Ethanol 5% and Dextrose 5% for Injection

19 September 2008

Products Affected - Description

Ethanol 5% (v/v) and Dextrose 5% in Water (D5W) for injection, Hospira
1000 mL infusion bag, package of 6 (NDC 00409-1500-05) - discontinued

Reason for the Shortage

Hospira discontinued manufacturing this product in November 2007 for business reasons.¹

Estimated Resupply Dates

• Hospira has no product in stock and has discontinued manufacturing.¹
• There are no other suppliers of this product.

Implications for Patient Care

• Ethanol 5% in D5W is used as an antidote for methanol or ethylene glycol ingestion. Ethanol competitively inhibits metabolism of these substances by alcohol dehydrogenase, preventing formation of toxic metabolites. Patients undergo concomitant hemodialysis to remove the methanol or ethylene glycol.^2-4
• Fomepizole is labeled for treatment of methanol or ethylene glycol ingestion.⁵ Some patients require concomitant hemodialysis to remove the methanol or ethylene glycol.^6-8

Safety

• Patients receiving ethanol therapeutically may become sedated or intoxicated. Monitor patients closely during therapy.
• Use caution when calculating ethanol doses. Ethanol products are available in many strengths and concentrations may be given as volume/volume (v/v) or as weight/volume (w/v). In addition, oral ethanol may be marked with proof strength as well as percent concentration.
• Therapy must be continued until serum concentration of methanol or ethylene glycol is less than 20 mg/dL, pH is normal, and patient is clinically stable.^2,3

Alternative Agents & Management

• Fomepizole is labeled for treatment of methanol or ethylene glycol ingestion. Some patients require concomitant hemodialysis to remove the methanol or ethylene glycol.^6-8
• American Regent has ethanol injection available in 1 mL and 5 mL ampules; the concentration of this preparation varies from 98% to 99.5% (v/v). ^9,11 Ethanol 98% to 99.5% (v/v) injection is labeled for therapeutic neurolysis for the relief of intractable chronic nerve pain. ¹² This product must be diluted to 5% prior to IV administration. Use caution to avoid preparation errors because preparations may be ordered as volume/volume (v/v) or weight/volume (w/v) concentrations. Clinicians should consider contacting a regional poison center at 800-222-1222 for assistance with calculations. No compatibility or stability data are available for IV admixtures prepared from this formulation.
• Oral ethanol may be an alternative in patients who can have a nasogastric tube placed. Because absorption is less predictable with oral administration, this route is usually not preferred.^2,3
• The table compares the dosage regimens of antidotes for methanol and ethylene glycol ingestion.
• Clinicians should consider contacting a regional poison center at 800-222-1222 for assistance in antidote selection and use.

