Pharmacokinetic analysis of enoxaparin in a term neonate and review of literature

Mateos, Marion K.; Wright, Felicity A.; Cohn, Richard J.

doi:10.1016/j.thromres.2013.06.024

Cited by 9 publications

(7 citation statements)

References 28 publications

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“…A growing body of evidence shows that preterm neonates require higher doses of LMWH to achieve anti-factor Xa levels within target ranges 10, 11, 12, 13, 14, 15 . However, in the absence of large randomized controlled trials, and with much of our current understanding of pharmacokinetics extrapolated from adult studies, ideal dosing for anticoagulation in critically ill neonates remains uncertain 13, 16, 17, 18 . This dosing will ultimately depend on accurate descriptions of the morbidities of venous thrombosis in neonates, as well as the risks associated with LMWH therapy at different doses 9 .…”

Section: Introductionmentioning

confidence: 99%

Treatment and follow-up of venous thrombosis in the neonatal intensive care unit: a retrospective study

et al. 2016

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ObjectiveThe critically ill, premature patients of neonatal intensive care units are susceptible to venous thrombosis, an adverse event associated with short- and long-term morbidity. Venous thrombosis is frequently treated with low molecular weight heparins (LMWH) such as enoxaparin, but optimal dosing of LMWH must balance the morbidity of venous thrombosis with the potential adverse affects of anticoagulation. The optimal dosing of enoxaparin for premature infants is unclear. The objective of this study was to describe enoxaparin therapy and follow-up in critically ill neonates diagnosed with venous thrombosis.Study DesignRetrospective medical record review in the neonatal intensive care unit (NICU) in a single tertiary care institution. Infants with venous thrombosis diagnosed in the NICU were identified using pre-existing quality improvement lists and medical records.ResultsTwenty-six infants with 30 venous thromboses were identified with a median gestational age of 31 weeks at birth. Eighteen (69%) infants received enoxaparin for venous thrombosis during their hospitalization, beginning with a median dose of 1.5 mg/kg every 12h. This dose was increased to a median 2.1 mg/kg every 12h to achieve target anti-factor Xa levels. The target dose was significantly higher in patients with a postmenstrual age less than 37 weeks. Enoxaparin treatment was documented after discharge in 12 patients, continuing for a median of 99 days. Four patients died during hospitalization and their deaths were not attributable to venous thrombosis or anticoagulation complication. Follow-up documentation between 6 and 24 months after venous thrombosis diagnosis revealed no major morbidity of venous thrombosis or enoxaparin therapy.ConclusionsOur data reinforces the relative safety and necessity of enoxaparin doses above 1.5 mg/kg per 12 hours in most neonates. This was particularly true for infants at lower postmenstrual age.

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Section: Introductionmentioning

confidence: 99%

Treatment and follow-up of venous thrombosis in the neonatal intensive care unit: a retrospective study

et al. 2016

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“…20 This can also be problematic with very small doses, as a patient receiving a 1-mg dose would experience a 100% increase in dose with a whole-milligram titration. 3,21 We have also avoided using insulin syringes as a medication safety strategy.…”

Section: Discussionmentioning

confidence: 99%

“…The accurate delivery of medications to neonates and infants can be difficult. [1][2][3][4][5][6] The youngest patients often require manipulation of commercially available products to accurately administer doses of medications. Examples of this include compounding of oral medications in liquid formulations and dilution of injectable formulations to provide adequate volumes for very small doses.…”

Section: Introductionmentioning

confidence: 99%

Stability and Sterility of Enoxaparin 8 mg/mL Subcutaneous Injectable Solution

Moffett

Dinh

Placencia

et al. 2016

The Journal of Pediatric Pharmacology and Therapeutics

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Enoxaparin is often diluted to accurately deliver doses to neonatal and infant patients. Current recommendations for dilutions may not be adequate for the smallest patients. Review of dosing at our institution occurred, and an 8 mg/mL concentration of enoxaparin was chosen. A concentration of 8 mg/mL was compounded by diluting 0.4 mL of enoxaparin (100 mg/mL) into 4.6 mL of sterile water for injection into an empty sterile vial. Four syringes of the 8 mg/mL concentration were prepared by 5 technicians (20 total syringes). Stability and sterility testing occurred a 0, 7, 14, and 30 days. One-way repeated-measures analysis of variance was used to detect significant differences in Anti-Factor Xa concentrations at the testing time points. The dilution of enoxaparin was sterile at 30 days but exhibited significant degradation at the 30-day point (p < 0.05). A dilution of enoxaparin 8 mg/mL is stable and sterile for 14 days refrigerated but is not stable at 30 days.

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“…En este caso, también observaron el aumento de GGT de hasta 341 U/l. 9 Sin embargo, en un paciente pretérmino de 26 semanas con una edad corregida a término que estaba recibiendo tratamiento con enoxaparina para el manejo de una trombosis de la vena cava superior, otros autores 8 optaron por la administración fraccionada de sulfato de protamina (10, 15 y 10 mg a la 1,45, 4,5 y 7,5 horas del evento, respectivamente), con un valor de anti-Xa ≤ 2 U/ml como objetivo. Teniendo en cuenta que el valor de anti-Xa para la monitorización de la enoxaparina en la población pediátrica es extrapolado de estudios realizados en adultos, con valores recomendados de 0,5-1 U/ ml en caso del empleo con fines terapéuticos y de 0,1-0,3 U/ml cuando su uso es profiláctico, 10 en nuestro estudio, también se consideró un valor ≤ 2 U/ml adecuado en casos de sobredosificación, más aun cuando existían pocos estudios pediátricos que evaluaran la correlación entre la dosis de enoxaparina, los valores de anti-Xa y su eficacia clínica o la aparición de efectos adversos.…”

Section: Comentariounclassified

Sobredosis accidental de enoxaparina en un recién nacido

Gabriel

Movilla

Labián

et al. 2018

Arch Argent Pediatr

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Presentación de casos clínicos RESUMEN La enoxaparina es una heparina de bajo peso molecular utilizada en el período neonatal. Requiere menor monitoreo que la heparina estándar o no fraccionada, si bien es escaso el conocimiento actual acerca de su dosis y de los niveles terapéuticos en los neonatos. Además, existe una información muy limitada respecto del manejo de su sobredosificación en este grupo de edad. Se presenta el primer caso publicado en castellano de un neonato que recibió una dosis de enoxaparina diez veces superior a la terapéutica de forma accidental y en el que se administró una dosis aislada de protamina para revertir su efecto. Palabras clave: enoxaparina, errores de medicación, protaminas, recién nacido.

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Pharmacokinetic analysis of enoxaparin in a term neonate and review of literature

Cited by 9 publications

References 28 publications

Treatment and follow-up of venous thrombosis in the neonatal intensive care unit: a retrospective study

Treatment and follow-up of venous thrombosis in the neonatal intensive care unit: a retrospective study

Stability and Sterility of Enoxaparin 8 mg/mL Subcutaneous Injectable Solution

Sobredosis accidental de enoxaparina en un recién nacido

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