Risperdal

Product manufactured by Remedyrepack Inc.

Approved Date Route External Links
2017-06-22 Oral Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Risperdal ® Is An Atypical Antipsychotic Indicated For: Treatment Of Schizophrenia ( 1.1) As Monotherapy Or Adjunctive Therapy With Lithium Or Valproate, For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder ( 1.2) Treatment Of Irritability Associated With Autistic Disorder ( 1.3) 1.1 Schizophrenia Risperdal ® (risperidone) Is Indicated For The Treatment Of Schizophrenia. Efficacy Was Established In 4 Short-Term Trials In Adults, 2 Short-Term Trials In Adolescents (ages 13 To 17 Years), And One Long-Term Maintenance Trial In Adults [see Clinical Studies (14.1)] . 1.2 Bipolar Mania Monotherapy Risperdal ® Is Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In 2 Short-Term Trials In Adults And One Short-Term Trial In Children And Adolescents (ages 10 To 17 Years) [see Clinical Studies (14.2)] . Adjunctive Therapy Risperdal ® Adjunctive Therapy With Lithium Or Valproate Is Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In One Short-Term Trial In Adults [see Clinical Studies (14.3)] . 1.3 Irritability Associated With Autistic Disorder Risperdal ® Is Indicated For The Treatment Of Irritability Associated With Autistic Disorder, Including Symptoms Of Aggression Towards Others, Deliberate Self-Injuriousness, Temper Tantrums, And Quickly Changing Moods. Efficacy Was Established In 3 Short-Term Trials In Children And Adolescents (ages 5 To 17 Years) [see Clinical Studies (14.4)] .

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
2. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
6. Hypromelloses HYPROMELLOSES Unresolved
7. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 0 Total)

None

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