Erythromycin Ophthalmic Ointment

10 November 2009

Products Affected - Description

Erythromycin Ophthalmic Ointment, 5 mg/gram
3.5 gram tube (NDC 17478-0070-35), Akorn - discontinued

Erythromycin Ophthalmic Ointment, 5 mg/gram
1 gram tube, package of 50 (NDC 00168-0070-11), Fougera - discontinued
3.5 gram tube, package of 1 (NDC 00168-0070-38), Fougera - discontinued
3.5 gram tube, package of 24 (NDC 00168-0070-39), Fougera - discontinued

Erythromycin Ophthalmic Ointment, 5 mg/gram
3.5 gram tube, package of 1 (NDC 00223-4288-03), Consolidated Midland - discontinued

Reason for the Shortage

• Akorn Consolidated Midland have discontinued their products.^1,2
• Fougera has sold erythromycin ophthalmic ointment, along with six other ophthalmic ointments, to Fera Pharmaceuticals. Fera estimates erythromycin ophthalmic ointment will be available in 2010. ^3,4
• Bausch and Lomb and Ocusoft have product on shortage due to increased demand for the product.^5,6
• Wilson has discontinued their erythromycin ophthalmic ointment. The company could not provide a reason for this discontinuation.⁷

Estimated Resupply Dates

• Bausch and Lomb has their product on intermittent back order and the company is releasing product as it becomes available.⁵
• Ocusoft has Romycin ophthalmic ointment in 3.5 gram tubes (NDC 54799-0540-35) on intermittent back order. They distribute product manufactured by Bausch and Lomb. This product can only be ordered direct with a credit card.⁶
• Wilson Ophthalmic has discontinued their erythromycin ophthalmic ointment.⁷

Implications for Patient Care

• Erythromycin 0.5% ophthalmic ointment is labeled for neonatal ophthalmia prophylaxis.⁸
• The Centers for Disease Control and Prevention (CDC) has detailed guidance on alternative agents .⁹ Agents suggested in some sources ^10-12such as tetracycline 1% ophthalmic ointment, silver nitrate 1% ophthalmic solution, and povidone-iodine 2.5% ophthalmic solution are not commercially available and are not recommended as alternatives.⁹

Safety

• Clincians must ensure sterility is maintained if larger tubes of erythromycin 0.5% ophthalmic ointment are repackaged into unit of use presentations.^13,14 
• CDC does not recommend using povidone iodine as an alternative.⁹
• CDC has received reports of adverse events with gentamicin ophthalmic ointment.9
• The Institute for Safe Medication Practices (ISMP) has reported that at least one pharmacy is compounding erythromycin for ophthalmic use in parenteral syringes. ISMP is recommending the use of oral syringes with “For the Eyes” labels covering the “Oral Use Only” to prevent potential intravenous administration.¹⁵
  
  

Alternative Agents & Management

• There are no commercially available alternatives labeled for neonatal ophthalmia prophylaxis.
• CDC recommends the following actions during this shortage.9
  • Review current inventory and reserve all remaining supplies of erythromycin ophthalmic ointment (0.5%) for neonatal ophthalmia prophylaxis.
  • Work with your wholesaler to place backorders; Bausch and Lomb customer service may also be reached at 1-800-323-0000.
  • Azithromycin ophthalmic solution 1% 1 to 2 drops in each eye, is an alternative. This recommendation is based on pharmacologic and microbiologic activity as no clinical data are available. Drops may be difficult to administer because azithromycin ophthalmic solution is a thick liquid.¹⁶ Consider using 2 people to assure proper placement. Specific administration instructions are available.¹⁶
  • Second-line alternative agents include gentamicin ophthalmic ointment (0.3%) or tobramycin ophthalmic ointment (0.3%).
  • A third-line alternative agent is ciprofloxacin ophthalmic ointment 0.3%. This is not a first-line agent due to gonococcal antimicrobial resistance.
  • Additionally or alternatively, test mothers for chlamydia and gonorrhea before delivery. Use empiric treatment for infants exposed to gonorrhea. Monitor infants exposed to chlamydia for symptoms before initiating treatment. CDC’s 2006 STD Treatment Guidelines provide detailed recommendations.¹⁷
  • Monitor infants for potential prophylaxis failure. Evaluate for ophthalmia neonatorum during the first postnatal visit (48 to 72 hours following hospital discharge)

