INVEGA SUMMARY
INVEGA™ (paliperidone) Extended-Release Tablets
Paliperidone, the active ingredient in INVEGA™ Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA™ contains a racemic mixture of (+)- and (-)- paliperidone.
INVEGA™ (paliperidone) Extended-Release Tablets is indicated for the acute and maintenance treatment of schizophrenia.
The efficacy of INVEGA™ in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled, fixed-dose trials in subjects with schizophrenia.
The longer-term benefit of maintaining schizophrenic patients on monotherapy with INVEGATM after achieving a responder status for 6 weeks was demonstrated in a controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use paliperidone for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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