Reviews Rosiglitazone Maleate and Glimepiride


No reviews yet.

Avandaryl Drug Description
AVANDARYL®
(rosiglitazone maleate and glimepiride) Tablets

WARNING
CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive
heart failure in some patients [see WARNINGS AND PRECAUTIONS].
After initiation of AVANDARYL, and after dose increases, observe patients
carefully for signs and symptoms of heart failure (including excessive,
rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop,
the heart failure should be managed according to current standards of care.
Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure.
Initiation of AVANDARYL in patients with established NYHA Class III or IV
heart failure is contraindicated. [See CONTRAINDICATIONS
and WARNINGS AND PRECAUTIONS.] A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared rosiglitazone to placebo, showed
rosiglitazone to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. Three other studies (mean
duration 41 months; 14,067 total patients), comparing rosiglitazone to some
other approved oral antidiabetic agents or placebo, have not confirmed or
excluded this risk. In their entirety, the available data on the risk of
myocardial ischemia are inconclusive. [See WARNINGS AND PRECAUTIONS.]


DRUG DESCRIPTION



What are the possible side effects of glimepiride and rosiglitazone (Avandaryl)?

Stop using glimepiride and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
vision problems;
chest pain or heavy feeling, pain spreading to the arm or...
Read All Potential Side Effects for Avandaryl »




AVANDARYL contains 2 oral antidiabetic drugs used in the management of type
2 diabetes: rosiglitazone maleate and glimepiride.
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. 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,
(Z)-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 C18H19N3O3S•C4H4O4.
Rosiglitazone maleate is a white to off-white solid with a melting point range
of 122° to 123°C. The pKa 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:








Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Glimepiride
is a white to yellowish-white, crystalline, odorless to practically odorless
powder. Chemically, glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans4-methylcyclohexyl) urea
with a molecular weight of 490.62. The molecular formula for glimepiride is
C24H34N4O5S. Glimepiride is practically
insoluble in water. The structural formula of glimepiride is:








AVANDARYL is available for oral administration as tablets containing rosiglitazone
maleate and glimepiride, respectively, in the following strengths (expressed
as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2
mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients:
Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide,
and 1 or more of the following: Yellow, red, or black iron oxides.
Last reviewed on RxList: 12/21/2009




Avandaryl Drug Description
AVANDARYL®
(rosiglitazone maleate and glimepiride) Tablets

WARNING
CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive
heart failure in some patients [see WARNINGS AND PRECAUTIONS].
After initiation of AVANDARYL, and after dose increases, observe patients
carefully for signs and symptoms of heart failure (including excessive,
rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop,
the heart failure should be managed according to current standards of care.
Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure.
Initiation of AVANDARYL in patients with established NYHA Class III or IV
heart failure is contraindicated. [See CONTRAINDICATIONS
and WARNINGS AND PRECAUTIONS.] A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared rosiglitazone to placebo, showed
rosiglitazone to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. Three other studies (mean
duration 41 months; 14,067 total patients), comparing rosiglitazone to some
other approved oral antidiabetic agents or placebo, have not confirmed or
excluded this risk. In their entirety, the available data on the risk of
myocardial ischemia are inconclusive. [See WARNINGS AND PRECAUTIONS.]


DRUG DESCRIPTION



What are the possible side effects of glimepiride and rosiglitazone (Avandaryl)?

Stop using glimepiride and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
vision problems;
chest pain or heavy feeling, pain spreading to the arm or...
Read All Potential Side Effects for Avandaryl »




AVANDARYL contains 2 oral antidiabetic drugs used in the management of type
2 diabetes: rosiglitazone maleate and glimepiride.
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. 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,
(Z)-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 C18H19N3O3S•C4H4O4.
Rosiglitazone maleate is a white to off-white solid with a melting point range
of 122° to 123°C. The pKa 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:








Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Glimepiride
is a white to yellowish-white, crystalline, odorless to practically odorless
powder. Chemically, glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans4-methylcyclohexyl) urea
with a molecular weight of 490.62. The molecular formula for glimepiride is
C24H34N4O5S. Glimepiride is practically
insoluble in water. The structural formula of glimepiride is:








AVANDARYL is available for oral administration as tablets containing rosiglitazone
maleate and glimepiride, respectively, in the following strengths (expressed
as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2
mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients:
Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide,
and 1 or more of the following: Yellow, red, or black iron oxides.
Last reviewed on RxList: 12/21/2009




