RESUMO
Intravesical oxybutynin chloride has demonstrated its efficacy in children with neurogenic bladder and urinary incontinence refractory to oral anticholinergic agents. We developed a 205 microg/ml oxybutynin chloride solution in accordance with the specifications of the European Pharmacopeae. To guarantee quality, we assessed and validated formulation, the preparation process, and packaging. The solution was obtained by disolving oxybutynin chloride in 0.9% saline and sterile filtration. The solution was then packaged in syringes. Physical properies for intravesical instillation were met: pH 5.76 +/- 0.03, osmolality 281 mosmol/kg. The unit dose package guarantees sterility of the solution until use. The medication is given by adapting the syringe on the Luer Lock exteremity of the urinary catheter. The solution remains stable up to one month at 4 degrees C.
Assuntos
Ácidos Mandélicos/administração & dosagem , Parassimpatolíticos/administração & dosagem , Química Farmacêutica , Estabilidade de Medicamentos , Ácidos Mandélicos/química , Parassimpatolíticos/uso terapêutico , Soluções Farmacêuticas , Controle de QualidadeAssuntos
Rejeição de Enxerto/tratamento farmacológico , Imunossupressores/uso terapêutico , Tacrolimo/uso terapêutico , Imunologia de Transplantes , Adolescente , Adulto , Diabetes Mellitus/epidemiologia , Feminino , Seguimentos , Rejeição de Enxerto/prevenção & controle , Transplante de Coração/imunologia , Hospitais Universitários , Humanos , Imunossupressores/efeitos adversos , Transplante de Rim/imunologia , Transplante de Fígado/imunologia , Transplante de Pulmão/imunologia , Masculino , Pessoa de Meia-Idade , Paris , Complicações Pós-Operatórias , Tacrolimo/efeitos adversos , Fatores de TempoRESUMO
Mycophenolate Mofetil (MMF) is a new immunosuppressant demonstrated to be effective at the dose of 2 to 3 g/day. The objective of this study was to determine whether MMF could be used at a lower dose with the same efficacy. Two patient groups were studied: 334 patients treated with azathioprine (AZA) and 60 patients treated MMF (at the dose of 750 mg/day, for patients receiving triple combination therapy or 1.5 g/day for those receiving two-agent combination therapy). The rest of the treatment was identical for the 2 groups. The main endpoint was the incidence of acute rejection at 3 months, which was 16% in the MMF group and 35% in the AZA group (p = 0.003). Multivariate analysis confirmed the impact of the type of purine synthesis inhibitor used (AZA or MMF, p = 0.007) on the acute rejection rate at 3 months. This study confirms the value of MMF, even at doses lower than those recommended in the international literature, with improved safety. MMF has now replaced azathioprine in our immunosuppressant protocols.