Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil / Efeitos adversos das drogas (minociclina, ofloxacina e clofazimina) utilizadas no esquema alternativo para pacientes com hanseníase multibacilar, em unidade de referência, Manaus, Amazonas, Brasil

BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies ...

FUNDAMENTOS: Após introdução do esquema poliquimioterápico padrão, houve declínio nos coeficientes de prevalência e detecção de casos novos; entretanto, os registros de resistência medicamentosa e recidivas representam ameaça para o controle da hanseníase. Dessa forma, a proposição de novos esquemas alternativos e a necessidade de monitorar efeitos adversos são importantes para evitar o abandono do tratamento. OBJETIVO: Descrever efeitos adversos do esquema alternativo contendo clofazimina, ofloxacina e minociclina em pacientes com hanseníase multibacilar. MÉTODOS: Estudo prospectivo, descritivo e observacional de casos multibacilares, incluindo recidivas ou intolerância à poliquimioterapia padrão, realizado na Fundação Alfredo da Matta, Manaus, Amazonas, de abril de 2010 a janeiro de 2012. Os indivíduos receberam a terapia composta de doses diárias auto-administradas de 100mg de minociclina, 400mg de ofloxacina e 50mg de clofazimina e mensais supervisionadas de 300mg de clofazimina por seis meses, seguidas de 18 meses de doses diárias de ofloxacina 400mg, clofazimina 50 mg e supervisionadas mensais de clofazimina 300mg. Resultados: 21 pacientes foram incluídos. Efeitos adversos leves e transitórios foram observados em 33,3% dos pacientes; 45,9% foram atribuídos à ofloxacina, como dor abdominal, náuseas, vômitos, cefaléia e insônia; 21,6% foram associados à clofazimina, com relatos e observação em 100% dos pacientes de hiperpigmentação cutânea. O tempo médio de desenvolvimento das reações adversas a partir do início do esquema foi de 15,2 dias. ...

Severe shoulder tendinopathy associated with levofloxacin

Fluoroquinolone (FQ)-associated tendinopathy and myopathy are uncommon but well recognized complications of the use of this class of antibacterial agents. The case of a 63-year-old previously asymptomatic female patient who developed severe left shoulder tendinopathy after surreptitiously doubling the prescribed dose of levofloxacin for the treatment of community-acquired pneumonia is reported here. Surgical stabilization with suture anchors and subacromial decompression were needed.

Preditores dos desfechos do tratamento da tuberculose / Predictors of tuberculosis treatment outcomes

OBJETIVO: Analisar os desfechos do tratamento da tuberculose e seus preditores. MÉTODOS: Estudo longitudinal de coorte de pacientes com tuberculose tratados entre 2004 e 2006 no Instituto de Pesquisa Evandro Chagas, na cidade do Rio de Janeiro. As razões de risco ajustadas (RRa) dos preditores foram estimadas. RESULTADOS: Foram incluídos 311 pacientes. As taxas de cura, de abandono, de mortalidade e de falha terapêutica foram, respectivamente, 72 por cento, 19 por cento, 6 por cento e 2 por cento. A troca de regime terapêutico por eventos adversos foi necessária em 8 por cento. O alcoolismo (RRa, 0,30), uso do regime estreptomicina+etambutol+ofloxacina (SEO; RRa, 0,32), infecção por HIV sem tratamento antirretroviral (TARV; RRa, 0,36) e o uso do regime rifampicina+isoniazida+pirazinamida+etambutol (RRa, 0,58) reduziram a probabilidade de cura. A faixa etária mais jovem (RRa, 3,84) e o alcoolismo (RRa, 1,76) aumentaram a probabilidade do abandono. Não foi possível determinar as RRa para os demais desfechos devido a suas baixas prevalências. Entretanto, medidas do risco relativo (RR) identificaram os seguintes potenciais preditores do óbito: uso de esquema SEO (RR, 11,43), infecção pelo HIV sem TARV (RR, 9,64), forma clínica disseminada (RR, 9,09), ausência de confirmação bacteriológica (RR, 4,00), diabetes mellitus (RR, 3,94) e comportamento homo/bissexual (RR, 2,97). A baixa renda (RR, 11,70) foi potencial preditor para falha terapêutica, ao passo que infecção pelo HIV com uso de TARV (RR, 2,46) e forma clínica disseminada (RR, 3,57) foram potenciais preditores para troca do esquema por evento adverso. CONCLUSÕES: O esquema SEO deve ser utilizado transitoriamente quando possível. Os dados confirmam a importância de TARV e sugerem a necessidade de seu início precoce.