Avandaryl Drug Description
AVANDARYL®
(rosiglitazone maleate and glimepiride) Tablets

WARNING
CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive
heart failure in some patients [see WARNINGS AND PRECAUTIONS].
After initiation of AVANDARYL, and after dose increases, observe patients
carefully for signs and symptoms of heart failure (including excessive,
rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop,
the heart failure should be managed according to current standards of care.
Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure.
Initiation of AVANDARYL in patients with established NYHA Class III or IV
heart failure is contraindicated. [See CONTRAINDICATIONS
and WARNINGS AND PRECAUTIONS.] A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared rosiglitazone to placebo, showed
rosiglitazone to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. Three other studies (mean
duration 41 months; 14,067 total patients), comparing rosiglitazone to some
other approved oral antidiabetic agents or placebo, have not confirmed or
excluded this risk. In their entirety, the available data on the risk of
myocardial ischemia are inconclusive. [See WARNINGS AND PRECAUTIONS.]


DRUG DESCRIPTION



What are the possible side effects of glimepiride and rosiglitazone (Avandaryl)?

Stop using glimepiride and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
vision problems;
chest pain or heavy feeling, pain spreading to the arm or...
Read All Potential Side Effects for Avandaryl »




AVANDARYL contains 2 oral antidiabetic drugs used in the management of type
2 diabetes: rosiglitazone maleate and glimepiride.
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. 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,
(Z)-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 C18H19N3O3S•C4H4O4.
Rosiglitazone maleate is a white to off-white solid with a melting point range
of 122° to 123°C. The pKa 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:








Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Glimepiride
is a white to yellowish-white, crystalline, odorless to practically odorless
powder. Chemically, glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans4-methylcyclohexyl) urea
with a molecular weight of 490.62. The molecular formula for glimepiride is
C24H34N4O5S. Glimepiride is practically
insoluble in water. The structural formula of glimepiride is:








AVANDARYL is available for oral administration as tablets containing rosiglitazone
maleate and glimepiride, respectively, in the following strengths (expressed
as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2
mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients:
Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide,
and 1 or more of the following: Yellow, red, or black iron oxides.
Last reviewed on RxList: 12/21/2009




Avandaryl Drug Description
AVANDARYL®
(rosiglitazone maleate and glimepiride) Tablets

WARNING
CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive
heart failure in some patients [see WARNINGS AND PRECAUTIONS].
After initiation of AVANDARYL, and after dose increases, observe patients
carefully for signs and symptoms of heart failure (including excessive,
rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop,
the heart failure should be managed according to current standards of care.
Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure.
Initiation of AVANDARYL in patients with established NYHA Class III or IV
heart failure is contraindicated. [See CONTRAINDICATIONS
and WARNINGS AND PRECAUTIONS.] A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared rosiglitazone to placebo, showed
rosiglitazone to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. Three other studies (mean
duration 41 months; 14,067 total patients), comparing rosiglitazone to some
other approved oral antidiabetic agents or placebo, have not confirmed or
excluded this risk. In their entirety, the available data on the risk of
myocardial ischemia are inconclusive. [See WARNINGS AND PRECAUTIONS.]


DRUG DESCRIPTION



What are the possible side effects of glimepiride and rosiglitazone (Avandaryl)?

Stop using glimepiride and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
vision problems;
chest pain or heavy feeling, pain spreading to the arm or...
Read All Potential Side Effects for Avandaryl »




AVANDARYL contains 2 oral antidiabetic drugs used in the management of type
2 diabetes: rosiglitazone maleate and glimepiride.
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. 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,
(Z)-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 C18H19N3O3S•C4H4O4.
Rosiglitazone maleate is a white to off-white solid with a melting point range
of 122° to 123°C. The pKa 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:








Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Glimepiride
is a white to yellowish-white, crystalline, odorless to practically odorless
powder. Chemically, glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans4-methylcyclohexyl) urea
with a molecular weight of 490.62. The molecular formula for glimepiride is
C24H34N4O5S. Glimepiride is practically
insoluble in water. The structural formula of glimepiride is:








AVANDARYL is available for oral administration as tablets containing rosiglitazone
maleate and glimepiride, respectively, in the following strengths (expressed
as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2
mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients:
Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide,
and 1 or more of the following: Yellow, red, or black iron oxides.
Last reviewed on RxList: 12/21/2009




