Literature DB >> 27713671

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

Brady S Moffett1, Kimberly Dinh1, Jennifer Placencia1, Gregory Pelkey2, Shiu-Ki Rocky Hui3, Jun Teruya3.   

Abstract

BACKGROUND: 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.
METHODS: 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.
RESULTS: The dilution of enoxaparin was sterile at 30 days but exhibited significant degradation at the 30-day point (p < 0.05).
CONCLUSION: A dilution of enoxaparin 8 mg/mL is stable and sterile for 14 days refrigerated but is not stable at 30 days.

Entities:  

Keywords:  Anti–Factor Xa concentrations; enoxaparin; low molecular weight heparin; neonates; stability; sterility

Year:  2016        PMID: 27713671      PMCID: PMC5040175          DOI: 10.5863/1551-6776-21.4.322

Source DB:  PubMed          Journal:  J Pediatr Pharmacol Ther        ISSN: 1551-6776


  21 in total

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

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4.  Clinical experiences with low-molecular weight heparins in pediatric patients.

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5.  Population pharmacokinetics of enoxaparin in infants, children and adolescents during secondary thromboembolic prophylaxis: a cohort study.

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7.  The use of low molecular weight heparin in pediatric patients: a prospective cohort study.

Authors:  D Dix; M Andrew; V Marzinotto; K Charpentier; S Bridge; P Monagle; G deVeber; M Leaker; A K Chan; M P Massicotte
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8.  Enoxaparin use in the neonatal intensive care unit: experience over 8 years.

Authors:  Janet I Malowany; David C Knoppert; Anthony K C Chan; Dion Pepelassis; David S C Lee
Journal:  Pharmacotherapy       Date:  2007-09       Impact factor: 4.705

9.  Evaluation of enoxaparin dosing requirements in infants and children. Better dosing to achieve therapeutic levels.

Authors:  Mary E Bauman; Mark J Belletrutti; Laszlo Bajzar; Karina L Black; Stefan Kuhle; Michelle L Bauman; M Patricia Massicotte
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10.  Novel uses of insulin syringes to reduce dosing errors: a retrospective chart review of enoxaparin whole milligram dosing.

Authors:  M E Bauman; K L Black; M L Bauman; Mark Belletrutti; L Bajzar; M P Massicotte
Journal:  Thromb Res       Date:  2008-11-26       Impact factor: 3.944

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