Amoxycillin Clavulanic Acid Induced Hepatotoxicity.

Drug-related hepatotoxicity is a serious health problem, with broad implications for patients, healthcare providers, the pharmaceutical industry and governmental regulatory agencies. Herein we report a rare case of amoxycillinclavulanic acid combination induced liver injury of cholestatic pattern in 40 years old, well educated male patient. Patient gave history that though other drugs were given to him by his physician for fever with chills & rigors, malaise, bodyache, except amoxycillin-clavulanic acid combination all other drugs were well tolerated previously by the patient, without appearance of jaundice. So jaundice in this patient was most probably due to amoxycillinclavulanic acid combination. Though severe liver injury is rare, proper history should be taken while prescribing amoxycillin-clavulanic acid combination. Attention must be paid to potential side-effects of the drugs and close follow-up with patients is a medical necessity to evaluate adverse reactions, especially in case of amoxycillinclavulanic acid combination.

Falla hepática fulminante por virus Epstein Barr: rol de los corticoides: caso clínico / Epstein Barr virus and acute liver failure: role of steroids: clinical case

La falla hepática fulminante (FHF) debida a Virus Epstein Barr (VEB) es poco frecuente en inmunocompetentes. La utilidad de los esteroides en este cuadro no ha sido definida y permanece muy controversial. Objetivo: Reportar el caso de una paciente con mononucleosis infecciosa por VEB que presenta FHF y es tratada con corticoides. Caso clínico: Escolar con cuadro de 2 sem de síntomas respiratorios altos, fiebre, adenopatías, con ictericia y orina oscura. Bilirrubina total: 9; B. Directa: 6,3; Fosfatasas Alcalinas: 523; GOT: 7.527; GPT: 6.537; Protrombina (PT): 17 por ciento INR: 4,7; Amonio 510 y glicemia 33. Ecografía abdominal hígado normal y esplenomegalia. Monotest Positivo. Se transfirió a centro de trasplante hepático (TH). Laboratorio de ingreso PT 21 por ciento; bilirrubina en 9,8; GOT 2717; GPT 3716 y amonio 177. EEG con enlentecimiento difuso compatible con encefalopatía grado 1. IgM VEB positiva, descartándose otras etiologías. Se activó para TH por FHF y mientras se administró Metilprednisolona por 5 días. Evolucionó con normalización de las pruebas hepáticas y mejoría clínica. Conclusión: En este caso el uso de esteroides se asoció a una rápida y favorable respuesta tanto clínica como de laboratorio sin presentar efectos secundarios negativos. Al igual que en otras presentaciones de infección grave por VEB, debiera considerarse el uso de esteroides en FHF por VEB.

Acute liver failure (ALF) due to Epstein Barr Virus (EBV) is rare in immunocompetent patients. The role of steroids in this case is not well defined and remains controversial. Case report: 7 years old female presenting with unspecific respiratory symptoms for 2 weeks, fever, lymphadenopathy, jaundice and dark brown urine. Total bilirubin: 9 and direct: 6.3, alkaline phosphatases: 523; AST: 7.527, ALT: 6.537; Prothrombin (PT): 17 percent, INR: 4.7; ammonium 510 and glucose 33. Abdominal ultrasound: normal liver and splenomegaly. Monotest Positive. She was transferred to a liver transplant centre (LT). Lab results at admission: PT 21 percent, bilirubin 9.8, AST 2717, ALT 3.716 and ammonium 177. EEG with diffuse and slowing conductivity consistent with encephalopathy. Positive IgM EBV, other aetiologies were ruled out. She was activated for LT due to ALF and while in waiting list methylprednisolone was administered for 5 days. She evolved with normalization of liver tests and clinical improvement. Conclusion: In this case the use of steroids was associated with a rapid and favourable clinical and laboratory response without negative side effects. As in other presentations of serious infection by EBV, should consider the use of steroids in ALF due to EBV.

