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Extemporaneous suspension of propafenone: attending lack of pediatric formulations in Mexico.
- Source :
-
Pediatric cardiology [Pediatr Cardiol] 2008 Nov; Vol. 29 (6), pp. 1077-81. Date of Electronic Publication: 2008 Jun 28. - Publication Year :
- 2008
-
Abstract
- Background: Physicians have frequently encountered difficulties when prescribing drugs not available in doses suitable for pediatric age groups. Furthermore, children have difficulty swallowing tablets. This study aimed to determine the stability of an oral propafenone suspension made from commercial tablets with a syrup vehicle and to establish its reliable use with children.<br />Methods: An extemporaneous suspension of propafenone 1.5 mg/ml was prepared with commercial tablets. Its physicochemical and microbiologic stability was established by constant monitoring during 90 days at room temperature (15 +/- 5 degrees C) and at refrigeration (3-5 degrees C). Plasma levels of propafenona were measured in two children with supraventricular tachycardia at steady state.<br />Results: The suspension was stable, maintaining its original physicochemical and microbiologic properties. Moreover, no apparent changes in color or odor were observed. Plasma levels of propafenone in patients demonstrated therapeutic concentrations after they had taken the suspension, with no unwanted outcome.<br />Conclusions: The conservation of both physicochemical and microbiologic stability of the suspension represents an option for the administration of propafenone to children.
- Subjects :
- Administration, Oral
Analysis of Variance
Anti-Arrhythmia Agents chemistry
Chemistry, Pharmaceutical
Child, Preschool
Chromatography, Liquid
Drug Storage
Humans
Infant
Mexico
Propafenone chemistry
Suspensions
Tablets
Anti-Arrhythmia Agents administration & dosage
Arrhythmias, Cardiac drug therapy
Drug Stability
Propafenone administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 0172-0643
- Volume :
- 29
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Pediatric cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 18587605
- Full Text :
- https://doi.org/10.1007/s00246-008-9257-5