Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics

William E. Dager, Robert C. Gosselin, Jeffery H. King, Cinda L. Christensen, John T Owings, Edward C. Larkin

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: The use of enoxaparin in low-weight pediatric patients is becoming common practice. Anti-Xa stability of unit-dose syringes prepared after dilution beyond one day is presently unknown. OBJECTIVE: To evaluate the anti-Xa stability of diluted enoxaparin stored in glass vials and tuberculin syringes. METHODS: Four separate batches of enoxaparin were diluted with sterile water to a final concentration of 20 mg/mL (2000 IU/mL) and aliquoted into plastic 1-mL syringes containing 6 mg (0.3 mL) or maintained in the glass vial. Syringes were stored at room temperature or under refrigeration. The glass vial used for diluting was stored at room temperature. The anti-Xa activity was measured on the date of preparation to 4 weeks. Statistical comparisons determined whether differences in anti-Xa activity in diluted enoxaparin are affected by the storage medium or temperature. A paired t-test was used to determine any significant differences between the anti-Xa activity on date of preparation (baseline) and subsequent time periods, with p < 0.05 considered statistically significant. RESULTS: The mean baseline anti-Xa activity was 2607 IU/mL (95% CI 2300 to 2914). No measurable decrease occurred in diluted enoxaparin anti-Xa activity in the glass vial maintained over the 4-week period. Compared with the glass vial, room temperature and refrigerated syringe samples had trending decreases of anti-Xa activity at weeks 3 and 4, but did not reach statistical significance. CONCLUSIONS: A nonsignificant decrease in anti-Xa activity occurred starting at day 22 for the diluted enoxaparin in tuberculin syringes, regardless of storage temperature. Storage up to 4 weeks of diluted enoxaparin in glass or prefilled syringes does not result in a statistically significant loss of anticoagulant potential, as measured by anti-Xa activity.

Original languageEnglish (US)
Pages (from-to)569-573
Number of pages5
JournalAnnals of Pharmacotherapy
Volume38
Issue number4
DOIs
StatePublished - Apr 2004

Fingerprint

Enoxaparin
Syringes
Glass
Pediatrics
Temperature
Tuberculin
Refrigeration
Anticoagulants
Plastics
Weights and Measures
Water

Keywords

  • Enoxaparin
  • Low-molecular-weight heparin
  • Pediatrics
  • Stability

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Dager, W. E., Gosselin, R. C., King, J. H., Christensen, C. L., Owings, J. T., & Larkin, E. C. (2004). Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics. Annals of Pharmacotherapy, 38(4), 569-573. https://doi.org/10.1345/aph.1D107

Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics. / Dager, William E.; Gosselin, Robert C.; King, Jeffery H.; Christensen, Cinda L.; Owings, John T; Larkin, Edward C.

In: Annals of Pharmacotherapy, Vol. 38, No. 4, 04.2004, p. 569-573.

Research output: Contribution to journalArticle

Dager, WE, Gosselin, RC, King, JH, Christensen, CL, Owings, JT & Larkin, EC 2004, 'Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics', Annals of Pharmacotherapy, vol. 38, no. 4, pp. 569-573. https://doi.org/10.1345/aph.1D107
Dager WE, Gosselin RC, King JH, Christensen CL, Owings JT, Larkin EC. Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics. Annals of Pharmacotherapy. 2004 Apr;38(4):569-573. https://doi.org/10.1345/aph.1D107
Dager, William E. ; Gosselin, Robert C. ; King, Jeffery H. ; Christensen, Cinda L. ; Owings, John T ; Larkin, Edward C. / Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics. In: Annals of Pharmacotherapy. 2004 ; Vol. 38, No. 4. pp. 569-573.
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abstract = "BACKGROUND: The use of enoxaparin in low-weight pediatric patients is becoming common practice. Anti-Xa stability of unit-dose syringes prepared after dilution beyond one day is presently unknown. OBJECTIVE: To evaluate the anti-Xa stability of diluted enoxaparin stored in glass vials and tuberculin syringes. METHODS: Four separate batches of enoxaparin were diluted with sterile water to a final concentration of 20 mg/mL (2000 IU/mL) and aliquoted into plastic 1-mL syringes containing 6 mg (0.3 mL) or maintained in the glass vial. Syringes were stored at room temperature or under refrigeration. The glass vial used for diluting was stored at room temperature. The anti-Xa activity was measured on the date of preparation to 4 weeks. Statistical comparisons determined whether differences in anti-Xa activity in diluted enoxaparin are affected by the storage medium or temperature. A paired t-test was used to determine any significant differences between the anti-Xa activity on date of preparation (baseline) and subsequent time periods, with p < 0.05 considered statistically significant. RESULTS: The mean baseline anti-Xa activity was 2607 IU/mL (95{\%} CI 2300 to 2914). No measurable decrease occurred in diluted enoxaparin anti-Xa activity in the glass vial maintained over the 4-week period. Compared with the glass vial, room temperature and refrigerated syringe samples had trending decreases of anti-Xa activity at weeks 3 and 4, but did not reach statistical significance. CONCLUSIONS: A nonsignificant decrease in anti-Xa activity occurred starting at day 22 for the diluted enoxaparin in tuberculin syringes, regardless of storage temperature. Storage up to 4 weeks of diluted enoxaparin in glass or prefilled syringes does not result in a statistically significant loss of anticoagulant potential, as measured by anti-Xa activity.",
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AB - BACKGROUND: The use of enoxaparin in low-weight pediatric patients is becoming common practice. Anti-Xa stability of unit-dose syringes prepared after dilution beyond one day is presently unknown. OBJECTIVE: To evaluate the anti-Xa stability of diluted enoxaparin stored in glass vials and tuberculin syringes. METHODS: Four separate batches of enoxaparin were diluted with sterile water to a final concentration of 20 mg/mL (2000 IU/mL) and aliquoted into plastic 1-mL syringes containing 6 mg (0.3 mL) or maintained in the glass vial. Syringes were stored at room temperature or under refrigeration. The glass vial used for diluting was stored at room temperature. The anti-Xa activity was measured on the date of preparation to 4 weeks. Statistical comparisons determined whether differences in anti-Xa activity in diluted enoxaparin are affected by the storage medium or temperature. A paired t-test was used to determine any significant differences between the anti-Xa activity on date of preparation (baseline) and subsequent time periods, with p < 0.05 considered statistically significant. RESULTS: The mean baseline anti-Xa activity was 2607 IU/mL (95% CI 2300 to 2914). No measurable decrease occurred in diluted enoxaparin anti-Xa activity in the glass vial maintained over the 4-week period. Compared with the glass vial, room temperature and refrigerated syringe samples had trending decreases of anti-Xa activity at weeks 3 and 4, but did not reach statistical significance. CONCLUSIONS: A nonsignificant decrease in anti-Xa activity occurred starting at day 22 for the diluted enoxaparin in tuberculin syringes, regardless of storage temperature. Storage up to 4 weeks of diluted enoxaparin in glass or prefilled syringes does not result in a statistically significant loss of anticoagulant potential, as measured by anti-Xa activity.

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