OBJECTIVE: To analyze tuberculosis treatment outcomes and their predictors. METHODS: This was a retrospective longitudinal cohort study involving tuberculosis patients treated between 2004 and 2006 at the Instituto de Pesquisa Evandro Chagas, in the city of Rio de Janeiro. We estimated adjusted risk ratios (ARRs) for the predictors of treatment outcomes. RESULTS: Among 311 patients evaluated, the rates of cure, treatment abandonment, treatment failure, and mortality were 72 percent, 19 percent, 2 percent, and 6 percent, respectively. Changes in the treatment regimen due to adverse events occurred in 8 percent. The factors found to reduce the probability of cure were alcoholism (ARR, 0.30), use of the streptomycin+ethambutol+ofloxacin (SEO) regimen (ARR, 0.32), HIV infection without the use of antiretroviral therapy (ART; ARR, 0.36), and use of the rifampin+isoniazid+pyrazinamide+ethambutol regimen (ARR, 0.58). Being younger and being alcoholic both increased the probability of abandonment (ARR, 3.84 and 1.76, respectively). It was impossible to determine the ARR for the remaining outcomes due to their low prevalence. However, using the relative risk (RR), we identified the following potential predictors of mortality: use of the SEO regimen (RR, 11.43); HIV infection without ART (RR, 9.64); disseminated tuberculosis (RR, 9.09); lack of bacteriological confirmation (RR, 4.00); diabetes mellitus (RR, 3.94); and homosexual/bisexual behavior (RR, 2.97). Low income was a potential predictor of treatment failure (RR, 11.70), whereas disseminated tuberculosis and HIV infection with ART were potential predictors of changes in the regimen due to adverse events (RR, 3.57 and 2.46, respectively). CONCLUSIONS: The SEO regimen should not be used for extended periods. The data confirm the importance of ART and suggest the need to use it early.

Hypersensitivity Reaction to Ofloxacin.

The quinolones are generally well tolerated. The adverse reactions of quinolones include gastrointestinal symptoms, which are the most frequent, neuropsychiatric symptoms, hematologic abnormalities and less frequently, hypersensitivity skin reactions. Herein we report a case of 13 years old boy, who was suffering from upper respiratory tract infection and was treated with ofloxacin by a private practitioner and developed hypersensitivity reaction, one hour after taking ofloxacin tablet. Hospitalization and treatment of patient was carried out. Since hypersensitivity reaction to ofloxacin is rare, proper history of drug reactions should be taken while prescribing ofloxacin. Attention must be paid to potential side-effects of the drug while prescribing any medication, and close follow-up with patients is a medical necessity to evaluate for these adverse reactions, especially with quinolones.

Retrospective Comparison of Levofloxacin and Moxifloxacin on Multidrug-Resistant Tuberculosis Treatment Outcomes