Erythema multiforme under the treatment with amoxicillin/clavulanate: a case report and review of the literature

To report a case of Erythema Multiforme [EM] in a boy who was treated with oral Amoxicillin/Clavulanate for upper respiratory infection. A 14-years-old boy with upper respiratory infection was treated with amoxicillin/calvulanate 625 milligram every eight hours for a week for his symptoms. Four days later, he developed erythematous rash all over the body plus genital lesion, and mouth ulceration. The skin biopsies confirmed Erythema Multiforme [EM]. The drug was immediately stopped and he was given a corticosteroid orally and supportive therapy for his symptoms. Within a few days, his skin and mouth lesions were dramatically improved and he was discharged on prednisone tapering dose for additional ten days. Erythema multiforme [EM] is an acute mucocutaneous hypersensitivity reaction that occurs in response to certain types of drugs, chemicals or infections. The severity of the skin lesions is variable. A Medline search from 1984 to October 2007 revealed only five cases of amoxicillin/clavulanate induced EM. The Naranjo algorithm score was 4 for EM in our patient, representing a possible relationship of amoxicillin/clavulanate treatment. We described the case of a 14-year-old boy who developed EM while on amoxicillin/clavulanate. The patient completely recovered after stopping the offending drug and treated with oral prednisone and supportive therapy

Eficácia e segurança de Sultamicilina (Ampicilina/Sulbactam) e Amoxacilina/Clavulanato no tratamento das infecções de via aéreas superiores em adultos: um estudo multicêntrico, aberto e randomizado / Efficacy and safety of Sultamicillin (Ampicillin/Sulbactan) and Amoxicillin/Clavulanic Acid in the treatment of upper respiratory tract infections in adults: an open-label, multicentric, randomized trial

As IVAS em crianças e adultos são os motivos mais freqüentes de consulta médica e os que mais demandam o uso de antibióticos. A crescente resistência bacteriana causada pela produção das beta-lactamases constitui um dos mais sérios problemas atuais. A Sultamicilina é uma pró-droga dupla da ampicilina e do sulbactam, um potente inibidor de beta-lactamases que pode fazer frente a estas dificuldades. OBJETIVO: avaliar a eficácia, segurança e tolerabilidade da Ampicilina/Sulbactan comparada à Amoxacilina/Acido Clavulânico no tratamento de IVAS, em adultos. METODOLOGIA: 102 pacientes com diagnóstico de IVAS foram randomizados em dois grupos recebendo Ampicilina/Sulbactan ou Amoxacilina/Clavulanato por 10 dias. Foram avaliados 10 e 30 dias após para análise da resposta terapêutica. RESULTADOS: Não houve diferença entre os grupos com relação à proporção de pacientes curados ao final do tratamento (visita 2) ou do estudo (visita 3). No grupo que recebeu Amoxacilina/Clavulanato, as proporções de cura foram de 61.7 por cento e 93.2 por cento nas visitas 2 e 3, comparadas a 64.4 por cento e 97.4 por cento, respectivamente, no grupo que recebeu Ampicilina/Sulbactan. A proporção de pacientes que experimentou pelo menos um evento adverso foi semelhante nos dois grupos (p = 0.940). A diarréia foi significativamente mais freqüente no grupo Amoxacilina-Clavulanato (70.6 por cento) do que no grupo Ampicilina/Sulbactan (29.4 por cento), (p=0.0164). CONCLUSÕES: A Ampicilina/Sulbactan é tão segura e eficaz quanto a Amoxacilina/Clavulanato no tratamento empírico de IVAS em adultos. A ocorrência significativamente menor de quadros de diarréia no grupo recebendo Ampicilina/Sulbactan necessita confirmação em estudos posteriores.

