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Saphris Drug Description
SAPHRIS®
(asenapine) Sublingual Tablets

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 the drug-treated patients of between 1.6
to 1.7 times that seen 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. SAPHRIS® (asenapine) is not approved for
the treatment of patients with dementia-related psychosis [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION
SAPHRIS is a psychotropic agent that is available for
sublingual administration. Asenapine belongs to the class dibenzo-oxepino
pyrroles. The chemical designation is (3aRS,12bRS) -5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-
1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its
molecular formula is C17H16ClNO•C4H4O4
and its molecular weight is 401.84 (free base: 285.8). The chemical structure
is:








Asenapine is a white- to off-white powder.
SAPHRIS is supplied for sublingual administration in tablets
containing 5 mg or 10 mg asenapine; inactive ingredients include gelatin and
mannitol.
Last reviewed on RxList: 8/31/2009




Saphris Drug Description
SAPHRIS®
(asenapine) Sublingual Tablets

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 the drug-treated patients of between 1.6
to 1.7 times that seen 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. SAPHRIS® (asenapine) is not approved for
the treatment of patients with dementia-related psychosis [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION
SAPHRIS is a psychotropic agent that is available for
sublingual administration. Asenapine belongs to the class dibenzo-oxepino
pyrroles. The chemical designation is (3aRS,12bRS) -5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-
1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its
molecular formula is C17H16ClNO•C4H4O4
and its molecular weight is 401.84 (free base: 285.8). The chemical structure
is:








Asenapine is a white- to off-white powder.
SAPHRIS is supplied for sublingual administration in tablets
containing 5 mg or 10 mg asenapine; inactive ingredients include gelatin and
mannitol.
Last reviewed on RxList: 8/31/2009




Saphris Drug Description
SAPHRIS®
(asenapine) Sublingual Tablets

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 the drug-treated patients of between 1.6
to 1.7 times that seen 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. SAPHRIS® (asenapine) is not approved for
the treatment of patients with dementia-related psychosis [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION
SAPHRIS is a psychotropic agent that is available for
sublingual administration. Asenapine belongs to the class dibenzo-oxepino
pyrroles. The chemical designation is (3aRS,12bRS) -5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-
1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its
molecular formula is C17H16ClNO•C4H4O4
and its molecular weight is 401.84 (free base: 285.8). The chemical structure
is:








Asenapine is a white- to off-white powder.
SAPHRIS is supplied for sublingual administration in tablets
containing 5 mg or 10 mg asenapine; inactive ingredients include gelatin and
mannitol.
Last reviewed on RxList: 8/31/2009




Saphris Drug Description
SAPHRIS®
(asenapine) Sublingual Tablets

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 the drug-treated patients of between 1.6
to 1.7 times that seen 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. SAPHRIS® (asenapine) is not approved for
the treatment of patients with dementia-related psychosis [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION
SAPHRIS is a psychotropic agent that is available for
sublingual administration. Asenapine belongs to the class dibenzo-oxepino
pyrroles. The chemical designation is (3aRS,12bRS) -5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-
1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its
molecular formula is C17H16ClNO•C4H4O4
and its molecular weight is 401.84 (free base: 285.8). The chemical structure
is:








Asenapine is a white- to off-white powder.
SAPHRIS is supplied for sublingual administration in tablets
containing 5 mg or 10 mg asenapine; inactive ingredients include gelatin and
mannitol.
Last reviewed on RxList: 8/31/2009




Saphris Drug Description
SAPHRIS®
(asenapine) Sublingual Tablets

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 the drug-treated patients of between 1.6
to 1.7 times that seen 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. SAPHRIS® (asenapine) is not approved for
the treatment of patients with dementia-related psychosis [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION
SAPHRIS is a psychotropic agent that is available for
sublingual administration. Asenapine belongs to the class dibenzo-oxepino
pyrroles. The chemical designation is (3aRS,12bRS) -5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-
1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its
molecular formula is C17H16ClNO•C4H4O4
and its molecular weight is 401.84 (free base: 285.8). The chemical structure
is:








Asenapine is a white- to off-white powder.
SAPHRIS is supplied for sublingual administration in tablets
containing 5 mg or 10 mg asenapine; inactive ingredients include gelatin and
mannitol.
Last reviewed on RxList: 8/31/2009