BACKGROUND/AIMS: To compare the effect of levofloxacin and moxifloxacin on treatment outcomes among patients with multidrug-resistant tuberculosis (MDR-TB). METHODS: A retrospective analysis of 171 patients with MDR-TB receiving either levofloxacin or moxifloxacin was performed. Treatment responses were categorized into treatment success (cured and treatment completed) or adverse treatment outcome (death, failure, and relapsed). RESULTS: The median age of the patients was 42.0 years. Approximately 56% of the patients were male. Seventeen patients had extensively drug-resistant tuberculosis, and 20 had a surgical resection. A total of 123 patients (71.9%) received levofloxacin for a median 594 days, and 48 patients (28.1%) received moxifloxacin for a median 673 days. Other baseline demographic, clinical, and radiographic characteristics were similar between the two groups. The moxifloxacin group had a significantly higher number of resistant drugs (p < 0.001) and a higher incidence of resistance to ofloxacin (p = 0.005) in the drug sensitivity test. The treatment success rate was 78.9% in the levofloxacin group and 83.3% in the moxifloxacin group (p = 0.42). Adverse reactions occurred at similar rates in the groups (p = 0.44). Patients in the moxifloxacin group were not more likely to have treatment success than those in the levofloxacin group (adjusted odds ratio, 0.76; 95% confidence interval, 0.24 to 2.43; p = 0.65). CONCLUSIONS: Both levofloxacin and moxifloxacin showed equivalent efficacy for treating MDR-TB.

Levofloxacin-Induced Achilles Tendinitis in a Young Adult in the Absence of Predisposing Conditions

Fluoroquinolones (FQs) represent a major class of antimicrobials that have a high potential as therapeutic agents. Although FQs are generally safe for the use as antimicrobials, they may induce tendinopathic complications such as tendinitis and tendon rupture. A number of factors have been suggested to further predispose a patient to such injuries. Hitherto, a few published cases on tendon disorders have implicated levofloxacin, a more recently introduced FQ. Here, we report a patient with levofloxacin-induced Achilles tendinitis, who exhibited no known predisposing factors. A 20-year-old man without any history of disease or medication presented with community-acquired pneumonia. Levofloxacin was administered and 3 days later, he complained of pain in the left Achilles tendon and revealed redness and swelling in the area. On suspecting Achilles tendinitis, levofloxacin treatment was discontinued, and the tendinitis subsequently improved. To our knowledge, this is the first case report on FQ-induced Achilles tendinitis in Korea.

Typhoid Fever; clinical experience with levofloxacin, its efficacy and safety

To find out the efficacy and safety of Levofloxacin in patients suffering from typhoid fever. Non-comparative and prospective study. Medical Units of Allied and DHQ Hospital [PMC] Faisalabad. From May 2002 to July 2004. All suspected febrile patients were examined and provisionally diagnosed to have typhoid fever were admitted for the purpose of study till they were satisfactorily discharged. This clinical study was conducted on 70 patients of Enteric Fever. Fifty-two patients were male and 18 were female. The mean age for male patients in the study sample was 37.58 +/- 8.13 while the mean age of females was 21.92 +/- 4.73 years. Fever as a symptom was present in all 70 [100%] of the patients. Anorexia was there in 61 [85.5%] patients and abdominal pain in 49 [70%] patients. Twenty-seven [38.5%] patients had constipation along with other features. Diarrhea was present in 6 [8.5%] patients. Relative bradycardia was present in 20 [28.5%] patients. Hepa tomegaly was there in 31[44.3%] and Splenomegaly in 24 [34.3%]. Elevated liver enzymes were found in 29 [41.4%] of the patients and blood cultures positive for Salmonella typhi was seen in 19 [27.1%] patients. Widal test was positive at dilution of 1:160 in almost all of the cases and at 1:320 dilution in 18% of cases in current study. The success rate of Levofloxacin in our study was 100% in the form of settlement of fever and other symptoms and signs. The side effects were seen in 17 [24.2%] patients. In conclusion levofloxacin is effective in treatment of typhoid fever and its use in this indication is safe

Open study on efficacy and safety of levofloxacin in treatment of uncomplicated typhoid fever.

