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3/23/2020

Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution

Products Affected - Description

    • Dorzolamide and Timolol ophthalmic solution, Akorn, 22.3 mg-6.8 mg/mL, 10 mL bottle, 1 count, NDC 50383-0233-10
    • Dorzolamide and Timolol ophthalmic solution, Bausch Health, 22.3 mg-6.8 mg/mL, 10 mL bottle, 1 count, NDC 24208-0486-10
    • Dorzolamide and Timolol ophthalmic solution, Sandoz, 22.3 mg-6.8 mg/mL, 10 mL bottle, 1 count, NDC 61314-0030-02

Reason for the Shortage

    • Akorn has dorzolamide and timolol ophthalmic solution available.
    • Sandoz did not provide a reason for the shortage.
    • Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018.
    • Bausch Health had dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.

Available Products

    • Cosopt ophthalmic solution, Akorn, 22.3 mg-6.8 mg/mL, 10 mL Ocumeter Plus bottle, 1 count, NDC 17478-0605-10
    • Cosopt PF ophthalmic solution, Akorn, 22.3 mg-6.8 mg/mL, 0.2 mL single-use preservative-free vial, 60 count, NDC 17478-0604-30

Estimated Resupply Dates

    • Akorn has dorzolamide/timolol 2%/0.5% ophthalmic solution in 10 mL bottles on allocation.
    • Bausch Health has dorzolamide/timolol 2%/0.5% ophthalmic solution in 10 mL bottles on back order and the company estimates a release date of late-March to early-April 2020.
    • Sandoz has dorzolamide/timolol 2%/0.5% ophthalmic solution in 10 mL bottles on back order and the company estimates a release date of late-March 2020.

Implications for Patient Care

    • Each product contains dorzolamide hydrochloride 22.3 mg/mL (equivalent to dorzolamide 2%) and timolol maleate 6.8 mg/mL (equivalent to timolol 0.5%).

Updated

Updated March 23, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 30, 2017 by Benjamin Witt, PharmD, BCPS, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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