Related Shortages

• Aztreonam Injection
• Carbenicillin Indanyl Capsules— No Longer Available
• Cefaclor
• Cefazolin Injection— Resolved
• Cefepime Injection— Resolved
• Cefotetan Disodium— Resolved
• Cefotetan Injection— Resolved
• Cefoxitin Injection— Resolved
• Ceftizoxime Injection— Resolved
• Cefuroxime Injection— Resolved
• Ciprofloxacin Immediate-Release Tablets
• Doxycycline Hyclate Injection
• Erythromycin Lactobionate Injection
• Imipenem and Cilastatin Injection— Resolved
• Kanamycin— Resolved
• Kanamycin Sulfate Injection
• Loracarbef Oral Tablets and Suspension— No Longer Available
• Minocycline Injection— No Longer Available
• Nafcillin Injection— Resolved
• Oxacillin Injection— Resolved
• Penicillin G Benzathine Injection— Resolved
• Penicillin G Procaine Suspension for Injection— Resolved
• Piperacillin and Tazobactam Injection— Resolved
• Polymyxin B Injection— Resolved
• Ticarcillin and Clavulanate Injection— Resolved
• Tigecycline Injection— Resolved
• Tobramycin Powder for Injection
• Vancomycin Hydrochloride Injection

1. Akorn (personal communication). August 10, 2009.
2. Consolidated Midlands (personal communication). August 10, 2009.
3. Fougera (personal communication). August 10, 2009.
4. Fera (personal communication). August 10, and October 2, 2009.
5. Bausch and Lomb (personal communication) August 10, 17, 25, and 31, and October 2, 2009.
6. Ocusoft (personal communication) August 10, 25, and 31, 2009.
7. Wilson (personal communication) August 10, 25, and 31, 2009.
8. Erythromycin 0.5% Ophthalmic Ointment. Product information. Tampa, FL: Bausch & Lomb Inc.; 2007 February.
9. Centers for Disease Control and Prevention (CDC). CDC Guidance on Shortage of Erythromycin (0.5%) Ophthalmic Ointment – September 2009. Accessed November 9, 2009.
10. Antimicrobial prophylaxis. In: Pickering LK, ed. 2009 Red Book: Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:827-829.
11. Barnes SD, Pavan-Lavangston D, Azar DT. Microbial Conjunctivitis. In: Mandel GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Philadelphia, PA: Elsevier; 2005:1387-1394.
12. Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag MS, eds. The Sanford Guide to Antimicrobial Therapy 2009. 39th ed. Sperryville, VA: Antimicrobial Therapy, Inc; 2009.
13. Wyatt BK. Unit dose packaging for ophthalmic ointments. Am J Hosp Pharm. Apr 1984;41(4):654-655.
14. Erythroymic. In: Trissel LA, ed. Trissel's Stability of Compounded Formulations. Washington, DC: American Pharmacists Association; 2005: 162-164.
15. Institute for Safe Medication Practices. Safety Briefs, Drug Shortage Causes Error. ISMP Medication Safety Alert! November 5, 2009.
16. AzaSite Ophthalmic Solution. Patient Dosing Instructions. Accessed November 9, 2009.
17. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Diseases Treatment Guidelines.-2006. MMWR Morb Mortal Wkly Rep. 2006 Aug 4;55(RR11):1-94. Accessed November 9, 2009.

Updated

Updated on November 10, 2009, Michelle Wheeler, Pharm.D., Drug Information Specialist, Drug Information Service. Created August 28, 2009 by Michelle Wheeler, Pharm.D., Drug Information Specialist and Erin R. Fox, Pharm.D., Manager, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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