Lyflox

Tratamiento

Los comprimidos recubiertos con película de lyflox (lomefloxacina HCl) están indicados para el tratamiento de adultos con infecciones leves a moderadas causadas por cepas susceptibles de los microorganismos designados en las condiciones que se enumeran a continuación: (Ver DOSIS Y ADMINISTRACIÓN para recomendaciones específicas de dosificación.)

Tracto respiratorio inferior

Exacerbación bacteriana aguda de la bronquitis crónica causada por Haemophilus influenzae o Moraxella catarrhalis.¹

NOTA: Lyflox NO ESTÁ INDICADO PARA EL TRATAMIENTO EMPIRICO DE LA EXACERBACIÓN BACTERIAL AGUDA DE BRONQUÍTICA CRÓNICA CUANDO ES PROBABLE QUE S NEUMONIAE ES UN PATÓGENO CAUSATIVO. S EXPOSICIONES NEUMONIAAS EN VITRO RESISTENCIA A LOMEFLOXACINA, Y LA SEGURIDAD Y EFICACIA DE LA LOMEFLOXACINA EN EL TRATAMIENTO DE PACIENTES CON LA EXACERBACIÓN BACTERIAL ADUTA DE LA BRONCHITIS CRÓNICA CAUSADA S NEUMONIAE NO HAN SIDO DEMOSTRADOS. SI LA LOMEFLOXACINA DEBE SER PRESCRIBIDA PARA GRAM – STAIN– TERAPIA EMPIRICA GUIDA DE LA EXACERBACIÓN BACTERIAL AGUDA DE BRONQUÍTICA CRÓNICA, DEBE SER UTILIZADO SOLO SI LA GRANJA DE ESPUTUM DEJA DEMOSTRAR UNA CALIDAD ADECUADA DE ESPECÍMENES ( > 25 PMN / LPF) Y HAY AMBOS UNA PREDOMINANCIA DE MICROORGANISMOS NEGATIVOS DE GRAMO Y NO UNA PREDOMINACIÓN DE MICROORGANISMOS POSITIVOS DE GRAMO

Tracto urinario

Infecciones del tracto urinario sin complicaciones (cistitis) causada por Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis o Staphylococcus saprophyticus. (Ver DOSIS Y ADMINISTRACIÓN y Estudios clínicos—Cistitis sin complicaciones.)

Infecciones complicadas del tracto urinario causado por Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter diversus,¹ o Enterobacter cloacae.¹

NOTA: En ensayos clínicos con pacientes que experimentaron infecciones complicadas del tracto urinario (ITU) debido a P aeruginosa, 12 de 16 pacientes tuvieron el microorganismo erradicado de la orina después de la terapia con lomefloxacina. Ninguno de los pacientes tenía bacteriemia concomitante. Los niveles séricos de lomefloxacina no exceden de manera confiable el MIC de los aislados de Pseudomonas. LA SEGURIDAD Y EFICACIA DE LA LOMEFLOXACINA EN TRATAR PACIENTES CON PSEUDOMONAS BACTEREMIA NO SE HAN ESTABLECIDO

Se deben realizar pruebas apropiadas de cultivo y susceptibilidad antes del tratamiento antimicrobiano para aislar e identificar microorganismos que causan infección y determinar su susceptibilidad a la lomefloxacina. En pacientes con ITU, la terapia con tabletas recubiertas con película de Lyflox puede iniciarse antes de que se conozcan los resultados de estas pruebas; Una vez que estos resultados estén disponibles, se debe continuar con la terapia adecuada. En pacientes con una exacerbación bacteriana aguda de la bronquitis crónica, la terapia no debe iniciarse empíricamente con lomefloxacina cuando existe la probabilidad de que el patógeno causal sea S pneumoniae.

La producción de beta-lactamasa no debería tener efecto sobre la actividad de la lomefloxacina.

