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Search results for paliperidone in EMA ASSESSMENT REPORTS (approximate match)
Showing 1 - 1 of 1 results
Status:
US Approved Rx
(2015)
Source:
ANDA203802
(2015)
Source URL:
First approved in 2006
Source:
NDA021999
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Paliperidone (9-OH-risperidone) is the primary active metabolite of the older antipsychotic risperidone. While its specific mechanism of action is unknown, it is believed that paliperidone and risperidone act via similar if not the same pathways. It has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism. Paliperidone is also active as an antagonist at alpha 1 and alpha 2 adrenergic receptors and H1 histaminergic receptors, which may explain some of the other effects of the drug. Paliperidone was approved by the FDA for treatment of schizophrenia on December 20, 2006. Very common adverse effects are: headache, tachycardia, somnolence and insomnia.