Reviews Invega Sustenna


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Invega Sustenna Drug Description
INVEGA® SUSTENNA®
(paliperidone palmitate) Extended-Release Injectable Suspension

WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials
(modal duration of 10 weeks), largely in patients taking atypical antipsychotic
drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7
times the risk of death in placebo-treated patients. Over the course of a typical
10-week controlled trial, the rate of death in drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes
of death were varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs,
treatment with conventional antipsychotic drugs may increase mortality. The
extent to which the findings of increased mortality in observational studies
may be attributed to the antipsychotic drug as opposed to some characteristic(s)
of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate)
is not approved for the treatment of patients with dementia-related psychosis.
[See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION
INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient,
paliperidone palmitate, is a psychotropic agent belonging to the chemical class
of benzisoxazole derivatives. INVEGA® SUSTENNA® contains a racemic mixture
of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl
hexadecanoate. Its molecular formula is C39H57FN4O4
and its molecular weight is 664.89. The structural formula is:








Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically
insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble
in ethyl acetate.
INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous
extended-release suspension for intramuscular injection in dose strengths of
39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The drug product
hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of
25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive
ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate,
disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate,
sodium hydroxide, and water for injection.
INVEGA® SUSTENNA® is provided in a prefilled syringe (cyclic-olefin-copolymer)
with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains
2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety
needle).
Last reviewed on RxList: 6/10/2010 2:38:32 PM




Invega Sustenna Drug Description
INVEGA® SUSTENNA®
(paliperidone palmitate) Extended-Release Injectable Suspension

WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials
(modal duration of 10 weeks), largely in patients taking atypical antipsychotic
drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7
times the risk of death in placebo-treated patients. Over the course of a typical
10-week controlled trial, the rate of death in drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes
of death were varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs,
treatment with conventional antipsychotic drugs may increase mortality. The
extent to which the findings of increased mortality in observational studies
may be attributed to the antipsychotic drug as opposed to some characteristic(s)
of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate)
is not approved for the treatment of patients with dementia-related psychosis.
[See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION
INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient,
paliperidone palmitate, is a psychotropic agent belonging to the chemical class
of benzisoxazole derivatives. INVEGA® SUSTENNA® contains a racemic mixture
of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl
hexadecanoate. Its molecular formula is C39H57FN4O4
and its molecular weight is 664.89. The structural formula is:








Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically
insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble
in ethyl acetate.
INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous
extended-release suspension for intramuscular injection in dose strengths of
39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The drug product
hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of
25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive
ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate,
disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate,
sodium hydroxide, and water for injection.
INVEGA® SUSTENNA® is provided in a prefilled syringe (cyclic-olefin-copolymer)
with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains
2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety
needle).
Last reviewed on RxList: 6/10/2010 2:38:32 PM




Invega Sustenna Drug Description
INVEGA® SUSTENNA®
(paliperidone palmitate) Extended-Release Injectable Suspension

WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials
(modal duration of 10 weeks), largely in patients taking atypical antipsychotic
drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7
times the risk of death in placebo-treated patients. Over the course of a typical
10-week controlled trial, the rate of death in drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes
of death were varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs,
treatment with conventional antipsychotic drugs may increase mortality. The
extent to which the findings of increased mortality in observational studies
may be attributed to the antipsychotic drug as opposed to some characteristic(s)
of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate)
is not approved for the treatment of patients with dementia-related psychosis.
[See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION
INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient,
paliperidone palmitate, is a psychotropic agent belonging to the chemical class
of benzisoxazole derivatives. INVEGA® SUSTENNA® contains a racemic mixture
of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl
hexadecanoate. Its molecular formula is C39H57FN4O4
and its molecular weight is 664.89. The structural formula is:








Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically
insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble
in ethyl acetate.
INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous
extended-release suspension for intramuscular injection in dose strengths of
39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The drug product
hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of
25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive
ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate,
disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate,
sodium hydroxide, and water for injection.
INVEGA® SUSTENNA® is provided in a prefilled syringe (cyclic-olefin-copolymer)
with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains
2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety
needle).
Last reviewed on RxList: 6/10/2010 2:38:32 PM




Invega Sustenna Drug Description
INVEGA® SUSTENNA®
(paliperidone palmitate) Extended-Release Injectable Suspension

WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials
(modal duration of 10 weeks), largely in patients taking atypical antipsychotic
drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7
times the risk of death in placebo-treated patients. Over the course of a typical
10-week controlled trial, the rate of death in drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes
of death were varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs,
treatment with conventional antipsychotic drugs may increase mortality. The
extent to which the findings of increased mortality in observational studies
may be attributed to the antipsychotic drug as opposed to some characteristic(s)
of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate)
is not approved for the treatment of patients with dementia-related psychosis.
[See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION
INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient,
paliperidone palmitate, is a psychotropic agent belonging to the chemical class
of benzisoxazole derivatives. INVEGA® SUSTENNA® contains a racemic mixture
of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl
hexadecanoate. Its molecular formula is C39H57FN4O4
and its molecular weight is 664.89. The structural formula is:








Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically
insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble
in ethyl acetate.
INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous
extended-release suspension for intramuscular injection in dose strengths of
39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The drug product
hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of
25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive
ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate,
disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate,
sodium hydroxide, and water for injection.
INVEGA® SUSTENNA® is provided in a prefilled syringe (cyclic-olefin-copolymer)
with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains
2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety
needle).
Last reviewed on RxList: 6/10/2010 2:38:32 PM




Invega Sustenna Drug Description
INVEGA® SUSTENNA®
(paliperidone palmitate) Extended-Release Injectable Suspension

WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials
(modal duration of 10 weeks), largely in patients taking atypical antipsychotic
drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7
times the risk of death in placebo-treated patients. Over the course of a typical
10-week controlled trial, the rate of death in drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes
of death were varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs,
treatment with conventional antipsychotic drugs may increase mortality. The
extent to which the findings of increased mortality in observational studies
may be attributed to the antipsychotic drug as opposed to some characteristic(s)
of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate)
is not approved for the treatment of patients with dementia-related psychosis.
[See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION
INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient,
paliperidone palmitate, is a psychotropic agent belonging to the chemical class
of benzisoxazole derivatives. INVEGA® SUSTENNA® contains a racemic mixture
of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl
hexadecanoate. Its molecular formula is C39H57FN4O4
and its molecular weight is 664.89. The structural formula is:








Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically
insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble
in ethyl acetate.
INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous
extended-release suspension for intramuscular injection in dose strengths of
39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The drug product
hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of
25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive
ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate,
disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate,
sodium hydroxide, and water for injection.
INVEGA® SUSTENNA® is provided in a prefilled syringe (cyclic-olefin-copolymer)
with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains
2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety
needle).
Last reviewed on RxList: 6/10/2010 2:38:32 PM





Other reviews about Invega Sustenna on wordpress

Sustained-Release Antipsychotic Approved for Schizophrenia
  by timeinctemp
MONDAY, Aug. 3 (HealthDay News) — Invega Sustenna (paliperidone palmitate) has been approved by the U.S. Food and Drug Administration to treat schizophrenia, drug maker Janssen said in […]


Sustained-Release Antipsychotic Approved for Schizophrenia
  by akamine2525
Invega Sustenna (paliperidone palmitate) has been approved by the U.S. Food and Drug Administration to treat schizophrenia, drug maker Janssen said in a news release. The longer-acting […]


Ortho-McNeil-Janssen Drops Development of Monthly Injectable Risperdal
  by abellve
According to PharmLive, manufacturer Alkermes, Inc. was recently informed that Ortho-Mcneil-Janssen (commonly known as Janssen), a branch of Johnson & Johnson, has dropped development of a 4 week […]



Other reviews about Invega Sustenna on web:

Learn more about INVEGA® SUSTENNA®, a treatment option. Talk to your doctor today. Learn more about INVEGA® SUSTENNA® (paliperidone palmitate)


Accurate, FDA approved Invega Sustenna information for healthcare professionals and patients - brought to you by Drugs.com. Invega Sustenna Official FDA information, side effects and uses.


All about Invega Sustenna. View complete and up to date Invega Sustenna information - part of the Drugs.com trusted medication database. Invega Sustenna Facts and Comparisons at Drugs.com


Paliperidone (sold as INVEGA, INVEGA Sustenna), also known as 9-hydroxyrisperidone, is an atypical antipsychotic developed by Janssen Pharmaceutica. Paliperidone - Wikipedia, the free encyclopedia


Read recent news releases issued by Janssen. ... FDA Approves INVEGA® SUSTENNA™ for the Acute and Maintenance Treatment of Schizophrenia Janssen: News


Invega Sustenna Janssen ... Has anyone hurd of anything about the new Invega shot coming out called Invega Sustenna. Invega Sustenna - Cafepharma Message Boards


Learn about the prescription medication Invega Sustenna (Paliperidone Palmitate Extended-Release Injectable Suspension), drug uses, dosage, side effects, drug interactions ... Invega Sustenna (Paliperidone Palmitate Extended-Release ...


FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia. INVEGA(R) SUSTENNA(TM) is the First Once-Monthly Atypical Antipsychotic Approved for ... FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance ...


FDA Approves INVEGA ® SUSTENNA™ for the Acute and Maintenance Treatment of Schizophrenia . INVEGA ® SUSTENNA™ is the First Once-Monthly Atypical Antipsychotic Approved for ... FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance ...


The U.S. Food and Drug Administration approved INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of ... FDA Approves INVEGA(R) SUSTENNA(TM) For The Acute And Maintenance ...





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