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Revisión médica por Oliinyk Elizabeth Ivanovna Última actualización de farmacia el 02.04.2022
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Lincomicina MKCIN Solution estéril está indicada en el tratamiento de infecciones graves debido a cepas susceptibles de estreptococos, neumococos y estafilococos. Su uso debe reservarse para pacientes alérgicos a la penicilina u otros pacientes para quienes, a juicio del médico, una penicilina es inapropiada. Debido al riesgo de colitis pseudomembranosa asociada a antibacterianos, como se describe en el Caja de ADVERTENCIA, antes de seleccionar Lincomicina MKmycin, el médico debe considerar la naturaleza de la infección y la idoneidad de las alternativas menos tóxicas (p. Ej., eritromicina).
Los procedimientos quirúrgicos indicados deben realizarse junto con la terapia antibacteriana.
El medicamento puede administrarse concomitantemente con otros agentes antimicrobianos cuando esté indicado.
Lincomicina MKmycin no está indicado en el tratamiento de infecciones bacterianas menores o infecciones virales.
Para reducir el desarrollo de bacterias resistentes a los medicamentos y mantener la efectividad de Lincomicina MKCIN y otros medicamentos antibacterianos, Lincomicina MKCIN 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.
Si se produce diarrea significativa durante la terapia, este antibacteriano debe suspenderse. (ver ADVERTENCIA DE LA CAJA.)
Intramuscular
Adultos
Infecciones graves—600 mg (2 ml) por vía intramuscular cada 24 horas. Infecciones más graves—600 mg (2 ml) por vía intramuscular cada 12 horas o más a menudo.
Pacientes pediátricos mayores de 1 mes de edad
Infecciones graves—Una inyección intramuscular de 10 mg / kg (5 mg / lb) cada 24 horas. Infecciones más graves—Una inyección intramuscular de 10 mg / kg (5 mg / lb) cada 12 horas o más a menudo.
Intravenoso
Adultos
La dosis intravenosa se determinará por la gravedad de la infección. Para infecciones graves, se administran dosis de 600 mg de Lincomicina MKmycin (2 ml de Lincomicina MKCIN) a 1 gramo cada 8 a 12 horas. Para infecciones más graves, estas dosis pueden tener que aumentarse. En situaciones potencialmente mortales, se han administrado dosis intravenosas diarias de hasta 8 gramos. Las dosis intravenosas se administran en base a 1 gramo de Lincomicina MKmycin diluido en no menos de 100 ml de solución apropiada (ver Compatibidades físicas) e infundido durante un período de no menos de una hora.
Dosis | Vol. Diluyente | Hora |
600 mg | 100 ml | 1 hora |
1 gramo | 100 ml | 1 hora |
2 gramos | 200 ml | 2 h |
3 gramos | 300 ml | 3 h |
4 gramos | 400 ml | 4 h |
Estas dosis pueden repetirse con la frecuencia requerida hasta el límite de la dosis diaria máxima recomendada de 8 gramos de Lincomicina MKmycin.
Pacientes pediátricos mayores de 1 mes de edad
10 a 20 mg / kg / día (5 a 10 mg / lb / día) dependiendo de la gravedad de la infección, se puede infundir en dosis divididas como se describió anteriormente para adultos.
Reportado con inyección intramuscular.
NOTA: Se han producido reacciones cardiopulmonares graves cuando este medicamento se ha administrado a una concentración y tasa superiores a las recomendadas.
Inyección subconjuntival
0.25 ml (75 mg) inyectados subconjuntivalmente darán como resultado niveles de líquido ocular de antibacteriano (que duran al menos 5 horas) con MIC suficientes para los patógenos más susceptibles.
Pacientes con función renal disminuida
Cuando se requiere terapia con Lincomicina MKCIN en individuos con insuficiencia grave de la función renal, una dosis apropiada es del 25 al 30% de la recomendada para pacientes con riñones que funcionan normalmente.
Compatibilidades físicas
Físicamente compatible durante 24 horas a temperatura ambiente a menos que se indique lo contrario.