Prevención / profilaxis

Lyflox está indicado preoperativamente para la prevención de infecciones en las siguientes situaciones:

• Biopsia de próstata transrectal: para reducir la incidencia de infección del tracto urinario, en los períodos postoperatorios tempranos y tardíos (3 a 5 días y 3 a 4 semanas de cirugía).
• Procedimientos quirúrgicos transuretrales: para reducir la incidencia de infección del tracto urinario en el período postoperatorio temprano (posturgería de 3 a 5 días).

No se ha establecido la eficacia para disminuir la incidencia de infecciones distintas de la infección del tracto urinario. Lyflox, como todos los medicamentos para la profilaxis de los procedimientos quirúrgicos transuretrales, generalmente no debe usarse en procedimientos urológicos menores para los cuales no se indica la profilaxis (p. Ej., Cistoscopia simple o pielografía retrógrada). (Ver DOSIS Y ADMINISTRACIÓN.)

Para reducir el desarrollo de bacterias resistentes a los medicamentos y mantener la efectividad de Lyflox y otros medicamentos antibacterianos, Lyflox debe usarse solo para tratar o prevenir infecciones que se prueban o se sospecha que son causadas por bacterias susceptibles. Cuando hay información disponible sobre cultivo y susceptibilidad, se deben considerar al seleccionar o modificar la terapia antibacteriana. En ausencia de dichos datos, la epidemiología local y los patrones de susceptibilidad pueden contribuir a la selección empírica de la terapia.

REFERENCIAS

¹Aunque el tratamiento de infecciones debido a este microorganismo en este sistema de órganos demostró un resultado general clínicamente aceptable, se estudió la eficacia en menos de 10 infecciones.

Lyflox (lomefloxacina HCl) puede tomarse sin tener en cuenta las comidas. El sucralfato y los antiácidos que contienen magnesio o aluminio, o Videx® (didanosina), tabletas masticables / tamponadas o el polvo pediátrico para solución oral no deben tomarse dentro de las 4 horas antes o 2 horas después de tomar lomefloxacina. El riesgo de reacción a la luz solar UVA puede reducirse tomando Lyflox al menos 12 horas antes de la exposición al sol (por ejemplo, por la noche). (Ver FARMACOLOGÍA CLÍNICA.)

Ver INDICACIONES Y USO para información sobre patógenos apropiados y poblaciones de pacientes.

Tratamiento

Pacientes con función renal normal

La dosis diaria recomendada de Lyflox se describe en el siguiente cuadro:

Pacientes de edad avanzada

No se necesita ajuste de dosis para pacientes de edad avanzada con función renal normal (ClCr ≥ 40 ml / min / 1.73 m²).

Pacientes con insuficiencia renal

La lomefloxacina se elimina principalmente por excreción renal. (Ver FARMACOLOGÍA CLÍNICA) Se recomienda modificar la dosis en pacientes con disfunción renal. En pacientes con un aclaramiento de creatinina> 10 ml / min / 1.73 m² pero <40 ml / min / 1.73 m², la dosis recomendada es una dosis de carga inicial de 400 mg seguida de dosis de mantenimiento diario de 200 mg (½ tableta) una vez al día para La duración del tratamiento. Se sugiere que se realicen determinaciones en serie de los niveles de lomefloxacina para determinar cualquier alteración necesaria en el siguiente intervalo de dosificación apropiado.

Si solo se conoce la creatinina sérica, se puede usar la siguiente fórmula para estimar el aclaramiento de creatinina.

Pacientes en diálisis

La hemodiálisis elimina solo una cantidad insignificante de lomefloxacina (3% en 4 horas). Los pacientes con hemodiálisis deben recibir una dosis de carga inicial de 400 mg seguida de dosis de mantenimiento diarias de 200 mg (½ tableta) una vez al día durante la duración del tratamiento.

