Higher than Physician's Desk Reference (US) doses on atypical antipsychotics.
The Physician's Desk Reference (PDR) was established to provide for the practicing of a complete listing of all medications with the FDA-approved labelling, including dosage recommendations. Perhaps in order to maximise individual usage of medications, pharmaceutical companies have frequently targeted lowest possible doses for FDA approval. However, many patients with a variety of illnesses due to resistance and/or multiple illnesses, may need higher than these dose ranges to maximise therapeutic response. In terms of regularly prescribed atypical antipsychotics released over the past 10 years, only risperidone initially obtained approval for a dose for psychosis (16 mg) higher than that suggested currently (maximum of 8 mg). The dose that was approved for mania was lower: a maximum of 6 mg. The others: respectfully, olanzapine (schizophrenia: 15 mg, mania: 20 mg), quetiapine (schizophrenia: 750 mg; mania: 800 mg), ziprasidone (schizophrenia and mania: 160 mg) and aripiprazole (schizophrenia and mania: 30 mg) obtained approvals for psychosis that may limit adverse events but, at the same time, limit benefits. Other data from various sources (double-blind trials, open-label trials, reviews and case reports) have found safety and/or efficacy for the following maximum doses: olanzapine (40 mg), quetiapine (1600 mg), ziprasidone (320 mg) and aripiprazole (75 mg). Reports above those doses are included, but either are insufficient in numbers or bring up questions on safety. In many situations, feared increase in adverse events were not magnified by use of higher doses.
Goodnick
Paul J
PJ
Department of Psychiatry & Behavioural Sciences, Carrier Clinic, UMDNJ Robert Wood Johnson School of Medicine, 252 CR 601, Belle Mead, NJ 08502, USA. pgoodnick@aol.com
D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D006801:Humans; D011356:Product Labeling; D011618:Psychotic Disorders / Q000188:drug therapy; D012016:Reference Values; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
D014150:Antipsychotic Agents