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Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia.
Curr Med Res Opin. 2010 Feb; 26(2):377-87.CM

Abstract

OBJECTIVE

This article overviews the recommended dosing strategies for the treatment of schizophrenia patients using the recently FDA-approved once-monthly long-acting injectable atypical antipsychotic, paliperidone palmitate.

METHODS

Using pharmacokinetic (PK), efficacy and safety data from clinical trials and a comprehensive population PK simulation model, dosing recommendations for paliperidone palmitate have been generated.

RESULTS

The recommended initiation regimen is 150 mg eq. paliperidone palmitate (234 mg) on Day 1 followed by 100 mg eq. paliperidone palmitate (156 mg) on Day 8, each administered into the deltoid muscle, using a 1-inch 23 gauge (G) needle in those <90 kg and a 1.5-inch 22 G needle in those > or =90 kg. No oral supplementation is required. Monthly maintenance doses of paliperidone palmitate range from 25-150 mg eq. (39-234 mg; recommended dose of 75 mg eq. [117 mg]) injected into the deltoid (using weight-adjusted needle) or gluteal (using 1.5 inch 22 G needle) muscle. The Day 8 dose may be administered +/-2 days and monthly doses +/-7 days, without a clinically significant impact on plasma concentrations. In patients with mild renal impairment (creatinine clearance [CrCL]: 50-80 mL/min), dosage should be adjusted. No dose adjustment is required in patients with mild or moderate hepatic impairment; no data currently exist regarding severe hepatic impairment. Elderly patients with normal renal function should receive the same dosage as younger adult patients with normal renal function. In the event of an age-related decline in CrCL, dosage should be adjusted accordingly. Paliperidone palmitate treatment can be initiated the day after discontinuing previous oral antipsychotic treatment. Paliperidone palmitate should be initiated at the next scheduled injection, and monthly thereafter, in patients switching from other long-acting injectable antipsychotics, including long-acting risperidone.

CONCLUSIONS

These data provide practical guidance to clinicians on how to use paliperidone palmitate in adult patients with schizophrenia.

Authors+Show Affiliations

Johnson & Johnson PRD, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA. SGopal2@PRDUS.JNJ.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

20001492

Citation

Gopal, S, et al. "Practical Guidance for Dosing and Switching Paliperidone Palmitate Treatment in Patients With Schizophrenia." Current Medical Research and Opinion, vol. 26, no. 2, 2010, pp. 377-87.
Gopal S, Gassmann-Mayer C, Palumbo J, et al. Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Curr Med Res Opin. 2010;26(2):377-87.
Gopal, S., Gassmann-Mayer, C., Palumbo, J., Samtani, M. N., Shiwach, R., & Alphs, L. (2010). Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Current Medical Research and Opinion, 26(2), 377-87. https://doi.org/10.1185/03007990903482772
Gopal S, et al. Practical Guidance for Dosing and Switching Paliperidone Palmitate Treatment in Patients With Schizophrenia. Curr Med Res Opin. 2010;26(2):377-87. PubMed PMID: 20001492.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. AU - Gopal,S, AU - Gassmann-Mayer,C, AU - Palumbo,J, AU - Samtani,M N, AU - Shiwach,R, AU - Alphs,L, PY - 2009/12/17/entrez PY - 2009/12/17/pubmed PY - 2010/5/1/medline SP - 377 EP - 87 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 26 IS - 2 N2 - OBJECTIVE: This article overviews the recommended dosing strategies for the treatment of schizophrenia patients using the recently FDA-approved once-monthly long-acting injectable atypical antipsychotic, paliperidone palmitate. METHODS: Using pharmacokinetic (PK), efficacy and safety data from clinical trials and a comprehensive population PK simulation model, dosing recommendations for paliperidone palmitate have been generated. RESULTS: The recommended initiation regimen is 150 mg eq. paliperidone palmitate (234 mg) on Day 1 followed by 100 mg eq. paliperidone palmitate (156 mg) on Day 8, each administered into the deltoid muscle, using a 1-inch 23 gauge (G) needle in those <90 kg and a 1.5-inch 22 G needle in those > or =90 kg. No oral supplementation is required. Monthly maintenance doses of paliperidone palmitate range from 25-150 mg eq. (39-234 mg; recommended dose of 75 mg eq. [117 mg]) injected into the deltoid (using weight-adjusted needle) or gluteal (using 1.5 inch 22 G needle) muscle. The Day 8 dose may be administered +/-2 days and monthly doses +/-7 days, without a clinically significant impact on plasma concentrations. In patients with mild renal impairment (creatinine clearance [CrCL]: 50-80 mL/min), dosage should be adjusted. No dose adjustment is required in patients with mild or moderate hepatic impairment; no data currently exist regarding severe hepatic impairment. Elderly patients with normal renal function should receive the same dosage as younger adult patients with normal renal function. In the event of an age-related decline in CrCL, dosage should be adjusted accordingly. Paliperidone palmitate treatment can be initiated the day after discontinuing previous oral antipsychotic treatment. Paliperidone palmitate should be initiated at the next scheduled injection, and monthly thereafter, in patients switching from other long-acting injectable antipsychotics, including long-acting risperidone. CONCLUSIONS: These data provide practical guidance to clinicians on how to use paliperidone palmitate in adult patients with schizophrenia. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/20001492/Practical_guidance_for_dosing_and_switching_paliperidone_palmitate_treatment_in_patients_with_schizophrenia_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007990903482772 DB - PRIME DP - Unbound Medicine ER -