Pacientes con cirrosis

La cirrosis no reduce el aclaramiento no renal de la lomefloxacina. La necesidad de una reducción de la dosis en esta población debe basarse en el grado de función renal del paciente y en las concentraciones plasmáticas. (Ver FARMACOLOGÍA CLÍNICA y DOSIS Y ADMINISTRACIÓN - Pacientes con insuficiencia renal.)

Prevención / profilaxis

La dosis recomendada de Lyflox se describe en el siguiente cuadro:

Lyflox (lomefloxacina HCl) está contraindicado en personas con antecedentes de hipersensibilidad a la lomefloxacina o cualquier miembro del grupo de agentes antimicrobianos de quinolona.

WARNINGS

MODERATE TO SEVERE PHOTOTOXIC REACTIONS HAVE OCCURRED IN PATIENTS EXPOSED TO DIRECT OR INDIRECT SUNLIGHT OR TO ARTIFICIAL ULTRAVIOLET LIGHT (eg, sunlamps) DURING OR FOLLOWING TREATMENT WITH LOMEFLOXACIN. THESE REACTIONS HAVE ALSO OCCURRED IN PATIENTS EXPOSED TO SHADED OR DIFFUSE LIGHT, INCLUDING EXPOSURE THROUGH GLASS. PATIENTS SHOULD BE ADVISED TO DISCONTINUE LOMEFLOXACIN THERAPY AT THE FIRST SIGNS OR SYMPTOMS OF A PHOTOTOXICITY REACTION SUCH AS A SENSATION OF SKIN BURNING, REDNESS, SWELLING, BLISTERS, RASH, ITCHING, OR DERMATITIS.

These phototoxic reactions have occurred with and without the use of sunscreens or sunblocks. Single doses of lomefloxacin have been associated with these types of reactions. In a few cases, recovery was prolonged for several weeks. As with some other types of phototoxicity, there is the potential for exacerbation of the reaction on re-exposure to sunlight or artificial ultraviolet light prior to complete recovery from the reaction. In rare cases, reactions have recurred up to several weeks after stopping lomefloxacin therapy.

EXPOSURE TO DIRECT OR INDIRECT SUNLIGHT (EVEN WHEN USING SUNSCREENS OR SUNBLOCKS) SHOULD BE AVOIDED WHILE TAKING LOMEFLOXACIN AND FOR SEVERAL DAYS FOLLOWING THERAPY. LOMEFLOXACIN THERAPY SHOULD BE DISCONTINUED IMMEDIATELY AT THE FIRST SIGNS OR SYMPTOMS OF PHOTOTOXICITY. RISK OF PHOTOTOXICITY MAY BE REDUCED BY TAKING LOMEFLOXACIN IN THE EVENING (See DOSAGE AND ADMINISTRATION.)

THE SAFETY AND EFFICACY OF LOMEFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS—Pediatric Use, Pregnancy and Nursing Mothers subsections.) The oral administration of multiple doses of lomefloxacin to juvenile dogs at 0.3 times and to rats at 5.4 times the recommended adult human dose based on mg/m² (0.6 and 34 times the recommended adult human dose based on mg/kg, respectively) caused arthropathy and lameness. Histopathologic examination of the weight-bearing joints of these animals revealed permanent lesions of the cartilage. Other quinolones also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in juvenile animals of various species. (See Animal Pharmacology.)

Convulsions have been reported in patients receiving lomefloxacin. Whether the convulsions were directly related to lomefloxacin administration has not yet been established. However, convulsions, increased intracranial pressure, and toxic psychoses have been reported in patients receiving other quinolones. Nevertheless, lomefloxacin has been associated with a possible increased risk of seizures compared to other quinolones. Some of these may occur with a relative absence of predisposing factors. Quinolones may also cause central nervous system (CNS) stimulation, which may lead to tremors, restlessness, lightheadedness, confusion, and hallucinations. If any of these reactions occurs in patients receiving lomefloxacin, the drug should be discontinued and appropriate measures instituted. However, until more information becomes available, lomefloxacin, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, or other factors that predispose to seizures. (See ADVERSE REACTIONS.) Psychiatric disturbances, agitation, anxiety, and sleep disorders may be more common with lomefloxacin than other products in the quinolone class.