Upper respiratory tract infections are the most common causes of medical visits in children and adults, demanding massive use of antibiotics. Bacterial resistance caused by beta-lactamase is one of the most serious problems in this matter. Sultamicillin, a double pro-drug of Ampicillin/Sulbactan, is a potent beta-lactamase inhibitor which can face this challenge. AIM: evaluate efficacy, safety and tolerability of Ampicillin/Sulbactan compared to Amoxicillin/Clavulanate in upper respiratory tract infections in adults. METHODS: 102 patients were enrolled and randomized to receive Ampicillin/Sulbactan or Amoxicillin/Clavulanate during 10 days. They were evaluated 10 and 30 days after treatment to learn about the therapeutic response. RESULTS: There were no differences between the two groups respecting cure at the end of treatment (visit 2) or at the end of the study (visit 3). Cure ratio was 61.7 percent and 93.2 percent (visits 2 and 3) in the Amoxicillin/Clavulanate group compared to 64.4 percent and 97.4 percent, respectively, in Ampicillin/Sulbactan group. The adverse events ratio for the two groups was the same (p=0.940). The number of patients with diarrhea was greater in the group of patients receiving Amoxicillin/Clavulanate (70.6 percent) than in the group receiving Ampicillin/Sulbactan (29.4 percent) (p=0.0164). CONCLUSIONS: Ampicillin/Sulbactan is as safe and efficient as Amoxicillin/Clavulanate in the empiric treatment of upper respiratory infections in adults. The low occurrence of diarrhea in the group receiving Ampicillin/Sulbactan needs confirmation in other studies.

Imipenem therapy for septicemic melioidosis in a child with penicillin and cephalosporin adverse reaction.

The recommended treatment for severe melioidosis is ceftazidime or a combination of ceftazidime and trimethoprim-sulfamethoxazole (TMP/SMX). Amoxicillin-clavulanate has been shown to be an effective alternative therapy. In patient who is allergic to penicillin and cephalosporin, imipenem an alternative drug may be used. We described a 10 year-old boy who was diagnosed as septicemic melioidosis and type 1 diabetes mellitus. He developed fever and rash while being given ceftazidime and TMP/SMX. The fever recurred when amoxicillin-clavulanate was administered orally. He was successfully treated with imipenem.

Estudio ORACLE: protocolo y estado actual de la investigación en la Argentina / ORACLE study: protocol and present status of the investigation in Argentine

ORACLE es una investigación aleatorizada factorial pragmática multicéntrica, dirigida desde la Universidad de Leicester (Reino Unido), cuyo objetivo es verificar el rol de la antibióticoterapia (eritromicina y/o augmentina y/o placebo) en la amenaza de parto prematuro (APP), con o sin rotura prematura de membranas (RPM). Los puntos finales principales son mortalidad perinatal y morbilidad neonatal severa. El tamaño muestral propuesto es de 10.000 casos. Participan 164 maternidades de 16 países y se llevan incluidos 7.364 pacientes. Argentina, que inició su gestión en agosto de 1997, a marzo de 1999 lleva incluidos 762 pacientes, reclutados entre las 9 maternidades participantes, sitas en Buenos Aires, provincia de Buenos Aires y Salta. Dos de ellas, figuran 2º y 3º en la lista de hospitales con mayor índice de reclutamiento en el mundo. El 88 por ciento de las ingresadas presentó APP y el 12 por ciento, RPM. Ambas situaciones se combinaron en el 8 por ciento de ellas. La mediana de la edad gestacional al ingreso es 32 semanas (cuartilos: 29 y 34). El 82,6 por ciento ya finalizó su participación y sólo hay un 2 por ciento de pérdidas de seguimiento. El 58 por ciento de los nacimientos ocurrió al término. La mediana de peso al nacer es 2.870 g (cuartilos 2.250 y 3.250). El 27 por ciento requirió UTI y la mortalidad perinatal es 3,6 por ciento. No se han registrado efectos adversos fetoneonatales atribuibles a las medicaciones del estudio. Los efectos adversos maternos suman 14 casos y han sido los habituales ante el consumo de antibióticos.