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Clinical evidence of the antiarrhythmic effect of a magistral suspension of propafenone: A case report
Evidencia clínica del efecto antiarrítmico de una suspensión extemporánea de propafenona. Reporte de un caso
Lina Barranco-Garduñoa, Janett Flores-Pérezb, Hugo Juárez-Olguínc, Jesús Bobadilla-Chávezd, Héctor Osnayae, Carmen Flores-Pérezf
a Laboratorio de Farmacología, Instituto Nacional de Pediatría (INP). México, D.F. México. Departamento de Farmacología, Facultad de Medicina, Universidad Nacional Autónoma de México. México, D.F.
b Laboratorio de Farmacología, Instituto Nacional de Pediatría (INP). México, D.F. México. Departamento de Farmacología, Facultad de Medicina, Universidad Nacional Autónoma de México. México, D.F.
c Laboratorio de Farmacología, Instituto Nacional de Pediatría (INP). México, D.F. México. Departamento de Farmacología, Facultad de Medicina, Universidad Nacional Autónoma de México. México, D.F.
d Servicio de Cardiología, INP.
e Servicio de Cardiología, INP.
f Laboratorio de Farmacología, Instituto Nacional de Pediatría (INP). México, D.F. México.
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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Introduction</span></p><p class="elsevierStylePara">Supraventricular tachycardia &#40;SVT&#41; is frequently manifested in emergency pediatric care units and is difficult to solve because the hemodynamic state of the patient may be involved&#46; </p><p class="elsevierStylePara">The frequency of this disorder ranges from 1 in 250 to 1000 children&#46;<span class="elsevierStyleSup">1</span> Forty percent of children who has SVT suffer from factors that predispose them to this condition&#44; such as congenital heart disease&#44; Wolff-Parkinson-White &#40;WPW&#41; syndrome&#44; infections&#44; fever or adverse reactions due to exposure to various different drugs&#46; SVT is characterized by episodes of rapid cardiac rhythm caused by abnormal electrical circuits in the heart&#46; The electrocardiogram &#40;EKG&#41; shows short PR interval&#44; delta wave and complex prolongation of QRS&#46; Propafenone is beta-blocking drug recommended for the treatment of SVT&#46; It acts as a potent sodium channel blocker and is a weak b-adrenergic and calcium antagonist&#46; Its main electro-physiological effect is to slow down conduction in tissues of quick response&#46; Due its main electrophysiological effects&#44; propafenone has a wide spectrum of activity and efficacy for the treatment against SVT including those of the WPW syndrome and recurrent atrial fibrillation&#46; It has also been used safely in the treatment o various tachyarrhythmias among children&#46;<span class="elsevierStyleSup">2</span> The efficacy and safety of propafenone for the treatment of infantile arrhythmia has been reported&#44; with an average dose of 300mg&#47;m<span class="elsevierStyleSup">2</span>&#47;day &#40;ranging from 250-400 ng&#47;mL&#41; every 8h&#46;<span class="elsevierStyleSup">3</span> Children with SVT were successfully treated with this drug without adverse or proarrhythmic effects&#46; Due to its pharmacokinetic characteristics&#44; propafenone has variable bioavailability when taken orally&#46;<span class="elsevierStyleSup">4</span> The therapeutic plasmatic concentrations are between 0&#46;2 and 1&#46;5&#181;g&#47; mL&#44; following a dose of 150-200 mg&#47;m<span class="elsevierStyleSup">2</span>&#47;day&#44; with a dose increase of up to 600 mg&#47;m<span class="elsevierStyleSup">2</span>&#47;day&#46;<span class="elsevierStyleSup">5</span> Its elimination is of 11 mL&#47;min&#47;kg&#46; Though uncommon&#44; especially in cases of very high doses&#44; adverse effects include lack of appetite&#44; bloating sensation&#44; feeling of nausea&#44; bitter taste&#44; and in some cases blurred vision and dizziness&#46;<span class="elsevierStyleSup">6</span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">Clinical case</span></p><p class="elsevierStylePara">The case of a 2-year-old boy&#44; born and resident in <span class="elsevierStyleItalic">Xochimilco&#44; Mexico City&#44;</span> who had been given cardiological health care at the National Pediatric Institute from May 2005 &#40;since the age of four months&#41; is described&#46; The boy was diagnosed with secondary SVT of the WPW syndrome&#44; and treated with a magistral suspension of propafenone&#44; starting May 2005&#46; The drug was prepared according to an approved