Products Affected - Description
Phenylephrine Ophthalmic Solution
Reason for the Shortage
- Akorn received FDA approval of phenylephrine ophthalmic solution in January 2015 and has product available.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 was the first 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
2.5% 2 mL (NDC 17478-0201-02)
2.5% 15 mL (NDC 17478-0201-15)
10% 5 mL (NDC 17478-0206-05)
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)
Estimated Resupply Dates
All presentations are currently available.1
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
- 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
- Akorn (personal communications). May 14, June 30, 2014; and January 26, March 2, 16, and 23, and April 20, 2015.
- Alcon (personal communications). May 14, June 30, and July 11, 2014.
- Hub Pharmaceuticals (personal communications). May 22, 2014.
- Paragon BioTeck (personal communications). May 14 and June 30, 2014; March 2, 2015.
- Valeant (personal communications). July 10 and 30, August 14, October 8, and November 26, 2014; and January 12 and April 21, 2015.
- Phenylephrine hydrochloride Ophthalmic Solution [product information]. Tigard, OR: Paragon BioTeck, 2013. Available online.
- Paragon BioTeck (written communication from May 21, 2014). Acquired July 11, 2014.
- Anon. Drug Evaluation: Phenylephrine. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2014. Updated periodically.
- Wickersham RM, Novak KK, managing eds., editors. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2014.
Updated April 21, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Created July 11, 2014, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.
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