"The US Food and Drug Administration (FDA) has approved pimavanserin tablets (Nuplazid, Acadia Pharmaceuticals) for the treatment of hallucinations and delusions associated with psychosis in Parkinson's disease (PD).
Use in Children: Safety and efficacy have not been established in the pediatric age group; therefore, the use of procyclidine hydrochloride in this age group requires that the potential benefits be weighed against the possible hazards to the child.
The safe use of this drug in pregnancy has not been established; therefore, the use of procyclidine hydrochloride in pregnancy, lactation, or in women of childbearing age requires that the potential benefits be weighed against the possible hazards to the mother and child.
Conditions in which inhibition of the parasympathetic nervous system is undesirable, such as tachycardia and urinary retention (such as may occur with marked prostatic hypertrophy), require special care in the administration of the drug. Hypotensive patients who receive the drug should be observed closely. Occasionally, particularly in older patients, mental confusion and disorientation may occur with the development of agitation, hallucinations, and psychotic-like symptoms. Patients with mental disorders occasionally experience a precipitation of a psychotic episode when the dosage of antiparkinsonism drugs is increased to treat the extrapyramidal side effects of phenothiazine and rauwolfia derivatives.
Clinical studies of KEMADRIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range(see DOSAGE AND ADMINISTRATION) and the dose should be increased only as needed with monitoring for the emergence of adverse events (see ADVERSE REACTIONS).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/1/2011
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