formula tested previously in laboratory studies&#46;<span class="elsevierStyleSup">7</span> The mother is an apparently healthy 29-year-old housewife&#59; the father&#44; aged 31 years&#44; has a degree in hotel administration&#44; is apparently healthy and smokes 3&#47;24&#44; whilst denying alcoholism or drug addiction&#46; The parents mentioned genetic inheritance of arterial hypertension on the paternal side and the patient has an apparently healthy 4- year-old brother&#46; </p><p class="elsevierStylePara">This child is the outcome of a second pregnancy&#44; which evolved normally with prenatal control from the first term of gestation&#44; and the mother reported consuming iron and folic acid&#46; It is reported that during the 37th week of gestation&#44; an abdominal ultrasound was carried out which indicated extreme fetal suffering&#44; due to nuchal cord&#44; which required an urgent cesarean section to be carried out on February 16&#44; 2005&#44; producing a single outcome&#44; with an Apgar score of 7&#47;9&#44; at 37 weeks of gestation&#44; weight of 2&#46;500 kg&#44; size 49 cm&#44; without any complications at birth&#44; the child and mother left the hospital 72 hours later&#46; He was breast fed until the end of the first year&#44; taking solids at 6 months&#44; and is currently incorporated into the family diet&#44; which includes&#59; vegetable consumption 3-4&#47;7&#44; fruit 7&#47;7&#44; red meat 4&#47;7 and green vegetables 3&#47;7&#44; egg 1&#47;7&#44; milk and derivatives 3&#47;7&#44; pulses 1&#47;7&#46; He does not eat lentils or beans&#44; only in soup&#46; Psycho-motor development was as follows&#58; social smile at four months&#44; sitting up at 6&#47;2&#44; crawling 8&#47;2&#44; with walking now in process&#46; His vaccines are complete&#46;</p><p class="elsevierStylePara">His current illness began on May 11&#44; 2005&#44; suffering from tachycardia&#44; sweating and indications of poor perfusion&#44; suffering from sweating with a cardiac frequency of 310 per minute and general signs of poor perfusion&#59; together resulting in a diagnosis of SVT&#46; </p><p class="elsevierStylePara">After non effective vagal stimulation maneuvers&#44; propafenone was administered intravenously&#44; however&#44; due to unsuccessful therapeutic actions&#44; patient underwent one attempt of transthoracic electrical cardioversion to restore normal sinus rhythm &#40;<span class="elsevierStyleBold">Figure 1</span>&#41;&#46;</p><p class="elsevierStylePara"><img src="293v79n02-13145963fig1.jpg" alt="Figure 1 Electrocardiogram with supraventricular tachycardia taken before the propafenone treatment"></img></p><p class="elsevierStylePara"><span class="elsevierStyleBold">Figure 1</span> Electrocardiogram with supraventricular tachycardia taken before the propafenone treatment</p><p class="elsevierStylePara">The child was placed in the Intensive Therapy Unit to monitor and stabilize hemodynamic activity and was discharged on May 15&#44; 2005&#46; From the time he was placed in hospital&#44; he received treatment with a magistral suspension of propafenone as previously was mentioned&#44; he received at the beginning 3 mg&#47;8h for 4 months&#44; followed by 6 mg&#47;8h&#44; and finally 11 mg&#47;8h&#46; He has been without symptoms for the last year&#46; <span class="elsevierStyleBold">Figure 1</span> shows an EKG with SVT that was taken before propafenone treatment&#46; <span class="elsevierStyleBold">Figure 2</span> shows the current EKG with SVT of the patient after one year of treatment with propafenone suspension&#46; </p><p class="elsevierStylePara"><img src="293v79n02-13145963fig2.jpg" alt="Figure 2 Current electrocardiogram of the patient with supraventricular tachycardia after one year of treatment with propafenone suspension"></img></p><p class="elsevierStylePara"><span class="elsevierStyleBold">Figure 2</span> Current electrocardiogram of the patient with supraventricular tachycardia after one year of treatment with propafenone suspension</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Discussion</span></p><p class="elsevierStylePara">Research undertaken in the pharmacological laboratory of the National Pediatric Institute includes the development and evaluation of drugs at adequate doses for pediatric use&#44; which are currently not available in our country&#46; On this occasion&#44; a magistral suspension was prepared using commercial tablets&#46; The suspension was prepared by grinding 1 tablet of 150 mg of