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Phenylephrine 2.5% and 10% Ophthalmic Solution

[08 October 2014]

Products Affected - Description

Phenylephrine Hydrochloride, Alcon/Sandoz
2.5%, 3 mL (NDC 61314-0342-01) - discontinued
2.5%, 5 mL (NDC 61314-0342-02) - discontinued

Phenylephrine Hydrochloride, Akorn
2.5%, 2 mL (NDC 17478-0200-20) - discontinued
2.5%, 15 mL (NDC 17478-0200-12) - discontinued
10%, 5 mL (NDC 17478-0205-10) - discontinued

Mydfrin, Alcon
2.5%, 5 mL (NDC 00998-0342-05) - discontinued
2.5%, 3 mL (NDC 00065-0342-03) - discontinued
 
Phenylephrine Hydrochloride, Paragon BioTeck (distributed by Bausch & Lomb, a Division of Valeant)
2.5% 15 mL (NDC 42702-0102-15)
10% 5 mL (NDC 42702-0103-05)

Reason for the Shortage

  • Akorn stopped manufacturing phenylephrine ophthalmic solution in April 2014 and stopped distributing product on June 30, 2014.1
  • Alcon discontinued phenylephrine 2.5% ophthalmic solution with the Sandoz label in April 2014.2
  • Alcon discontinued Mydfrin 2.5% ophthalmic solution in 2014.2
  • Hub discontinued phenylephrine 2.5% and 10% ophthalmic solution in 2013.3
  • Phenylephrine 2.5% and 10% from Paragon BioTeck is the only FDA-approved phenylephrine ophthalmic product. Paragon BioTeck supplies phenylephrine ophthalmic solution 2.5% and 10% and this is distributed by Bausch & Lomb (a division of Valeant).4,5

Available Products

There are insufficient supplies for usual ordering.

Estimated Resupply Dates

Valeant has phenylephrine 2.5% 15 mL bottles and phenylephrine 10% 5 mL bottles on intermittent back order and is allocating product as it is released.5

Implications for Patient Care

Phenylephrine hydrochloride is an alpha-1 adrenergic receptor agonist supplied as an ophthalmic solution and labeled for dilation of the pupil in adult and pediatric patients.6 Phenylephrine hydrochloride is used to induce mydriasis for routine ophthalmologic examinations and surgical procedures, as adjunctive treatment of anterior uveitis, and for symptomatic relief of postoperative inflammation.7

Safety

  • Phenylephrine ophthalmic solution from Paragon BioTeck should be refrigerated (2° to 8°C).6 However, stability studies were conducted at room temperature (23° to 27°C) and product was stable for up to 6 months. This product should not be adversely affected if inadvertently left at room temperature for brief periods.7
  • Do not use phenylephrine solution if it is brown-colored or contains a precipitate. This product contains 0.01% benzalkonium chloride as a preservative.6

Alternative Agents & Management

  • Phenylephrine hydrochloride is the only marketed topical sympathomimetic mydriatic agent. Other topical antimuscarinic mydriatic agents include atropine sulfate, cyclopentolate, homatropine, scopolamine hydrobromide, and tropicamide.8,9
  • Phenylephrine hydrochloride is also available in combination with cyclopentolate (Cyclomydril), and this product is labeled for the production of mydriasis.9 However, Cyclomydril has been on intermittent shortage as well.2

Related Shortages

References

  1. Akorn (personal communications). May 14 and June 30, 2014.
  2. Alcon (personal communications). May 14, June 30, and July 11, 2014.
  3. Hub Pharmaceuticals (personal communications). May 22, 2014.
  4. Paragon BioTeck (personal communications). May 14 and June 30, 2014.
  5. Valeant (personal communications). July 10 and 30, August 14, and October 8, 2014.
  6. Phenylephrine hydrochloride Ophthalmic Solution [product information]. Tigard, OR: Paragon BioTeck, 2013. Available online.
  7. Paragon BioTeck (written communication from May 21, 2014). Acquired July 11, 2014.
  8. Anon. Drug Evaluation: Phenylephrine. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2014. Updated periodically.
  9. Wickersham RM, Novak KK, managing eds., editors. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2014.

Updated

Updated October 8, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created July 11, 2014, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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