The safety and efficacy of lomefloxacin in the treatment of acute bacterial exacerbation of chronic bronchitis due to S pneumonia have not been demonstrated. This product should not be used empirically in the treatment of acute bacterial exacerbation of chronic bronchitis when it is probable that S pneumoniae is a causative pathogen.

In clinical trials of complicated UTIs due to P aeruginosa, 12 of 16 patients had the microorganism eradicated from the urine after therapy with lomefloxacin. No patients had concomitant bacteremia. Serum levels of lomefloxacin do not reliably exceed the MIC of Pseudomonas isolates. THE SAFETY AND EFFICACY OF LOMEFLOXACIN IN TREATING PATIENTS WITH PSEUDOMONAS BACTEREMIA HAVE NOT BEEN ESTABLISHED.

Serious and occasionally fatal hypersensitivity (anaphylactoid or anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, or itching. Only a few of these patients had a history of previous hypersensitivity reactions. Serious hypersensitivity reactions have also been reported following treatment with lomefloxacin. If an allergic reaction to lomefloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment with epinephrine. Oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, including intubation, should be administered as indicated.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including lomefloxacin, and may range from mild to life-threatening in severity. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antimicrobial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C difficile colitis.

QT interval prolongation/torsades de pointes

Rare cases of torsades de pointes have been spontaneously reported during post-marketing surveillance in patients receiving quinolones, including lomefloxacin. These rare cases were associated with one or more of the following factors: age over 60, female gender, underlying cardiac disease, and/or use of multiple medications. Lomefloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.

Peripheral neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including lomefloxacin. Lomefloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Tendon effects

Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including lomefloxacin. Postmarketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Lomefloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including lomefloxacin.

PRECAUTIONS

General

Alteration of the dosage regimen is recommended for patients with impairment of renal function (ClCr < 40 mL/min/1.73 m²). (See DOSAGE AND ADMINISTRATION.)

Prescribing Lyflox in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenesis

Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 52 weeks while concurrently being administered lomefloxacin. The lomefloxacin doses used in this study caused a phototoxic response. In mice treated with both UVA and lomefloxacin concomitantly, the time to development of skin tumors was 16 weeks. In mice treated concomitantly in this model with both UVA and other quinolones, the times to development of skin tumors ranged from 28 to 52 weeks.

Ninety-two percent (92%) of the mice treated concomitantly with both UVA and lomefloxacin developed well-differentiated squamous cell carcinomas of the skin. These squamous cell carcinomas were nonmetastatic and were endophytic in character. Twothirds of these squamous cell carcinomas contained large central keratinous inclusion masses and were thought to arise from the vestigial hair follicles in these hairless animals.

In this model, mice treated with lomefloxacin alone did not develop skin or systemic tumors.

There are no data from similar models using pigmented mice and/or fully haired mice

The clinical significance of these findings to humans is unknown.

Mutagenesis

One in vitro mutagenicity test (CHO/HGPRT assay) was weakly positive at lomefloxacin concentrations ≥ 226 μ g/mL and negative at concentrations < 226 μ g/mL. Two other in vitro mutagenicity tests (chromosomal aberrations in Chinese hamster ovary cells, chromosomal aberrations in human lymphocytes) and two in vivo mouse micronucleus mutagenicity tests were all negative.

Impairment of fertility

Lomefloxacin did not affect the fertility of male and female rats at oral doses up to 8 times the recommended human dose based on mg/m² (34 times the recommended human dose based on mg/kg).

