Reviews Rosiglitazone Maleate and Metformin HCl


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Avandamet Drug Description
AVANDAMET®
(rosiglitazone maleate and metformin hydrochloride) Tablets

WARNINGS
Rosiglitazone maleate: 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 AVANDAMET, 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 AVANDAMET must be considered.

AVANDAMET is not recommended in patients with symptomatic heart failure.
Initiation of AVANDAMET 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
.]

Metformin hydrochloride:LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious complication that can occur due
to metformin accumulation. The risk increases with conditions such as sepsis,
dehydration, excess alcohol intake, hepatic insufficiency, renal impairment,
and acute congestive heart failure. [See WARNINGS AND PRECAUTIONS.]
Symptoms include malaise, myalgias, respiratory distress, increasing
somnolence, and nonspecific abdominal distress. Laboratory abnormalities
include low pH, increased anion gap and elevated blood lactate. [See WARNINGS
AND PRECAUTIONS.] If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient
immediately [See WARNINGS AND PRECAUTIONS ].



DRUG DESCRIPTION



What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin 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:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness, weakness, headache, confusion, or problems with vision, speech, or...
Read All Potential Side Effects for 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, (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 a 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 C4H11N5•
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 pKa of 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.Last reviewed on RxList: 1/27/2009




Avandamet Drug Description
AVANDAMET®
(rosiglitazone maleate and metformin hydrochloride) Tablets

WARNINGS
Rosiglitazone maleate: 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 AVANDAMET, 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 AVANDAMET must be considered.

AVANDAMET is not recommended in patients with symptomatic heart failure.
Initiation of AVANDAMET 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
.]

Metformin hydrochloride:LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious complication that can occur due
to metformin accumulation. The risk increases with conditions such as sepsis,
dehydration, excess alcohol intake, hepatic insufficiency, renal impairment,
and acute congestive heart failure. [See WARNINGS AND PRECAUTIONS.]
Symptoms include malaise, myalgias, respiratory distress, increasing
somnolence, and nonspecific abdominal distress. Laboratory abnormalities
include low pH, increased anion gap and elevated blood lactate. [See WARNINGS
AND PRECAUTIONS.] If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient
immediately [See WARNINGS AND PRECAUTIONS ].



DRUG DESCRIPTION



What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin 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:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness, weakness, headache, confusion, or problems with vision, speech, or...
Read All Potential Side Effects for 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, (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 a 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 C4H11N5•
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 pKa of 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.Last reviewed on RxList: 1/27/2009




Avandamet Drug Description
AVANDAMET®
(rosiglitazone maleate and metformin hydrochloride) Tablets

WARNINGS
Rosiglitazone maleate: 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 AVANDAMET, 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 AVANDAMET must be considered.

AVANDAMET is not recommended in patients with symptomatic heart failure.
Initiation of AVANDAMET 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
.]

Metformin hydrochloride:LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious complication that can occur due
to metformin accumulation. The risk increases with conditions such as sepsis,
dehydration, excess alcohol intake, hepatic insufficiency, renal impairment,
and acute congestive heart failure. [See WARNINGS AND PRECAUTIONS.]
Symptoms include malaise, myalgias, respiratory distress, increasing
somnolence, and nonspecific abdominal distress. Laboratory abnormalities
include low pH, increased anion gap and elevated blood lactate. [See WARNINGS
AND PRECAUTIONS.] If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient
immediately [See WARNINGS AND PRECAUTIONS ].



DRUG DESCRIPTION



What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin 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:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness, weakness, headache, confusion, or problems with vision, speech, or...
Read All Potential Side Effects for 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, (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 a 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 C4H11N5•
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 pKa of 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.Last reviewed on RxList: 1/27/2009




Avandamet Drug Description
AVANDAMET®
(rosiglitazone maleate and metformin hydrochloride) Tablets

WARNINGS
Rosiglitazone maleate: 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 AVANDAMET, 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 AVANDAMET must be considered.

AVANDAMET is not recommended in patients with symptomatic heart failure.
Initiation of AVANDAMET 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
.]

Metformin hydrochloride:LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious complication that can occur due
to metformin accumulation. The risk increases with conditions such as sepsis,
dehydration, excess alcohol intake, hepatic insufficiency, renal impairment,
and acute congestive heart failure. [See WARNINGS AND PRECAUTIONS.]
Symptoms include malaise, myalgias, respiratory distress, increasing
somnolence, and nonspecific abdominal distress. Laboratory abnormalities
include low pH, increased anion gap and elevated blood lactate. [See WARNINGS
AND PRECAUTIONS.] If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient
immediately [See WARNINGS AND PRECAUTIONS ].



DRUG DESCRIPTION



What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin 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:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness, weakness, headache, confusion, or problems with vision, speech, or...
Read All Potential Side Effects for 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, (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 a 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 C4H11N5•
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 pKa of 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.Last reviewed on RxList: 1/27/2009




Avandamet Drug Description
AVANDAMET®
(rosiglitazone maleate and metformin hydrochloride) Tablets

WARNINGS
Rosiglitazone maleate: 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 AVANDAMET, 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 AVANDAMET must be considered.

AVANDAMET is not recommended in patients with symptomatic heart failure.
Initiation of AVANDAMET 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
.]

Metformin hydrochloride:LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious complication that can occur due
to metformin accumulation. The risk increases with conditions such as sepsis,
dehydration, excess alcohol intake, hepatic insufficiency, renal impairment,
and acute congestive heart failure. [See WARNINGS AND PRECAUTIONS.]
Symptoms include malaise, myalgias, respiratory distress, increasing
somnolence, and nonspecific abdominal distress. Laboratory abnormalities
include low pH, increased anion gap and elevated blood lactate. [See WARNINGS
AND PRECAUTIONS.] If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient
immediately [See WARNINGS AND PRECAUTIONS ].



DRUG DESCRIPTION



What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin 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:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness, weakness, headache, confusion, or problems with vision, speech, or...
Read All Potential Side Effects for 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, (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 a 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 C4H11N5•
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 pKa of 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.Last reviewed on RxList: 1/27/2009





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Learn about Avandamet (Rosiglitazone Maleate and Metformin HCl) - Side Effects, Drug Interactions, Pictures, Patient Information on RxList Avandamet (Rosiglitazone Maleate and Metformin HCl) Patient Drug ...


It is a combination of two drugs - rosiglitazone maleate and metformin HCl. For more information about AVANDAMET, please see Medication Guide and full Prescribing Information. Type 2 Diabetes Medication Resources and important safety information


AVANDAMET (rosiglitazone maleate and metformin HCl) tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes: Rosiglitazone maleate and metformin ... AVANDAMET®(rosiglitazone maleate and metformin hydrochloride)Tablets


Bioequivalence of Avandamet with co-administered rosiglitazone maleate tablets and metformin HCl tablets was demonstrated (see CLINICAL PHARMACOLOGY, Pharmacokinetics). EHS: Mosby's Drug Consult - Drug Updates - Rosiglitazone Maleate ...


AT:L11 PRESCRIBING INFORMATION AVANDAMET ® (rosiglitazone maleate and metformin hydrochloride) Tablets DESCRIPTION AVANDAMET (rosiglitazone maleate and metformin HCl) tablets contain 2 ... rosiglitazone maleate and metformin hydrochloride





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