Reviews Actoplus MET, Actoplus MET XR


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Actoplus MET, Actoplus MET XR Drug Description
ACTOPLUS MET®
(pioglitazone hydrochloride and metformin hydrochloride) Tablets
ACTOPLUS MET® XR
(pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
Congestive Heart Failure

Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS
MET and ACTOPLUS MET XR, cause or exacerbate congestive heart failure in
some patients (see WARNINGS, Pioglitazone).
After initiation of ACTOPLUS MET or ACTOPLUS MET XR, 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 the current
standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS
MET or ACTOPLUS MET XR must be considered.
ACTOPLUS MET and ACTOPLUS MET XR are not recommended in patients with symptomatic
heart failure. Initiation of ACTOPLUS MET or ACTOPLUS MET XR in patients
with established NYHA Class III or IV heart failure is contraindicated (see
CONTRAINDICATIONS and WARNINGS,
Pioglitazone).

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.
The onset is often subtle, accompanied only by nonspecific symptoms such
as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific
abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated
blood lactate.
If acidosis is suspected, ACTOPLUS MET or ACTOPLUS MET XR should be discontinued
and the patient hospitalized immediately (see WARNINGS,
Metformin Hydrochloride).


DRUG DESCRIPTION



What are the possible side effects of metformin and pioglitazone (Actoplus Met)?

Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
Stop using metformin and pioglitazone 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...
Read All Potential Side Effects for Actoplus MET, Actoplus MET XR »




ACTOPLUS MET® tablets are formulated with pioglitazone hydrochloride and immediate-release metformin hydrochloride. ACTOPLUS MET® XR tablets are formulated with pioglitazone hydrochloride and extended-release metformin hydrochloride. Both ACTOPLUS MET® and ACTOPLUS MET® XR contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone and metformin. ACTOPLUS MET® is available in 15 mg pioglitazone/500 mg metformin hydrochloride and 15 mg pioglitazone/850 mg metformin hydrochloride tablets. ACTOPLUS MET® XR is available in 15 mg pioglitazone/1000 mg extended-release metformin hydrochloride and 30 mg pioglitazone/1000 mg extended-release metformin hydrochloride tablets.
Pioglitazone is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.
Pioglitazone (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione
monohydrochloride belongs to a different chemical class and has a different
pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase
inhibitors. The molecule contains one asymmetric center, and the synthetic compound
is a racemate. The two enantiomers of pioglitazone interconvert in vivo.
The structural formula is as shown:








Pioglitazone hydrochloride is an odorless white crystalline powder that has
a molecular formula of C19H20N2O3S•HCl
and a molecular weight of 392.90. It is soluble in N,N-dimethylformamide,
slightly soluble in anhydrous ethanol, very slightly soluble in acetone and
acetonitrile, practically insoluble in water, and insoluble in ether.
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride)
is not chemically or pharmacologically related to any other classes of oral
antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder
with a molecular formula of C4H11N5•HCl
and a molecular weight of 165.62. 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 is as shown:








ACTOPLUS MET is available as a tablet for oral administration containing pioglitazone hydrochloride and metformin hydrochloride equivalent to 15 mg pioglitazone and 500 mg metformin hydrochloride (ACTOPLUS MET 15 mg/500 mg) or 850 mg metformin hydrochloride (ACTOPLUS MET 15 mg/850 mg). ACTOPLUS MET is formulated with the following excipients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc.
ACTOPLUS MET XR is available as a tablet for once-a-day oral administration
containing pioglitazone hydrochloride and metformin hydrochloride equivalent
to 15 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS MET XR 15
mg/1000 mg) or 30 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS
MET XR 30 mg/1000 mg). ACTOPLUS MET XR is formulated with the following excipients:
candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400,
PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Tablets are
imprinted with ink containing shellac, iron oxide red (15 mg/1000 mg strength
only), FD&C Blue No. 2 Lake (30 mg/1000 mg strength only), propylene glycol,
and ammonium hydroxide.
Actoplus Met Xr: System Components And Performance
ACTOPLUS MET XR consists of an extended-release metformin core coated tablet with an immediate-release pioglitazone layer. The metformin core tablet is an extended-release formulation using the patented single composition osmotic technology (SCOT™) for once-daily (q.d.) oral administration. The tablet is similar in appearance to other film-coated oral administered tablets but it consists of an osmotically active core formulation that is surrounded by a semipermeable membrane and coated with a pioglitazone drug layer. Two laser drilled exit ports exist in the membrane, one on either side of the tablet. The core formulation is composed primarily of drug with small concentrations of excipients. The semipermeable membrane is permeable to water but not to higher molecular weight components of biological fluids. Upon ingestion, the pioglitazone layer is dissolved, water is then taken up through the membrane, which in turn dissolves the metformin and excipients in the core formulation. The dissolved metformin and excipients exit through the laser drilled ports in the membrane. The rate of drug delivery is constant and dependent upon the maintenance of a constant osmotic gradient across the membrane. This situation exists so long as there is undissolved metformin present in the core tablet. Following the dissolution of the core materials, the rate of drug delivery slowly decreases until the osmotic gradient across the membrane falls to zero at which time delivery ceases. The membrane coating remains intact during the transit of the dosage form through the gastrointestinal tract and is excreted in the feces.
Last reviewed on RxList: 6/25/2009




