Presentation Outline ICHP Annual Meeting September 13-15
Presentation Outline ICHP Annual Meeting September 13-15
Presentation Outline ICHP Annual Meeting September 13-15
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Stability of Intravenous Acetaminophen (10 mg/mL) at Room<br />
Temperature in Varying Storage Containers<br />
Sample Actual Initial<br />
Drug<br />
Concentrationa (mg/mL)<br />
100 mg<br />
(syringe)<br />
250 mg<br />
(syringe)<br />
500 mg<br />
(syringe)<br />
250 mg<br />
(bottle)<br />
900 mg<br />
(bottle)<br />
% Initial Concentration Remaining<br />
24 hours 48 hours 72 hours 84 hours<br />
9.94 ± 0.05 99.11 ± 0.52 100.54 ± 0.69 100.08 ± 0.38 100.02 ±0.53<br />
9.96 ± 0.02 99.66 ± 1.11 99.61 ± 0.68 99.83 ± 0.89 99.80 ±0.35<br />
9.96 ± 0.03 100.<strong>13</strong> ± 0.37 99.83 ± 0.64 99.92 ± 058 99.68 ±0.55<br />
9.98 ± 0.03 99.67 ± 0.36 100.07 ± 1.26 99.37 ± 0.24 99.53 ±0.41<br />
9.93 ± 0.04 99.76 ± 0.33 100.03 ± 0.59 100.54 ± 0.58 100.31 ±1.22<br />
a Mean ±S.D. of duplicate determinants for three samples (n = 3).<br />
Conclusion<br />
• Intravenous acetaminophen (10 mg/mL) was<br />
physically and chemically stable in a range of volumes<br />
for up to 84 hours in the opened bottles and in<br />
polypropylene syringes<br />
References<br />
1. Babl FE, Theophilos T, Palmer GM. Is there a role for intravenous<br />
acetaminophen in pediatric emergency departments? Pediatr Emerg<br />
Care. 2011;27(6):496‐9.<br />
2. Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin.<br />
2010;28(4):619‐45.<br />
3. Martindale –The Complete Drug Reference. 35th ed. London:<br />
Pharmaceutical Press; 2007.<br />
4. Koshy KT, Lach JL. Stability of aqueous solutions of N‐acetyl‐p‐<br />
aminophenol. J Pharm Sci. 1961;50:1<strong>13</strong>‐8.<br />
5. Menezes HA, Maia G. Films formed by the electrooxidation of p‐<br />
aminophenol (p‐APh) in aqueous medium: What do they look like? J<br />
Electroanal Chem. 2006; 586(1):39‐48.<br />
6. OFIRMEV (intravenous acetaminophen) package insert. San Diego, CA:<br />
Cadence Pharma; 2010 Nov.<br />
Results<br />
• No detectable change in sample color<br />
• No visible drug precipitation<br />
• No appreciable change in the initial pH (5.77 ±0.02)<br />
• Interday coefficient of variation: 1.8%<br />
• Intraday coefficient of variation: 1%<br />
Significance<br />
• Benefits of extending the stability of<br />
intravenous acetaminophen<br />
– Decreased product waste<br />
– Cost savings to patients and the healthcare system<br />
– Pharmacy workflow optimized by minimizing need<br />
for urgent dose preparation<br />
References<br />
7. Rowe RC, Sheskey PJ, Owen SC. Handbook of pharmaceutical excipients.<br />
American Pharmacists Associations. 5th ed. London; Pharmaceutical<br />
Press; 2006.<br />
8. Schmitt E, Vainchtock A, Nicoloyannis N et al. Ready to use injectable<br />
paracetamol: easier, safer, lowering workload and costs. EJHP 2003 6:96‐<br />
102.<br />
9. USP Guidebook to Pharmaceutical Compounding— Sterile<br />
Preparations. The United States Pharmacopeia, 34th revision, and The<br />
National Formulary, 29th ed. Rockville, MD: United States Pharmacopeial<br />
Convention; 2010:336‐73.<br />
10. ASHP guidelines on quality assurance for pharmacy‐prepared sterile<br />
products. American Society of Health System Pharmacists. Am J Health<br />
Syst Pharm. 2000;57(12):1<strong>15</strong>0‐69.<br />
11. Acetaminophen. The United States Pharmacopeia, 34th revision, and The<br />
National Formulary, 29th ed. Rockville, MD: United States Pharmacopeial<br />
Convention; 2010:1720‐3.<br />
8/29/2012<br />
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