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Blood Levels of Paliperidone Extended-Release Tablets are Not,Increased by Common Antidepressant

psychotics in clinical trials. Paliperidone is not approved for treating these patients.

Orthostatic hypotension and Syncope: Paliperidone can cause orthostatic hypotension and syncope in some patients. Appropriate monitoring of orthostatic vital signs should be considered.

Seizures: Paliperidone should be used cautiously in patients with a history of seizures.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, paliperidone elevates prolactin levels and the elevation persists during chronic administration.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses and close supervision of high-risk patients should accompany drug therapy.

Maintenance treatment: Physicians who elect to use paliperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Given the primary CNS effects of paliperidone, paliperidone should be used with caution in combination with other centrally acting drugs and alcohol. Paliperidone may antagonize the effect of levodopa and other dopamine agonists.

    References

    (1) Berwaerts J, Cleton A, et al. A randomized, open label, single center,

        crossover study of the potential effects of paroxetine on the

        pharmacokinetics of a single dose of paliperidone extended release

th        tablets in healthy subjects. Presented at the 160   Annual Meeting of

        the American Psychiatric Association, San Diego, May 22, 2007

    (2) Green AI, Canuso CM, et al. Detection and management of comorbidity in

        patients with schizophrenia. Psychiatric Clinics of North America 2003

        March; 26(1): 115-39

CONTACT: Ambre Morley of Janssen, L.P., +1-609-730-3429, or amorley1@gpcus.jnj.com

Web site: http://www.janssen.com/
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