Actoplus MET, Actoplus MET XR Drug Description
ACTOPLUS MET®
(pioglitazone hydrochloride and metformin hydrochloride) Tablets
ACTOPLUS MET® XR
(pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
Congestive Heart Failure

Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS
MET and ACTOPLUS MET XR, cause or exacerbate congestive heart failure in
some patients (see WARNINGS, Pioglitazone).
After initiation of ACTOPLUS MET or ACTOPLUS MET XR, 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 the current
standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS
MET or ACTOPLUS MET XR must be considered.
ACTOPLUS MET and ACTOPLUS MET XR are not recommended in patients with symptomatic
heart failure. Initiation of ACTOPLUS MET or ACTOPLUS MET XR in patients
with established NYHA Class III or IV heart failure is contraindicated (see
CONTRAINDICATIONS and WARNINGS,
Pioglitazone).

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.
The onset is often subtle, accompanied only by nonspecific symptoms such
as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific
abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated
blood lactate.
If acidosis is suspected, ACTOPLUS MET or ACTOPLUS MET XR should be discontinued
and the patient hospitalized immediately (see WARNINGS,
Metformin Hydrochloride).


DRUG DESCRIPTION



What are the possible side effects of metformin and pioglitazone (Actoplus Met)?

Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
Stop using metformin and pioglitazone 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...
Read All Potential Side Effects for Actoplus MET, Actoplus MET XR »




ACTOPLUS MET® tablets are formulated with pioglitazone hydrochloride and immediate-release metformin hydrochloride. ACTOPLUS MET® XR tablets are formulated with pioglitazone hydrochloride and extended-release metformin hydrochloride. Both ACTOPLUS MET® and ACTOPLUS MET® XR contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone and metformin. ACTOPLUS MET® is available in 15 mg pioglitazone/500 mg metformin hydrochloride and 15 mg pioglitazone/850 mg metformin hydrochloride tablets. ACTOPLUS MET® XR is available in 15 mg pioglitazone/1000 mg extended-release metformin hydrochloride and 30 mg pioglitazone/1000 mg extended-release metformin hydrochloride tablets.
Pioglitazone is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.
Pioglitazone (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione
monohydrochloride belongs to a different chemical class and has a different
pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase
inhibitors. The molecule contains one asymmetric center, and the synthetic compound
is a racemate. The two enantiomers of pioglitazone interconvert in vivo.
The structural formula is as shown:








Pioglitazone hydrochloride is an odorless white crystalline powder that has
a molecular formula of C19H20N2O3S•HCl
and a molecular weight of 392.90. It is soluble in N,N-dimethylformamide,
slightly soluble in anhydrous ethanol, very slightly soluble in acetone and
acetonitrile, practically insoluble in water, and insoluble in ether.
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride)
is not chemically or pharmacologically related to any other classes of oral
antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder
with a molecular formula of C4H11N5•HCl
and a molecular weight of 165.62. 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 is as shown:








ACTOPLUS MET is available as a tablet for oral administration containing pioglitazone hydrochloride and metformin hydrochloride equivalent to 15 mg pioglitazone and 500 mg metformin hydrochloride (ACTOPLUS MET 15 mg/500 mg) or 850 mg metformin hydrochloride (ACTOPLUS MET 15 mg/850 mg). ACTOPLUS MET is formulated with the following excipients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc.
ACTOPLUS MET XR is available as a tablet for once-a-day oral administration
containing pioglitazone hydrochloride and metformin hydrochloride equivalent
to 15 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS MET XR 15
mg/1000 mg) or 30 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS
MET XR 30 mg/1000 mg). ACTOPLUS MET XR is formulated with the following excipients:
candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400,
PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Tablets are
imprinted with ink containing shellac, iron oxide red (15 mg/1000 mg strength
only), FD&C Blue No. 2 Lake (30 mg/1000 mg strength only), propylene glycol,
and ammonium hydroxide.
Actoplus Met Xr: System Components And Performance
ACTOPLUS MET XR consists of an extended-release metformin core coated tablet with an immediate-release pioglitazone layer. The metformin core tablet is an extended-release formulation using the patented single composition osmotic technology (SCOT™) for once-daily (q.d.) oral administration. The tablet is similar in appearance to other film-coated oral administered tablets but it consists of an osmotically active core formulation that is surrounded by a semipermeable membrane and coated with a pioglitazone drug layer. Two laser drilled exit ports exist in the membrane, one on either side of the tablet. The core formulation is composed primarily of drug with small concentrations of excipients. The semipermeable membrane is permeable to water but not to higher molecular weight components of biological fluids. Upon ingestion, the pioglitazone layer is dissolved, water is then taken up through the membrane, which in turn dissolves the metformin and excipients in the core formulation. The dissolved metformin and excipients exit through the laser drilled ports in the membrane. The rate of drug delivery is constant and dependent upon the maintenance of a constant osmotic gradient across the membrane. This situation exists so long as there is undissolved metformin present in the core tablet. Following the dissolution of the core materials, the rate of drug delivery slowly decreases until the osmotic gradient across the membrane falls to zero at which time delivery ceases. The membrane coating remains intact during the transit of the dosage form through the gastrointestinal tract and is excreted in the feces.
Last reviewed on RxList: 6/25/2009




Actoplus MET, Actoplus MET XR Drug Description
ACTOPLUS MET®
(pioglitazone hydrochloride and metformin hydrochloride) Tablets
ACTOPLUS MET® XR
(pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
Congestive Heart Failure

Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS
MET and ACTOPLUS MET XR, cause or exacerbate congestive heart failure in
some patients (see WARNINGS, Pioglitazone).
After initiation of ACTOPLUS MET or ACTOPLUS MET XR, 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 the current
standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS
MET or ACTOPLUS MET XR must be considered.
ACTOPLUS MET and ACTOPLUS MET XR are not recommended in patients with symptomatic
heart failure. Initiation of ACTOPLUS MET or ACTOPLUS MET XR in patients
with established NYHA Class III or IV heart failure is contraindicated (see
CONTRAINDICATIONS and WARNINGS,
Pioglitazone).

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.
The onset is often subtle, accompanied only by nonspecific symptoms such
as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific
abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated
blood lactate.
If acidosis is suspected, ACTOPLUS MET or ACTOPLUS MET XR should be discontinued
and the patient hospitalized immediately (see WARNINGS,
Metformin Hydrochloride).


DRUG DESCRIPTION



What are the possible side effects of metformin and pioglitazone (Actoplus Met)?

Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
Stop using metformin and pioglitazone 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...
Read All Potential Side Effects for Actoplus MET, Actoplus MET XR »




ACTOPLUS MET® tablets are formulated with pioglitazone hydrochloride and immediate-release metformin hydrochloride. ACTOPLUS MET® XR tablets are formulated with pioglitazone hydrochloride and extended-release metformin hydrochloride. Both ACTOPLUS MET® and ACTOPLUS MET® XR contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone and metformin. ACTOPLUS MET® is available in 15 mg pioglitazone/500 mg metformin hydrochloride and 15 mg pioglitazone/850 mg metformin hydrochloride tablets. ACTOPLUS MET® XR is available in 15 mg pioglitazone/1000 mg extended-release metformin hydrochloride and 30 mg pioglitazone/1000 mg extended-release metformin hydrochloride tablets.
Pioglitazone is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.
Pioglitazone (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione
monohydrochloride belongs to a different chemical class and has a different
pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase
inhibitors. The molecule contains one asymmetric center, and the synthetic compound
is a racemate. The two enantiomers of pioglitazone interconvert in vivo.
The structural formula is as shown:








Pioglitazone hydrochloride is an odorless white crystalline powder that has
a molecular formula of C19H20N2O3S•HCl
and a molecular weight of 392.90. It is soluble in N,N-dimethylformamide,
slightly soluble in anhydrous ethanol, very slightly soluble in acetone and
acetonitrile, practically insoluble in water, and insoluble in ether.
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride)
is not chemically or pharmacologically related to any other classes of oral
antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder
with a molecular formula of C4H11N5•HCl
and a molecular weight of 165.62. 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 is as shown:








ACTOPLUS MET is available as a tablet for oral administration containing pioglitazone hydrochloride and metformin hydrochloride equivalent to 15 mg pioglitazone and 500 mg metformin hydrochloride (ACTOPLUS MET 15 mg/500 mg) or 850 mg metformin hydrochloride (ACTOPLUS MET 15 mg/850 mg). ACTOPLUS MET is formulated with the following excipients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc.
ACTOPLUS MET XR is available as a tablet for once-a-day oral administration
containing pioglitazone hydrochloride and metformin hydrochloride equivalent
to 15 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS MET XR 15
mg/1000 mg) or 30 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS
MET XR 30 mg/1000 mg). ACTOPLUS MET XR is formulated with the following excipients:
candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400,
PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Tablets are
imprinted with ink containing shellac, iron oxide red (15 mg/1000 mg strength
only), FD&C Blue No. 2 Lake (30 mg/1000 mg strength only), propylene glycol,
and ammonium hydroxide.
Actoplus Met Xr: System Components And Performance
ACTOPLUS MET XR consists of an extended-release metformin core coated tablet with an immediate-release pioglitazone layer. The metformin core tablet is an extended-release formulation using the patented single composition osmotic technology (SCOT™) for once-daily (q.d.) oral administration. The tablet is similar in appearance to other film-coated oral administered tablets but it consists of an osmotically active core formulation that is surrounded by a semipermeable membrane and coated with a pioglitazone drug layer. Two laser drilled exit ports exist in the membrane, one on either side of the tablet. The core formulation is composed primarily of drug with small concentrations of excipients. The semipermeable membrane is permeable to water but not to higher molecular weight components of biological fluids. Upon ingestion, the pioglitazone layer is dissolved, water is then taken up through the membrane, which in turn dissolves the metformin and excipients in the core formulation. The dissolved metformin and excipients exit through the laser drilled ports in the membrane. The rate of drug delivery is constant and dependent upon the maintenance of a constant osmotic gradient across the membrane. This situation exists so long as there is undissolved metformin present in the core tablet. Following the dissolution of the core materials, the rate of drug delivery slowly decreases until the osmotic gradient across the membrane falls to zero at which time delivery ceases. The membrane coating remains intact during the transit of the dosage form through the gastrointestinal tract and is excreted in the feces.
Last reviewed on RxList: 6/25/2009




Actoplus MET, Actoplus MET XR Drug Description
ACTOPLUS MET®
(pioglitazone hydrochloride and metformin hydrochloride) Tablets
ACTOPLUS MET® XR
(pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
Congestive Heart Failure

Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS
MET and ACTOPLUS MET XR, cause or exacerbate congestive heart failure in
some patients (see WARNINGS, Pioglitazone).
After initiation of ACTOPLUS MET or ACTOPLUS MET XR, 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 the current
standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS
MET or ACTOPLUS MET XR must be considered.
ACTOPLUS MET and ACTOPLUS MET XR are not recommended in patients with symptomatic
heart failure. Initiation of ACTOPLUS MET or ACTOPLUS MET XR in patients
with established NYHA Class III or IV heart failure is contraindicated (see
CONTRAINDICATIONS and WARNINGS,
Pioglitazone).

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.
The onset is often subtle, accompanied only by nonspecific symptoms such
as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific
abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated
blood lactate.
If acidosis is suspected, ACTOPLUS MET or ACTOPLUS MET XR should be discontinued
and the patient hospitalized immediately (see WARNINGS,
Metformin Hydrochloride).


DRUG DESCRIPTION



What are the possible side effects of metformin and pioglitazone (Actoplus Met)?

Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
Stop using metformin and pioglitazone 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...
Read All Potential Side Effects for Actoplus MET, Actoplus MET XR »




ACTOPLUS MET® tablets are formulated with pioglitazone hydrochloride and immediate-release metformin hydrochloride. ACTOPLUS MET® XR tablets are formulated with pioglitazone hydrochloride and extended-release metformin hydrochloride. Both ACTOPLUS MET® and ACTOPLUS MET® XR contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone and metformin. ACTOPLUS MET® is available in 15 mg pioglitazone/500 mg metformin hydrochloride and 15 mg pioglitazone/850 mg metformin hydrochloride tablets. ACTOPLUS MET® XR is available in 15 mg pioglitazone/1000 mg extended-release metformin hydrochloride and 30 mg pioglitazone/1000 mg extended-release metformin hydrochloride tablets.
Pioglitazone is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.
Pioglitazone (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione
monohydrochloride belongs to a different chemical class and has a different
pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase
inhibitors. The molecule contains one asymmetric center, and the synthetic compound
is a racemate. The two enantiomers of pioglitazone interconvert in vivo.
The structural formula is as shown:








Pioglitazone hydrochloride is an odorless white crystalline powder that has
a molecular formula of C19H20N2O3S•HCl
and a molecular weight of 392.90. It is soluble in N,N-dimethylformamide,
slightly soluble in anhydrous ethanol, very slightly soluble in acetone and
acetonitrile, practically insoluble in water, and insoluble in ether.
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride)
is not chemically or pharmacologically related to any other classes of oral
antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder
with a molecular formula of C4H11N5•HCl
and a molecular weight of 165.62. 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 is as shown:








ACTOPLUS MET is available as a tablet for oral administration containing pioglitazone hydrochloride and metformin hydrochloride equivalent to 15 mg pioglitazone and 500 mg metformin hydrochloride (ACTOPLUS MET 15 mg/500 mg) or 850 mg metformin hydrochloride (ACTOPLUS MET 15 mg/850 mg). ACTOPLUS MET is formulated with the following excipients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc.
ACTOPLUS MET XR is available as a tablet for once-a-day oral administration
containing pioglitazone hydrochloride and metformin hydrochloride equivalent
to 15 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS MET XR 15
mg/1000 mg) or 30 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS
MET XR 30 mg/1000 mg). ACTOPLUS MET XR is formulated with the following excipients:
candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400,
PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Tablets are
imprinted with ink containing shellac, iron oxide red (15 mg/1000 mg strength
only), FD&C Blue No. 2 Lake (30 mg/1000 mg strength only), propylene glycol,
and ammonium hydroxide.
Actoplus Met Xr: System Components And Performance
ACTOPLUS MET XR consists of an extended-release metformin core coated tablet with an immediate-release pioglitazone layer. The metformin core tablet is an extended-release formulation using the patented single composition osmotic technology (SCOT™) for once-daily (q.d.) oral administration. The tablet is similar in appearance to other film-coated oral administered tablets but it consists of an osmotically active core formulation that is surrounded by a semipermeable membrane and coated with a pioglitazone drug layer. Two laser drilled exit ports exist in the membrane, one on either side of the tablet. The core formulation is composed primarily of drug with small concentrations of excipients. The semipermeable membrane is permeable to water but not to higher molecular weight components of biological fluids. Upon ingestion, the pioglitazone layer is dissolved, water is then taken up through the membrane, which in turn dissolves the metformin and excipients in the core formulation. The dissolved metformin and excipients exit through the laser drilled ports in the membrane. The rate of drug delivery is constant and dependent upon the maintenance of a constant osmotic gradient across the membrane. This situation exists so long as there is undissolved metformin present in the core tablet. Following the dissolution of the core materials, the rate of drug delivery slowly decreases until the osmotic gradient across the membrane falls to zero at which time delivery ceases. The membrane coating remains intact during the transit of the dosage form through the gastrointestinal tract and is excreted in the feces.
Last reviewed on RxList: 6/25/2009




Actoplus MET, Actoplus MET XR Drug Description
ACTOPLUS MET®
(pioglitazone hydrochloride and metformin hydrochloride) Tablets
ACTOPLUS MET® XR
(pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
Congestive Heart Failure

Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS
MET and ACTOPLUS MET XR, cause or exacerbate congestive heart failure in
some patients (see WARNINGS, Pioglitazone).
After initiation of ACTOPLUS MET or ACTOPLUS MET XR, 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 the current
standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS
MET or ACTOPLUS MET XR must be considered.
ACTOPLUS MET and ACTOPLUS MET XR are not recommended in patients with symptomatic
heart failure. Initiation of ACTOPLUS MET or ACTOPLUS MET XR in patients
with established NYHA Class III or IV heart failure is contraindicated (see
CONTRAINDICATIONS and WARNINGS,
Pioglitazone).

