Reviews Paliperidone Palmitate Extended-Release Injectable Suspension


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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 Paliperidone Palmitate Extended-Release Injectable Suspension on web:

Paliperidone Palmitate Extended -Release Injectable Suspension (Invega® Sustenna™) Drug Monograph for Texas Department of State Health Services Drug Monograph for Texas Department of State Health Services


Invega Sustenna (paliperidone palmitate) extended-release injectable suspension Drug Safety Labeling Changes May 2010 Invega Sustenna (paliperidone palmitate) extended-release ...


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 ...


Page 1 Paliperidone Palmitate Extended-Release Injectable Suspension (Invega ® Sustenna TM) Formulary Review Statewide Pharmacy and Therapeutics Committee Friday, November 20, 2009 Ashley ... Paliperidone Palmitate Extended-Release Injectable Suspension ...


Invega Sustenna (paliperidone palmitate) is a long-acting injectable formulation of paliperidone ... INVEGGA Sustenna (paliperidone palmitate Extended Release Injectable Suspension ... Paliperidone - Wikipedia, the free encyclopedia


Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension, Ortho-McNeil-Jansen Pharmaceuticals, Inc. Invega Sustenna (paliperidone palmitate) Extended-Release ... HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not ...


... least 2 doses of oral risperidone or paliperidone extended-release ... Paliperidone palmitate was supplied as 25, 100, or 150 mg eq. injectable suspension (batch numbers ... DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE PALIPERIDONE ...


This new drug application provides for the use of Invega Sustenna (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of ... Sustenna (paliperidone palmitate)


Paliperidone extended-release tablets (below) Paliperidone Oral tablet, extended-release; Paliperidone palmitate Suspension for ... palmitate Extended Release Injectable Suspension) Web ... Paliperidone: Information from Answers.com


Titusville, N.J., July 31, 2009 – The U.S. Food and Drug Administration today approved INVEGA® SUSTENNA™ (paliperidone palmitate) extended-release injectable suspension ... Janssen: News





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