Pregnancy

Teratogenic effects - Pregnancy Category C

Reproductive function studies have been performed in rats at doses up to 8 times the recommended human dose based on mg/m² (34 times the recommended human dose based on mg/kg), and no impaired fertility or harm to the fetus was reported due to lomefloxacin. Increased incidence of fetal loss in monkeys has been observed at approximately 3 to 6 times the recommended human dose based on mg/m² (6 to 12 times the recommended human dose based on mg/kg). No teratogenicity has been observed in rats and monkeys at up to 16 times the recommended human dose exposure. In the rabbit, maternal toxicity and associated fetotoxicity, decreased placental weight, and variations of the coccygeal vertebrae occurred at doses 2 times the recommended human exposure based on mg/m². There are, however, no adequate and well-controlled studies in pregnant women. Lomefloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

It is not known whether lomefloxacin is excreted in human milk. However, it is known that other drugs of this class are excreted in human milk and that lomefloxacin is excreted in the milk of lactating rats. Because of the potential for serious adverse reactions from lomefloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

The safety and effectiveness of lomefloxacin in pediatric patients and adolescents less than 18 years of age have not been established. Lomefloxacin causes arthropathy in juvenile animals of several species. (See WARNINGS and Animal Pharmacology.)

Geriatric use

Of the total number of subjects in clinical studies of lomefloxacin, 25% were ≥ 65 years and 9% were ≥ 75 years. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY — Pharmacokinetics in the geriatric population.)

En ensayos clínicos, la mayoría de los eventos adversos informados fueron de gravedad leve a moderada y de naturaleza transitoria. Durante estas investigaciones clínicas, 5.623 pacientes recibieron Lyflox. En el 2.2% de los pacientes, se suspendió la lomefloxacina debido a eventos adversos, que involucran principalmente el sistema gastrointestinal (0.7%), la piel (0.7%) o el SNC (0.5%).

Eventos clínicos adversos

Los eventos con mayor incidencia (≥ 1%) en pacientes, independientemente de la relación con el medicamento, fueron dolor de cabeza (3.6%), náuseas (3.5%), fotosensibilidad (2.3%), mareos (2.1%), diarrea (1.4%) y dolor abdominal (1.2%).

A continuación se enumeran los eventos clínicos adicionales informados en <1% de los pacientes tratados con Lyflox, independientemente de la relación con el medicamento

Autonómico: aumento de la sudoración, boca seca, enrojecimiento, síncope.

Cuerpo en su conjunto : fatiga, dolor de espalda, malestar general, astenia, dolor en el pecho, edema facial, sofocos, síntomas similares a la gripe, edema, escalofríos, reacción alérgica, reacción anafilactoide, disminución de la tolerancia al calor.

Cardiovascular: taquicardia, hipertensión, hipotensión, infarto de miocardio, angina de pecho, insuficiencia cardíaca, bradicardia, arritmia, flebitis, embolia pulmonar, extrasístoles, trastorno cerebrovascular, cianosis, miocardiopatía.

Sistema nervioso central y periférico: temblor, vértigo, parestesias, contracciones, hipertonía, convulsiones, hipercinesia, coma.

Gastrointestinal: dispepsia, vómitos, flatulencia, estreñimiento, sangrado gastrointestinal, disfagia, estomatitis, decoloración de la lengua, inflamación gastrointestinal.

Audiencia: dolor de oído, tinnitus.

Hematológico: púrpura, linfadenopatía, trombocitemia, anemia, trombocitopenia, aumento de la fibrinólisis.

Hepático: función hepática anormal.

Metabólico: sed, hiperglucemia, hipoglucemia, gota.

Musculoesquelético : artralgia, mialgia, calambres en las piernas.

Oftalmológico: visión anormal, conjuntivitis, fotofobia, dolor ocular, lagrimeo anormal.

Psiquiátrico: insomnio, nerviosismo, somnolencia, anorexia, depresión, confusión, agitación, aumento del apetito, despersonalización, reacción paranoica, ansiedad, paroniria, pensamiento anormal, deterioro de la concentración.