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.
The onset is often subtle, accompanied only by nonspecific symptoms such
as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific
abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated
blood lactate.
If acidosis is suspected, ACTOPLUS MET or ACTOPLUS MET XR should be discontinued
and the patient hospitalized immediately (see WARNINGS,
Metformin Hydrochloride).


DRUG DESCRIPTION



What are the possible side effects of metformin and pioglitazone (Actoplus Met)?

Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
Stop using metformin and pioglitazone 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...
Read All Potential Side Effects for Actoplus MET, Actoplus MET XR »




ACTOPLUS MET® tablets are formulated with pioglitazone hydrochloride and immediate-release metformin hydrochloride. ACTOPLUS MET® XR tablets are formulated with pioglitazone hydrochloride and extended-release metformin hydrochloride. Both ACTOPLUS MET® and ACTOPLUS MET® XR contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone and metformin. ACTOPLUS MET® is available in 15 mg pioglitazone/500 mg metformin hydrochloride and 15 mg pioglitazone/850 mg metformin hydrochloride tablets. ACTOPLUS MET® XR is available in 15 mg pioglitazone/1000 mg extended-release metformin hydrochloride and 30 mg pioglitazone/1000 mg extended-release metformin hydrochloride tablets.
Pioglitazone is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.
Pioglitazone (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione
monohydrochloride belongs to a different chemical class and has a different
pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase
inhibitors. The molecule contains one asymmetric center, and the synthetic compound
is a racemate. The two enantiomers of pioglitazone interconvert in vivo.
The structural formula is as shown:








Pioglitazone hydrochloride is an odorless white crystalline powder that has
a molecular formula of C19H20N2O3S•HCl
and a molecular weight of 392.90. It is soluble in N,N-dimethylformamide,
slightly soluble in anhydrous ethanol, very slightly soluble in acetone and
acetonitrile, practically insoluble in water, and insoluble in ether.
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride)
is not chemically or pharmacologically related to any other classes of oral
antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder
with a molecular formula of C4H11N5•HCl
and a molecular weight of 165.62. 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 is as shown:








ACTOPLUS MET is available as a tablet for oral administration containing pioglitazone hydrochloride and metformin hydrochloride equivalent to 15 mg pioglitazone and 500 mg metformin hydrochloride (ACTOPLUS MET 15 mg/500 mg) or 850 mg metformin hydrochloride (ACTOPLUS MET 15 mg/850 mg). ACTOPLUS MET is formulated with the following excipients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc.
ACTOPLUS MET XR is available as a tablet for once-a-day oral administration
containing pioglitazone hydrochloride and metformin hydrochloride equivalent
to 15 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS MET XR 15
mg/1000 mg) or 30 mg pioglitazone and 1000 mg metformin hydrochloride (ACTOPLUS
MET XR 30 mg/1000 mg). ACTOPLUS MET XR is formulated with the following excipients:
candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400,
PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Tablets are
imprinted with ink containing shellac, iron oxide red (15 mg/1000 mg strength
only), FD&C Blue No. 2 Lake (30 mg/1000 mg strength only), propylene glycol,
and ammonium hydroxide.
Actoplus Met Xr: System Components And Performance
ACTOPLUS MET XR consists of an extended-release metformin core coated tablet with an immediate-release pioglitazone layer. The metformin core tablet is an extended-release formulation using the patented single composition osmotic technology (SCOT™) for once-daily (q.d.) oral administration. The tablet is similar in appearance to other film-coated oral administered tablets but it consists of an osmotically active core formulation that is surrounded by a semipermeable membrane and coated with a pioglitazone drug layer. Two laser drilled exit ports exist in the membrane, one on either side of the tablet. The core formulation is composed primarily of drug with small concentrations of excipients. The semipermeable membrane is permeable to water but not to higher molecular weight components of biological fluids. Upon ingestion, the pioglitazone layer is dissolved, water is then taken up through the membrane, which in turn dissolves the metformin and excipients in the core formulation. The dissolved metformin and excipients exit through the laser drilled ports in the membrane. The rate of drug delivery is constant and dependent upon the maintenance of a constant osmotic gradient across the membrane. This situation exists so long as there is undissolved metformin present in the core tablet. Following the dissolution of the core materials, the rate of drug delivery slowly decreases until the osmotic gradient across the membrane falls to zero at which time delivery ceases. The membrane coating remains intact during the transit of the dosage form through the gastrointestinal tract and is excreted in the feces.
Last reviewed on RxList: 6/25/2009





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