Avandaryl Drug Description
AVANDARYL®
(rosiglitazone maleate and glimepiride) Tablets

WARNING
CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive
heart failure in some patients [see WARNINGS AND PRECAUTIONS].
After initiation of AVANDARYL, and after dose increases, observe patients
carefully for signs and symptoms of heart failure (including excessive,
rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop,
the heart failure should be managed according to current standards of care.
Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure.
Initiation of AVANDARYL in patients with established NYHA Class III or IV
heart failure is contraindicated. [See CONTRAINDICATIONS
and WARNINGS AND PRECAUTIONS.] A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared rosiglitazone to placebo, showed
rosiglitazone to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. Three other studies (mean
duration 41 months; 14,067 total patients), comparing rosiglitazone to some
other approved oral antidiabetic agents or placebo, have not confirmed or
excluded this risk. In their entirety, the available data on the risk of
myocardial ischemia are inconclusive. [See WARNINGS AND PRECAUTIONS.]


DRUG DESCRIPTION



What are the possible side effects of glimepiride and rosiglitazone (Avandaryl)?

Stop using glimepiride and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
vision problems;
chest pain or heavy feeling, pain spreading to the arm or...
Read All Potential Side Effects for Avandaryl »




AVANDARYL contains 2 oral antidiabetic drugs used in the management of type
2 diabetes: rosiglitazone maleate and glimepiride.
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. 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,
(Z)-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 C18H19N3O3S•C4H4O4.
Rosiglitazone maleate is a white to off-white solid with a melting point range
of 122° to 123°C. The pKa 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:








Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Glimepiride
is a white to yellowish-white, crystalline, odorless to practically odorless
powder. Chemically, glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans4-methylcyclohexyl) urea
with a molecular weight of 490.62. The molecular formula for glimepiride is
C24H34N4O5S. Glimepiride is practically
insoluble in water. The structural formula of glimepiride is:








AVANDARYL is available for oral administration as tablets containing rosiglitazone
maleate and glimepiride, respectively, in the following strengths (expressed
as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2
mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients:
Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide,
and 1 or more of the following: Yellow, red, or black iron oxides.
Last reviewed on RxList: 12/21/2009





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Other reviews about Rosiglitazone Maleate and Glimepiride on web:

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVANDARYL safely and effectively. See full prescribing information for ... rosiglitazone maleate and glimepiride


Learn about the prescription medication Avandaryl (Rosiglitazone Maleate and Glimepiride), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling Avandaryl (Rosiglitazone Maleate and Glimepiride) Drug Information ...


Rosiglitazone Maleate/Glimepiride professional patient advice. Specific and up to date information about Rosiglitazone Maleate/Glimepiride. Complete Rosiglitazone Maleate/Glimepiride information from Drugs.com


Avandaryl (Rosiglitazone Maleate / Glimepiride) - Warnings and Precautions ... (See CLINICAL PHARMACOLOGY, Drug Interactions, Rosiglitazone.) Glimepiride Avandaryl (Rosiglitazone / Glimepiride) - Warnings and Precautions


The information on this page is seed content provided by an organization. Please help improve this Article by adding to it. If you are a physician or PhD, learn how to edit. If you ... Clinical:Avandaryl (rosiglitazone maleate and glimepiride) - Medpedia


Tablets: Each tablet contains rosiglitazone as the maleate and glimepiride as follows: 4 mg/1 mg − yellow, rounded triangular tablet, gsk debossed on one side and 4/1 on the other Avandaryl (Rosiglitazone / Glimepiride) - Indications and Dosage


Section Contents Menu. MedWatch The FDA Safety Information and Adverse Event Reporting Program; Safety Information; Safety Alerts for Human Medical Products Avandaryl (rosiglitazone maleate and glimepiride)


►Avandia (rosiglitazone maleate) ►Avandamet (rosiglitazone maleate and metformin hydrochloride) ►Avandaryl (rosiglitazone maleate and glimepiride) Avandia Law Firm


Avandaryl (rosiglitazone maleate and glimepiride) tablets Drug Safety Labeling Changes November 2009 Avandaryl (rosiglitazone maleate and glimepiride) tablets


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVANDARYL safely and effectively. See full prescribing information for ... AVANDARYL® (rosiglitazone maleate and glimepiride) Tablets





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