Sistema reproductivo: Mujer: moniliasis vaginal, vaginitis, leucorrea, trastorno menstrual, dolor perineal, sangrado intermenstrual. Macho: epididimitis, orquitis.

Mecanismo de resistencia : infección viral, moniliasis, infección por hongos.

Respiratorio: infección respiratoria, rinitis, faringitis, disnea, tos, epistaxis, broncoespasmo, trastorno respiratorio, aumento del esputo, estridor, depresión respiratoria.

Piel / Alérgico : prurito, erupción cutánea, urticaria, exfoliación cutánea, erupción ampollosa, eccema, trastorno de la piel, acné, decoloración de la piel, ulceración de la piel, angioedema. (Ver también Cuerpo en su conjunto.)

Sentidos especiales: perversión del gusto.

Urinario: hematuria, trastorno miccional, disuria, estrangulamiento, anuria.

Eventos adversos de laboratorio

Cambios en parámetros de laboratorio, enumerados como eventos adversos, sin tener en cuenta la relación con los medicamentos, incluyen:

Hematológico: monocitosis (0.2%), eosinofilia (0.1%), leucopenia (0.1%), leucocitosis (0.1%).

Renal: BUN elevado (0.1%), disminución de potasio (0.1%), aumento de creatinina (0.1%).

Hepático: elevaciones de ALT (SGPT) (0.4%), AST (SGOT) (0.3%), bilirrubina (0.1%), fosfatasa alcalina (0.1%).

Los cambios adicionales de laboratorio que ocurrieron en <0.1% en los estudios clínicos incluyeron: elevación de la gamma glutamil transferasa sérica, disminución de la proteína total o albúmina, prolongación del tiempo de protrombina, anemia, disminución de la hemoglobina, trombocitemia, trombocitopenia, anomalías de la gravedad específica de la orina o electrolitos séricos, aumento de albúmina, ESR elevado, albúmina elevada, albocitosis.

Eventos adversos posteriores a la comercialización

Eventos adversos posteriores a la comercialización

Los eventos adversos informados de la experiencia mundial de marketing con lomefloxacina son: anafilaxia, arresto cardiopulmonar, edema laríngeo o pulmonar, ataxia, trombosis cerebral, alucinaciones, dolorosa mucosa oral, colitis pseudomembranosa, anemia hemolítica, hepatitis, tendinitis, diplopía, fotofobia, fobia, dermatitis exfoliativa, hiperpigmentación, Síndrome de Stevens-Johnson, necrólisis epidérmica tóxica, disgeusia, nefritis intersticial, poliuria, insuficiencia renal, retención urinaria, y vasculitis.

Eventos adversos de clase quinolona

Los eventos adversos adicionales de la clase de quinolona incluyen: neuropatía periférica, torsades de pointes, eritema nodoso, necrosis hepática, posible exacerbación de miastenia gravis, disfasia, nistagmo, perforación intestinal, reacción maníaca, cálculos renales, acidosis e hipo.

Los eventos adversos de laboratorio incluyen: agranulocitosis, elevación de triglicéridos séricos, elevación del colesterol sérico, elevación de la glucosa en sangre, elevación del potasio sérico, albúinuria, candiduria y cristaluria.

La información sobre sobredosis en humanos es limitada. En caso de sobredosis aguda, el estómago debe vaciarse induciendo vómitos o lavado gástrico, y el paciente debe ser cuidadosamente observado y recibir tratamiento de apoyo. Se debe mantener una hidratación adecuada. Es poco probable que la hemodiálisis o la diálisis peritoneal ayuden a eliminar la lomefloxacina ya que estas modalidades eliminan <3%.

Los signos clínicos de toxicidad aguda en roedores progresaron de la salivación a los temblores, la disminución de la actividad, la disnea y las convulsiones clónicas antes de la muerte. Estos signos se observaron en ratas y ratones a medida que aumentaron las dosis de lomefloxacina.