Paliperidone

What it is used for

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia Adults: Efficacy was established in three 6-week trials and one maintenance trial. Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Efficacy was established in two 6-week trials in adult patients. Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.

Schizoaffective Disorder Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy. The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults. Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia.

The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. Schizoaffective Disorder Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy.

The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.

Side effects, and when to stop

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Increased mortality in elderly patients with dementia-related psychosis
• Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis
• Neuroleptic malignant syndrome
• QT prolongation
• Tardive dyskinesia
• Metabolic changes
• Hyperprolactinemia
• Potential for gastrointestinal obstruction
• Orthostatic hypotension and syncope
• Falls
• Leukopenia, neutropenia, and agranulocytosis
• Potential for cognitive and motor impairment
• Seizures
• Dysphagia
• Priapism
• Disruption of body temperature regulation

Who should not take it

INVEGA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

Storing it

Storage and Handling

Store up to 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). Protect from moisture.

Keep out of reach of children.