Basic Information
ARIPRIP 5 TABLET 5MG
TABLET
Regulatory Information
SIN16593P
September 6, 2022
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XN05AX12
Company Information
Active Ingredients
Strength: 5.00mg
Detailed Information
Contraindications
**CONTRAINDICATION** Hypersensitivity to the active substance or to any of the excipients.
Indication Information
**INDICATIONS AND USAGE** **Schizophrenia** Aripiprazole is indicated for the treatment of schizophrenia. The efficacy of Aripiprazole in the treatment of schizophrenia was established in four short-term (4- and 6-week) controlled trials in adults and one 6-week trial in paediatrics (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to paediatrics _\[see CLINICAL STUDIES_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. The physician who elects to use Aripiprazole for extended periods should periodically re-evaluate the long- term usefulness of the drug for the individual patient _\[see DOSAGE AND ADMINISTRATION\]_. **Bipolar I Disorder** Aripriprazole is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder and for maintaining stability or preventing recurrence, as monotherapy in adults and in adolescents aged 13 years and older, and as an adjunct to lithium or valproate in adults. The efficacy of Aripiprazole as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in paediatric patients. Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults _\[see CLINICAL STUDIES_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults _\[see CLINICAL STUDIES_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Physicians who elect to use Aripiprazole for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient _\[see DOSAGE AND ADMINISTRATION\]_. **Irritability Associated with Autistic Disorder** Aripriprazole is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in paediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) \[see CLINICAL STUDIES – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. The efficacy of Aripriprazole for the maintenance treatment of irritability associated with autistic disorder was not established. **Tourette’s Disorder** Aripriprazole is indicated for the treatment of Tourette’s disorder. Efficacy was established in one 8-week (aged 7 to 17 years) and one 10-week (aged 6 to 18 years) placebo-controlled trial in paediatric patients with Tourette’s disorder \[ _see_ CLINICAL STUDIES) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].