is intended to provide helpful and
informative material on the subjects addressed. It is
written with the understanding that the author(s) is
(are) not engaged in rendering medical, health, or
any other kind of professional service(s). The
reader should consult his or her medical, health or
other competent professional before adopting any
of the suggestions. The author(s) specifically
disclaim all responsibility for any liability, loss, or
risk, personal or otherwise, which is incurred as a
consequence, directly or indirectly, of the use and
application of any of the contents of this site.
