ABSTRACT
BACKGROUND: Intravenous admixtures of dexketoprofen-trometamol and paracetamol are frequently used in clinical practice due to synergism obtained administering both drugs concomitantly. Physicochemical stability of binary admixture containing both drugs is currently unknown. OBJECTIVE: To determine physicochemical stability of binary admixture containing dexketoprofen-trometamol 50 mg and paracetamol 1000 mg in a low-density polyethylene bottle at different storage conditions of light and temperature for advanced preparation. METHODS: Eight mixtures containing dexketoprofen-trometamol (Enantyum ampule 2 mL) 50 mg and paracetamol (Paracetamol B. Braun bottle 100 mL) 1000 mg were prepared and stored at: room temperature and exposed to light; room temperature and protected from light; refrigerated and exposed to light; and refrigerated and protected from light. From each mixture, aliquots were extracted at different times for 15 days. For physical compatibility, pH measure, gravimetric analysis and visual inspection were carried out. For chemical stability, concentrations of dexketoprofen-trometamol and paracetamol were simultaneously measured by high performance liquid chromatography. RESULTS: Only refrigerated mixtures showed incompatibility since white precipitation appeared at day 6, possibly due to paracetamol instability. Remaining drugs concentrations were in all cases≥90% after 15 days. CONCLUSION: Binary mixture containing paracetamol (100 mL) 1000 mg and dexketoprofen-trometamol (2 mL) 50 mg in a low-density polyethylene bottle is physicochemically stable for 5 days under refrigeration and 15 days at room temperature. By considering also microbial contamination, this mixture can be prepared in advance, 5 days stored refrigerated and 2 days stored at room temperature, being unnecessary protection from light.
ABSTRACT
This article present the experience and outcomes of patients treated with pirfenidone. FVC and DLCO parameters during 12 months were collected in patients treated with pirfenidone. Eight of the ten patients continued treatment until month 12. 7 patients presented at 12 months an adequate response treatment, 1 patient did not achieve therapeutic targets established (improvement or stability). At week 52, our patients had a mean of change in FVC(%) of -2.38±6.93%; patients of clinical trials showed -5.2% and -8.3% treated with pirfenidone and placebo respectively. Higher incidence of adverse effects was observed than clinical trials. Our results show that pirfenidone is a well-tolerated drug, whose toxicity can be controlled by dose adjustment, and it is effective in mild-moderate IPF. Due to no proven effectiveness and safety in medium / long term and the high economic impact, it is necessary to identify those patients who may get more clinical benefits (AU)
Este artículo presenta la experiencia y los resultados de pacientes tratados con pirfenidona. Se obtuvieron parámetros de FVC y DLCO durante 12 meses en pacientes tratados con pirfenidona. Ocho de los diez pacientes continuaron el tratamiento hasta el mes 12. 7 pacientes presentaron a los 12 meses un tratamiento de respuesta adecuada, 1 paciente no logró objetivos terapéuticos establecidos (mejoría o estabilidad). En la semana 52, nuestros pacientes tenían una media de cambio en FVC(%) de - 2.38±6.93%; los pacientes de los ensayos clínicos demostraron-5.2% y- 8.3% tratados con pirfenidona y placebo respectivamente. Se observó mayor incidencia de efectos adversos de los ensayos clínicos. Nuestros resultados muestran que pirfenidona es un fármaco bien tolerado, cuya toxicidad puede ser controlada mediante el ajuste de la dosis, y es eficaz en IPF de leve a moderada. Debido a la no probada eficacia y seguridad a medio/largo plazo y alto impacto económico, es necesario identificar a aquellos pacientes que pueden obtener mayores beneficios clínicos (AU)