Soluciones de infusión
5% de inyección de dextrosa
10% de inyección de dextrosa
5% de dextrosa y 0.9% de inyección de cloruro de sodio
10% de dextrosa y 0.9% de inyección de cloruro de sodio
Inyección de timbre
Inyección de lactato de sodio 1/6 M
Travertir 10% -Electrolyte No. 1)
Dextrano en solución salina 6% p / v
Vitaminas en soluciones de infusión
B-complejo
B-Complejo con ácido ascórbico
Soluciones antibacterianas en infusión
Penicilina G Sodio (satisfactorio durante 4 horas)
Cefalotina
Tetraciclina HCl
Cefaloridina
Colistimetato (satisfactorio durante 4 horas)
Ampicilina
Meticilina
Cloranfenicol
Sulfato de polimixina B
Físicamente incompatible con
Novobiocina
Kanamicina
DEBE SER DESEADO DE QUE LAS DETERMINACIONES COMPATIBLES E INCOMPATIBLES SON SOLO OBSERVACIONES FÍSICAS, NO DETERMINACIONES QUÍMICAS. EVALUACIÓN CLÍNICA ADECUADA DE LA SEGURIDAD Y EFICACIA DE ESTAS COMBINACIONES NO SE HA REALIZADO
Este medicamento está contraindicado en pacientes que anteriormente eran hipersensibles a Lincomicina MKmycin o clindamicina.
WARNINGS
see BOX WARNING.
Clostridium Difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomicina MKmycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Hypersensitivity
Serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of Lincomicina MKCIN. If an allergic reaction to Lincomicina MKCIN occurs, discontinue the drug. (see ADVERSE REACTIONS)
Benzyl Alcohol Toxicity In Pediatric Patients (Gasping Syndrome)
This product contains benzyl alcohol as a preservative.
The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.
Use in Meningitis — Although Lincomicina MKmycin appears to diffuse into cerebrospinal fluid, levels of Lincomicina MKmycin in the CSF may be inadequate for the treatment of meningitis.
PRECAUTIONS
General
Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When Lincomicina MKCIN is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Lincomicina MKCIN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Lincomicina MKCIN should be used with caution in patients with a history of asthma or significant allergies.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.
The use of Lincomicina MKCIN may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with Lincomicina MKCIN, concomitant antimonilial treatment should be given.
The serum half-life of Lincomicina MKmycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function.
Patients with severe impairment of renal function and/or abnormal hepatic function should be dosed with caution and serum Lincomicina MKmycin levels monitored during high-dose therapy. (see DOSAGE AND ADMINISTRATION)
Lincomicina MKmycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the DOSAGE AND ADMINISTRATIONSection.
Prescribing Lincomicina MKCIN 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.
Laboratory Tests
During prolonged therapy with Lincomicina MKCIN, periodic liver and kidney function tests and blood counts should be performed.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
The carcinogenic potential of Lincomicina MKmycin has not been evaluated.
Lincomicina MKmycin was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, Lincomicina MKmycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, Lincomicina MKmycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.
Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of Lincomicina MKmycin (0.36 times the highest recommended human dose based on mg/m2 ).
Pregnancy
Pregnancy Category C
Lincomicina MKCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS.
Teratogenic Effects
There are no studies on the teratogenic potential of Lincomicina MKmycin in animals or adequate and wellcontrolled studies of pregnant women.
Nonteratogenic Effects
Reproduction studies have been performed in rats using oral doses of Lincomicina MKmycin up to 1000 mg/kg (1.2 times the maximum daily human dose based on mg/m2 ) and have revealed no adverse effects on survival of offspring from birth to weaning.
Nursing Mothers
Lincomicina MKmycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 μg/mL. Because of the potential for serious adverse reactions in nursing infants from Lincomicina MKCIN, 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
Lincomicina MKCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. See WARNINGS. Safety and effectiveness in pediatric patients below the age of one month have not been established. (see DOSAGE AND ADMINISTRATION)
The following reactions have been reported with the use of Lincomicina MKmycin and are listed by System Organ Class.
Gastrointestinal Disorders
Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort1 , anal pruritus
1Event has been reported with intravenous injection.
Skin And Subcutaneous Tissue Disorders
Rash, urticaria, pruritus, Stevens-Johnson syndrome, erythema multiforme (see WARNINGS), dermatitis bullous, dermatitis exfoliative
Infections And Infestations
Vaginal infection, pseudomembranous colitis, Clostridium difficile colitis (see WARNINGS)
Blood And Lymphatic System Disorders
Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura
Immune System Disorders
Anaphylactic reaction (see WARNINGS), angioedema, serum sickness
Hepatobiliary Disorders
Jaundice, liver function test abnormal, transaminases increased
Renal And Urinary Disorders
Renal impairment, oliguria, proteinuria, azotemia
Cardiac Disorders
Cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION)
Vascular Disorders
Hypotension (see DOSAGE AND ADMINISTRATION), thrombophlebitis1
Ear And Labyrinth Disorders
Vertigo, tinnitus
Neurologic Disorders
Headache, dizziness, somnolence
General Disorders And Administration Site Conditions
Injection site abscess sterile2 , injection site induration2 , injection site pain2 , injection site irritation2
2 Reported with intramuscular injection.
Los niveles séricos de Lincomicina MKmycin no se ven apreciablemente afectados por la hemodiálisis y la diálisis peritoneal.