The main objective of this study was to determine the clinical efficacy and safety of levofloxacin in an open setting for typhoid fever cases. Patients with clinical signs and symptoms of typhoid fever without previous antimicrobial treatment admitted to affiliated hospitals of the Faculty of Medicine, University Indonesia were included in this study. Adults, 18 years or above, were screened for any serious underlying conditions, pregnancy or possible complications of typhoid fever before final enrollment. Fifty-three subjects were screened, 48 were enrolled. The final diagnosis of enteric fever was made by positive blood culture, polymerase chain reaction or serology, was obtained in 31 cases, in whom one had a concomitant sinus infection and had to be excluded. Thirty patients (11 males, 19 females) aged between 18-58 years (mean 31.7 years) with a history of fever between 1 and 10 days (mean 6.1 days) showed excellent clinical response, becoming afebrile at an average of 2.43 days (range 1-5 days). Adverse effects noted were nausea in 4 patients, vomiting in one and meteorism in another one, which were all difficult to distinguish from the enteric infection. A pruritic rash occurring in two patients may be related to levofloxacin, and insomnia in another patient may be related. Microbiological clearance was obtained both immediately after treatment and at one month. No carrier states were detected in the cases positive for Salmonella typhi or paratyphi. None of the treated typhoid fever cases experienced a clinical relapse. In this open study of levofloxacin 500 mg/day for one week in treatment of uncomplicated typhoid fever, a 100% clinical efficacy was obtained in 30 patients with minimal adverse reactions warranting more intensive studies for this new indication of an old but well known disease in the developing world.

Ofloxacin induced arthropathy in patients with multi-drug resistance tuberculosis.

Some of the 4-fluroquinolones have been reported to induce arthropathy, but so far there are no case reports of arthropathy due to ofloxacin. Two cases of ofloxacin induced arthropathy in multi-drug resistance (MDR) tuberculosis are reported and possible drug interaction with other anti-tubercular drugs is discussed.

Quinolone induced arthropathy in adolescents and adults

To ascertain the incidence, clinical pattern and outcome of arthropathy in adolescents and adults induced by different quinolones. Cases of enteric fever treated with different quinolones having no previous history of joint disorders who developed arthropathy and improved well with conservative treatment were labelled as quinolone induced arthropathy. In-patients of Rajshahi and Khulna Medical College Hospitals and private clinics of the authors. Four hundred and three cases of enteric fever were treated with various quinolones during the period January 1995 to June 1999. Main outcome measures: Clinical characteristics, incidence, relation with quinolones used and outcome of quinolone induced arthropathy. The age of the 403 [males 260 and females 143] patient ranged from 13-60 years. They were treated with either ciprofloxacin, pefloxacin or ofloxacin. Out of them 31 [7.7%] patients developed arthropathy. It was highest with pefloxacin [12.5%]. The arthropathy was maximum [11.8%] in the age group of 11-20 years. Patterns of arthropathy were oligoarthropathy [23], polyarthropathy [7] and monoarthropathy [1]. Although quinolones use is not advocated in children for development of arthropathy, it also occurs in adolescents and adults in considerable number of cases. It improves well with conservative treatment without residual effect

Comparaçäo entre a levofloxacina oral e a associaçäo de amoxicilina e clavulanato de potássio no tratamento da sinusite bacteriana aguda em adultos / A comparison of oral levofloxacin and amoxicillin clavulanate for the treatment of acute bacterial sinusitis in adults

Os autores apresentam um estudo multicêntrico, aberto, randomizado para comparar a eficácia e tolerabilidade da Levofloxacina oral à associação de Amoxicilina e Clavulanato de potássio no tratamento de sinusite bacteriana aguda em adultos. A Levofloxacina foi administrada na dose de 500 mg 1 vez ao dia, enquanto a associação Amoxicilina (500mg)/Clavulanato de potássio (125 mg) foi administrada 3 vezes ao dia, ambos tratamentos com duração de 14 dias. Foram avaliados os sintomas dor facial, rinorréia purulenta e obstrução nasal e também os sinais hiperemia, edema, secreção purulenta e dor a palpação dos seios paranasais. Os pacientes foram avaliados na admissão, com 3 a 6 dias de tratamento, 2 a 5 dias pós terapia e com 28 a 32 dias após o término da terapia. Foram classificados de acordo com a eficácia do tratamento em curados, melhorados, com falha terapêutica ou incapazes de serem avaliados. Foram também submetidos a questionários para verificação da aceitação da medicação. Ao fim do estudo, os autores classificaram a eficácia e a tolerabilidade como boas em ambos os grupos de medicamentos, não havendo diferença estatisticamente significante entre os mesmos. Concluindo, a Levofloxacina oral mostrou-se tão eficaz e com boa tolerabilidade quanto a associação Amoxicilina/Clavulanato de potássio para o tratamento da sinusite bacteriana aguda em adultos.

