Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Generic Paliperidone Extended-Release

Indicated for schizophrenia in adults, adolescents

A generic form of paliperidone extended-release tablets is now available.

Indications: Paliperidone is an atypical antipsychotic agent indicated for treatment of schizophrenia in adults and adolescents.

Dosage and administration: For adults, initial dose is 6 mg/day, and the recommended dose is 3 to 12 mg/day. For adolescents, the initial dose is 3 mg/day, and the recommended dose is 3 to 12 mg/day depending on weight.

Efficacy and safety: In the branded drug, efficacy was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.

Side effects/risks: Commonly observed adverse reactions were:

• Adults: extrapyramidal symptoms, tachycardia, and akathisia

• Adolescents: somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight increased, and tachycardia

• Adults with schizoaffective disorder: extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis

Source: Highlights of Prescribing Information.

http://www.invega.com/prescribing-information. Accessed October 7, 2015.

http://www.allergan.com/news/news/thomson-reuters/allergan-launches-gene.... Accessed October 7, 2015.