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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 />

5

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