| Autor: |
Anta L; Laboratorios Farmacéuticos ROVI, Madrid, Spain., Llaudó J; Laboratorios Farmacéuticos ROVI, Madrid, Spain., Ayani I; Laboratorios Farmacéuticos ROVI, Madrid, Spain., Martínez J; Laboratorios Farmacéuticos ROVI, Madrid, Spain., Litman RE; CBH Health, LLC, Rockville, Maryland, USA., Gutierro I; Laboratorios Farmacéuticos ROVI, Madrid, Spain. |
| Jazyk: |
angličtina |
| Zdroj: |
International clinical psychopharmacology [Int Clin Psychopharmacol] 2018 Mar; Vol. 33 (2), pp. 79-87. |
| DOI: |
10.1097/YIC.0000000000000203 |
| Abstrakt: |
This study characterized the pharmacokinetics, safety, and tolerability of Risperidone ISM, a new long-acting intramuscular formulation, for monthly administration without oral supplementation. Patients with schizophrenia received multiple intramuscular injections of 75 mg in the gluteal or deltoid muscle at 28-day intervals. Of the 70 randomized patients, 67 received at least one dose of study medication. The mean Cmax of the active moiety was achieved 24-48 h (tmax) after each administration, regardless of injection site. They ranged over four consecutive doses from 39.6 to 53.2 and 54.1 to 61 ng/ml, when given in gluteal or deltoid muscle, respectively. Active moiety achieved therapeutic levels by 2 h after dose, and the levels were maintained throughout the 4-week dosing period. No significant changes across the study were observed on either Positive and Negative Syndrome Scale or Extrapyramidal Symptoms Scale. Overall, 63 (94%) patients experienced at least one treatment-emergent adverse event (TEAE). One serious TEAE (dystonia) was related to study treatment. The most frequently reported TEAEs were hyperprolactinaemia (57.7%) and injection site pain (32.8%). Risperidone ISM achieved therapeutic levels from the first hours after drug administration and provided a sustained release throughout the 4-week dosing period over multiple intramuscular injections and was found to be safe and well tolerated. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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