Table. Antidote Dosage Regimens^2-4,6-13

Agent	Loading Dose	Maintenance Dose	Notes
Fomepizole	Fomepizole 15 mg/kg IV, up to a maximum of 1000 mg	Fomepizole 10 mg/kg IV every 12 hours for 48 hours, then 15 mg/kg every 12 hours. During hemodialysis: give next scheduled dose at beginning of hemodialysis if 6 hours or more since last dose. Then administer every 4 hours during hemodialysis. At end of hemodialysis session, give supplemental dose as below, then return to every 12 hour schedule: Give nothing if < 1 hour since previous dose. Give 50% of next scheduled dose if 1 to 3 hours since previous dose. Give next scheduled dose if > 3 hours since previous dose.	Dilute to at least 100 mL with 0.9% Sodium Chloride or Dextrose 5% in Water injection. Infuse over 30 minutes. Maintain serum fomepizole concentration > 15 mg/L during therapy. Continue until methanol or ethylene glycol concentration < 20 mg/dL.
Ethanol 5% (v/v) injectiona (3.95 g ethanol/dL)	Ethanol 5% injection 15 mL/kg IV over 1 hour Reduce dose if serum ethanol > 0 mg/dL: Adjusted loading dose = Normal loading dose X (100 - serum ethanol [mg/dL])/100	Nondrinker: ethanol 5% injection 2 mL/kg/hour by continuous IV infusion. Increase to 4 mL/kg/hour during hemodialysis. Chronic drinker: ethanol 5% injection 4 mL/kg/hour by continuous IV infusion. Increase to 7 mL/kg/hour during hemodialysis.	Maintain serum ethanol concentration between 100 to 200 mg/dL during therapy. Continue until methanol or ethylene glycol concentration < 20 mg/dL. Because the commercially available product has been discontinued, these preparations must be compounded from ethanol 98% to 99.5% (v/v) injection. Ethanol 98% to 99.5% injection must be diluted to 5% prior to IV administration. Some institutions may choose not to compound ethanol injection because of regulatory requirements (i.e., USP Chapter 797).
Ethanol 43% oral solution (86 proof), approximate concentration of most commercially available rum, gin, vodka, or whiskey)12	Ethanol 43% solution 1.8 mL/kg orally (after 1:1 dilution, give 3.6 mL/kg)	Nondrinker: ethanol 43% solution 0.2 mL/kg/hour (after 1:1 dilution, 0.4 mL/kg/hour) continuous nasogastric infusion. Increase to 0.5 mL/kg/hour (after 1:1 dilution, 1 mL/kg/hour) during hemodialysis. Chronic drinker: ethanol 43% solution 0.46 mL/kg/hour (after 1:1 dilution, 0.92 mL/kg/hour) continuous nasogastric infusion. Increase to 0.77 mL/kg/hour (after 1:1 dilution, 1.54 mL/kg/hour) during hemodialysis.	Dilute with juice to 20% solution prior to administration. For practical purposes, a 1:1 dilution may be used. Maintain serum ethanol concentration between 100 to 200 mg/dL during therapy. Continue until methanol or ethylene glycol concentration < 20 mg/dL
Everclear 151 grain alcohol, supplies ethanol 75.5% oral solution (151 proof)13b	Ethanol 75.5% solution 1.02 mL/kg orally (after 3:1 dilution, give 4.1 mL/kg)	Nondrinker: ethanol 75.5% solution 0.11 mL/kg/hour (after 3:1 dilution, 0.46 mL/kg/hour) continuous nasogastric infusion. Increase to 0.28 mL/kg/hour (after 3:1 dilution, 1.14 mL/kg/hour) during hemodialysis. Chronic drinker: ethanol 75.5% solution 0.26 mL/kg/hour (after 3:1 dilution, 1.05 mL/kg/hour) continuous nasogastric infusion. Increase to 0.44 mL/kg/hour (after 1:1 dilution, 1.75 mL/kg/hour) during hemodialysis.	Dilute with juice to 20% solution prior to administration. For practical purposes, a 3:1 juice:Everclear dilution may be used. Maintain serum ethanol concentration between 100 to 200 mg/dL during therapy. Continue until methanol or ethylene glycol concentration < 20 mg/dL.
Everclear 190 grain alcohol, supplies ethanol 95% oral solution (190 proof)13b	Ethanol 95% solution 0.81 mL/kg orally (after 4:1 dilution, give 4.1 mL/kg)	Nondrinker: ethanol 95% solution 0.09 mL/kg/hour (after 4:1 dilution, 0.45 mL/kg/hour) continuous nasogastric infusion. Increase to 0.23 mL/kg/hour (after 4:1 dilution, 1.13 mL/kg/hour) during hemodialysis. Chronic drinker: ethanol 95% solution 0.21 mL/kg/hour (after 4:1 dilution, 1.04 mL/kg/hour) continuous nasogastric infusion. Increase to 0.35 mL/kg/hour (after 4:1 dilution, 1.74 mL/kg/hour) during hemodialysis.	Dilute with juice to 20% solution prior to administration. For practical purposes, a 4:1 juice:Everclear dilution may be used. Maintain serum ethanol concentration between 100 to 200 mg/dL during therapy. Continue until methanol or ethylene glycol concentration < 20 mg/dL.

^aHospira has discontinued ethanol 5% injection and has no product in stock.
^bThis product is available in both 151 proof (75.5% ethanol) and 190 proof (95% ethanol) concentrations. The 190 proof product is illegal in some areas.¹³ Consult local alcohol enforcement agencies and regulations for information on product availability in your area.

Related Shortages

References

1. Hospira. Customer Service (personal communications). December 19, 2007.
2. Alcohol, ethyl [antidote]. Lexi-Comp OnlineTM, Poisoning & Toxicology Handbook, Hudson-OH: Lexi-Comp, Inc.; 2007; December 21, 2007.
3. Alcohol, ethyl. Lexi-Comp OnlineTM, Lexi-Drugs Online, Hudson-OH: Lexi-Comp, Inc.; 2007; December 21, 2007.
4. Kearney TE. Ethanol. In: Olson KR, ed. Poisoning & Drug Overdose, 4th ed. New York, NY: Lange Medical Books / McGraw-Hill; 2004:444-446.
5. Fomepizole [antidote]. Lexi-Comp OnlineTM, Poisoning & Toxicology Handbook, Hudson-OH: Lexi-Comp, Inc.; 2007; December 21, 2007.
6. Fomepizole. Lexi-Comp OnlineTM, Lexi-Drugs Online, Hudson-OH: Lexi-Comp, Inc.; 2007; December 21, 2007.
7. Kearney TE. Fomepizole (4-methylpyrazole, 4-MP). In: Olson KR, ed. Poisoning & Drug Overdose, 4th ed. New York, NY: Lange Medical Books / McGraw-Hill; 2004:448-449.
8. Antizol (fomepizole) injection. Prescribing Information. Palo Alto, CA: JAZZ Pharmaceuticals; April 2006.
9. American Regent. Customer Service (personal communications). December 21, 2007.
10. Dehydrated alcohol injection, USP. Prescribing Information. Shirley, NY: American Regent; January 2003.
11. Red Book. 2008 edition. Montvale, NJ: Thomson Healthcare; 2008.
12. Ethanol. In: POISONDEX® System [Internet database]. Accessed on January 2, 2008. Greenwood Village, CO: Thomson Healthcare; 2008 (Updated periodically).
13. Wikipedia. Everclear (alcohol). Available at http://en.wikipedia.org/wiki/Everclear_%28alcohol%29. Accessed January 2, 2008.

Updated

Updated January 19, 2008 by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Created December 21, 2007 by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Copyright 2008, Drug Information Service, University of Utah, Salt Lake City, UT.

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