hydrochloride propafenone &#40;Norfenon&#44; Abbott Lab&#44; Mexico&#41; in a mortar&#46; The finely ground tablets were then powdered and forced to pass through a mesh &#40;size 100&#41; in order to homogenize the particle size&#46; Pomegranate syrup &#40;La Madrile&#241;a&#44; Mexico&#41;&#44; which was used as diluent&#44; was added to obtain a final concentration of 1&#46;5 mg&#47;mL of propafenone&#46; </p><p class="elsevierStylePara">The obtained suspension was subjected to stability tests over a 90 day period&#44; stored at room temperature &#40;15 &#177; 5 &#176;C&#41; and refrigeration &#40;3-5 &#176;C&#41;&#44; and turned out to be stable&#59; neither physicochemical changes nor microbiological growth were observed&#46; High performance liquid chromatography was used to validate dosage and to determinate the plasmatic levels of the drug&#46;<span class="elsevierStyleSup">8</span></p><p class="elsevierStylePara">Previous to this study we carried out an analysis of the bioavailability of the suspension utilized for the present study compared with commercial tablets&#46;<span class="elsevierStyleSup">7</span> The results of that study showed acceptable value of bioavailability as previously reported&#46;<span class="elsevierStyleSup">9</span> Results demonstrate the reliability to administrate the drug&#46; Plasma levels observed in children with SVT reached concentrations after they took the suspension&#46; There are not reports in children that mention therapeutics range of propafenone&#44; in this study we found that plasma concentration of drug was correlated with the clinical improvement of patients&#46; The EKG done simultaneously during monitoring of propafenone showed an improvement respect initial exam reported during the diagnostic process&#46;</p><p class="elsevierStylePara">To monitor propafenone levels in the patient&#44; concentration of drug was measured at 3&#46;5 h post administration&#44; obtaining 11&#46;7 ng&#47;mL &#40;0&#46;0117 &#181;g&#47;mL&#41; of propafenone in plasma&#46; This result coincided with the dose administered&#59; however&#44; it differed from results reported in the literature&#44; even though the clinical response of the patient was favorable with a dose of 2&#46;5 mg&#47;kg&#47;day&#46; The patient&#180;s health improved under the constant medical care by the personnel of the Cardiological Health Care Unit&#44; and monitoring through EKG&#44; reveling a favorable evolution of the patient&#46; </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Limitations of case</span></p><p class="elsevierStylePara">During clinical surveillance&#44; the patient was maintained in control of the disease that was enough for physician to decide not to ask for therapeutic monitoring of propafenone levels&#44; but if this would be indicated&#44; a strong relationship between levels and therapeutic response&#46;</p><p class="elsevierStylePara">We concluded that chronic use of propafenone is indicated for patients with SVT secondary to WPW syndrome&#46;</p><p class="elsevierStylePara">As a temporal solution the use of magistral formulations in pediatric population has to be evaluated in terms of safety and efficacy but in terms of relationship between risk-benefit during prolonged use of propafenone&#44; overall when such relationship will be compared with a spontaneous favorable evolution in the group of patients younger than one year of age diagnosed of WPW syndrome&#46; </p><p class="elsevierStylePara">This study was supported partially by Abbott Laboratories&#44; specifically for its presentation in the 35<span class="elsevierStyleSup">th</span> Annual Meeting of American College of Clinical Pharmacology&#44; held in Cambridge &#40;MA&#41;&#44; 2006 September 16-19&#46;</p><p class="elsevierStylePara">There is not conflict of interest&#46; </p><hr></hr><p class="elsevierStylePara"> &#42;<span class="elsevierStyleItalic">Corresponding author&#58;</span> Carmen Flores P&#233;rez&#46;<br></br> Avenida Im&#225;n No&#46;1 3er piso&#44; Colonia Cuicuilco&#44; 04530 M&#233;xico&#44; D&#46;F&#46; M&#233;xico&#46;<br></br> Telephone &#38; Fax&#58; &#40;55&#41; 5255-1084-3883&#46;<br></br> Correo electr&#243;nico&#58; <a href="mailto&#58;cfp3575&#64;yahool&#46;com&#46;mx" class="elsevierStyleCrossRefs">cfp3575&#64;yahool&#46;com&#46;mx</a></p><p class="elsevierStylePara">Received&#58; July 4&#44; 2007&#59;<br></br> accepted&#58; December 15&#44; 2008&#46;</p>"
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