CoChat
Sign Up
Cited by 19Schizophrenia research and treatmentPharmaceutical studies and practicesPharmacogenetics and Drug Metabolism

The Pharmacokinetics of Second-Generation Long-Acting Injectable Antipsychotics: Limitations of Monograph Values

Lee, Lik Hang N., Choi, Charles, Collier, Abby C., Barr, Alasdair M., Honer, William G., Procyshyn, Ric M.·2015·CNS Drugs
DOI 10.1007/s40263-015-0295-2
Open this paper in CoChat — free account

Abstract

Product monographs (also known by terms such as Summary of Product Characteristics and Highlights of Prescribing Information, depending on the jurisdiction) provide essential information to ensure the safe and effective use of a drug. Medical practitioners often rely on these monographs for guidance on matters related to pharmacokinetics as well as indications, contraindications, clinical pharmacology, and adverse reactions. The clinical and scientific information found within these documents, forming the basis for decision making, are presumed to be derived from well-designed studies. The objective of this review is to examine the source and validity of the pharmacokinetic data used in establishing the half-lives and times to steady-state reported in the product monographs of second-generation long-acting injectable antipsychotics. Thus, we have critically evaluated the clinical trials from which the pharmacokinetic parameters listed in the product monographs were determined. In many cases, the pharmacokinetic information presented in product monographs is of limited use to clinicians wishing to optimize the effectiveness and tolerability of second-generation long-acting injectable antipsychotics. Under such circumstances, off-label prescribing practices may actually produce better clinical outcomes than if decisions were made based on the product monographs alone.

Integrity signals

Registry

Crossref · 10.1007/s40263-015-0295-2

Cites

20 of 20 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The half-life described in the RLAI-MS monograph represents the rate of absorption after the burst and lag phases, which limits the clinical significance of this parameter.

    “The half-life described in the monograph represents the rate of absorption after the burst and lag phases, which limits the clinical significance of this parameter [89].”

    From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [89]

  • During the initial burst phase after intramuscular injection of RLAI-MS, a small initial release of drug (<1% of the dose) occurs, which is then followed by a 3-week lag phase of minimal drug release.

    “During the initial “burst” phase after intramuscular injection, a small initial release of drug (< 1% of the dose) occurs, which is then followed by a 3-week “lag” phase of minimal drug release [89].”

    From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [89]

  • Although a slow rate of absorption is the rate-limiting step in defining apparent half-life and time to steady state for most LAIs, this is not the case for RLAI-MS, which exhibits a triphasic release profile.

    “Although a slow rate of absorption is the rate-limiting step in defining apparent half-life and time to steady state for most LAIs, this is not the case for RLAI-MS, which exhibits a triphasic release profile.”

    From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [89]

  • New acute withdrawal symptoms after ketamine discontinuation have been described: craving, dysphoria, shaking, sweating, palpitations, tiredness, low appetite, low mood, chills, autonomic arousal, lacrimation, restlessness, anxiety, nightmares, paranoia, delusions, and hallucinations.

    “New acute withdrawal symptoms after ketamine discontinuation have been described. They are craving, dysphoria, shaking, sweating, palpitations, tiredness, low appetite, low mood, chills, autonomic arousal, lacrimation, restlessness, anxiety, nightmares, paranoia, delusions, and hallucinations [145-147].”

    From Acute and Persistent Withdrawal Syndromes Following Discontinuation of Psychotropic Medications (2020) · cites this paper as [146]

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Lee, L. H. N., Choi, C., Collier, A. C., Barr, A. M., Honer, W. G., & Procyshyn, R. M.
Affiliations
University of British Columbia (CA)
Corresponding author
Procyshyn, Ric M.
ORCID
Venue
CNS Drugs
Publisher
Springer Science and Business Media LLC
Published
2015-11-19
Volume
29
Issue
12
Pages
975-983
ISSN
  • 1172-7047 (ISSN-L)
  • 1179-1934
DOI
10.1007/s40263-015-0295-2
OpenAlex
W2251665514
Cited by
19
References
20
Citations by year
2025: 2 · 2023: 2 · 2021: 5 · 2020: 1 · 2019: 2 · 2018: 2 · 2017: 3 · 2016: 2
FWCI
1.89
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • CNS Drugs (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Institute of Health Services and Policy Research (CA)
  • British Columbia Mental Health and Substance Use Services
  • Jack Bell Chair in Schizophrenia
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
Keywords
long-acting injectable antipsychotics, atypical antipsychotics, pharmacokinetics, Summary of Product Characteristics, half-life, time to steady state, clinical trial validity, off-label drug use, prescribing information
MeSH terms
Animals, Half-Life, Humans, Injections, Antipsychotic Agents

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review