Estudio de eficacia y seguridad de ofloxacina en diversas infecciones bacterianas / Study of ofloxacin efficacy and safe in diversity

Se estudiarón 64 pacientes infectados con rango de edad entre 16 y 84 años, a quienes se les administró ofloxacina. Las enfermedades incluídas en el estudio fuerón: infección de partes blandas 41,93 por ciento, infección del tracto respiratorio inferior 26,8 por ciento, infecciones del tracto urinario 24,2 por ciento, y otras infecciones (sepsis, meningitis bacteriana, complicación post-parto y politraumatismo) 6,4 por ciento. De acuerdo al grado de severidad la distribución fue la siguiente: leves: 3,23 por ciento, moderadas: 51,61 por ciento y severas: 41,94 por ciento. El tratamiento con ofloxacina se administró en dosis promedio de 800 mg/día durante 3-17 días (promedio=9,75+3,37). La evolución clínica fue curación en el 83,87 por ciento, mejoría 12,90 por ciento (curación + mejoría = 96,7 por ciento), no determinada 3,22 por ciento y fracaso 0 por ciento. La evaluación de la eficacia bacteriológica mostró erradicación 70 por ciento, erradicación/superinfección 12 por ciento, persistencia 2 por ciento, resistencia 0 por ciento y no determinado 16 por ciento. La evaluación global del tratamiento fue clasificada como excelente en el 67,24 por ciento de los pacientes, buena 27,59 por ciento (excelente +buena =94,8 por ciento), regular 5,17 por ciento. Ningún paciente fue considerado con evolución inadecuada. En cuanto a la toxicidad de la droga, se registraron reacciones adversas: ardor local, nauseas, mareos, sudoración, acidez, insomnio y rash. Estas fueron clasificadas según su severidad en leve (2) moderada (2) y severa (1) este último caso ameritó la suspensión de la droga. En conclusión, ofloxacina puede considerarse eficaz y segura para el tratamiento de infecciones bacterinas

Estudo comparativo entre lomefloxacina e ofloxacina no tratamento da prostatite bacteriana crônica / Clinical trial comparing lomefloxacin and ofloxacin in the treatment of chronic bacterial prostatitis

Foram tratados 33 pacientes com prostatite bacteriana crônica, sintomáticos, diagnosticados pelo método de Meares-Stamey, com lomefloxacina 400 mg, uma vez ao dia, ou ofloxacina 200 mg, duas vezes ao dia, num estudo randomizado, por um período de 42 dias. Todos os microorganismos eram sensíveis a ambas as drogas. Os pacientes foram seguidos por seis meses com exames bacteriológicos de urina e líquido prostático pelo método descrito. Após seis meses a taxa de cura foi de 66,6 por cento para lomefloxacina e 60 por cento para ofloxacina. Nenhum paciente com infecçäo causada por P. aeruginosa foi curado e sem computar estes pacientes a taxa de cura seria 70,5 por cento e 64 por cento, respectivamente. Os efeitos colaterais observados foram em pequeno número e de pequena intensidade, em nenhuma ocasiäo obrigando à suspensäo do tratamento. Ambas as fluoroquinolonas se mostraram eficientes no tratamento desta difícil infecçäo bacteriana. A lomefloxacina, que pode ser administrada em dose única, provavelmente é mais prática para o paciente e resulta em melhor aderência a este longo tratamento