Other reviews about Saphris on wordpress

Schering-Plough Submits Response To FDA For SAPHRIS(TM) (asenapine) In The Acute Treatment Of Both Schizophrenia And Bipolar I Disorder
  by maciekmaciek5
Schering-Plough Corporation (NYSE: SGP) announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets, which was […]


U.S. FDA Issues Complete Response Letter For SAPHRIS(TM) (ASENAPINE) In The Acute Treatment Of Both Schizophrenia And Bipolar I Disorder
  by maciekmaciek5
Schering-Plough Corporation (NYSE: SGP) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets in the acute […]


Saphris Shows Positive Results in Mentally Impaired
  by Matthew
The Food and Drug Administration said Tuesday that an experimental psychiatric drug, Saphris, appeared to be safe and effective, reported Reuters. Reuters reported that a panel of outside psychiatrists […]


FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder
  by cherished79
 FDA, August 14, 2009 The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to […]


Saphris Approved for Schizophrenia and Bipolar Disorder
  by timeinctemp
FRIDAY, Aug. 14 (HealthDay News) — The drug Saphris (asenapine) has been approved by the U.S. Food and Drug Administration to treat adults with either schizophrenia or bipolar […]


Kenilworth Announces Another Post-Approval Saphris® Result -- Salmon's UP!
  by condor
First, go read the largely manufactured "study press release", relating to Saphris® (asenapine) longer-term treatement, v. a placebo. Yes, the dearth of longer-term, peer-reviewed human studies is […]


A Salmon Rises -- On Pseudoparkinsonism Events In One Quarter Of Studied Saphris® Patients
  by condor
We've been graced with expert commentary, yet again -- on the latest news of a study involving Saphris® (asenapine), New Merck's atypical antipsychotic. Take it away, Salmon: . […]


A Salmon Rises -- On Pseudoparkinsonism Events In One Quarter Of Studied Saphris® Patients
  by condor
We've been graced with expert commentary, yet again -- on the latest news of a study involving Saphris® (asenapine), New Merck's atypical antipsychotic. Take it away, Salmon: . […]


Of Saphris®, And "The Nation's Medicine Chest" -- New Jersey
  by condor
I am sorry -- but I find it more than "just coincidental" that New Jersey (the home state of much of big pharma) is the only state […]


saphris review, part 1
  by lexiconman
the skinny yesterday I was given the dubious honor and pleasure of beginning to try a very new drug - merck/schering-plough's latest atypical antipsychotic, saphris. the effects of saphris are […]



Other reviews about Saphris on web:

SAPHRIS medication is commonly used to treat bipolar I disorder and schizophrenia in adults. Visit SAPHRIS and learn more about common symptoms and treatment. Treatment With SAPHRIS® (asenapine) Sublingual Tablets


Saphris (asenapine) is used to treat the symptoms of schizophrenia and bipolar disorder (manic depression). Includes Saphris side effects, interactions and indications. Saphris Information from Drugs.com


Learn about the prescription medication Saphris (Asenapine Sublingual Tablets), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Saphris (Asenapine Sublingual Tablets) Drug Information: Uses ...


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


The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat ... FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder


Asenapine (Saphris) is a new atypical antipsychotic developed for the treatment of schizophrenia and acute mania associated with bipolar disorder by Schering-Plough after its ... Asenapine - Wikipedia, the free encyclopedia


Saphris an antipsychotic used to treat schizophrenia. Side effects and interactions are available at drugstore.com; plus get home delivery from a trusted and licensed U.S. pharmacy Saphris - drugstore.com. Low prices, side effects, interactions.


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SAPHRIS ® (asenapine) safely and effectively. SAPHRIS® (asenapine) sublingual tablets


Conditions like bipolar disorder and schizophrenia are often treated with the prescription drug Saphris. This eMedTV resource provides a detailed overview of this medication, with ... Saphris


Saphris Information, Learn About Saphris, Saphris Forums, How to Take Saphris, Saphris Side Effects, Saphris Interactions, Discussion Threads, Medication Warnings, Saphris ... Saphris - The People's Medicine Community





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