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warnings and cautions
5 WARNINGS AND PRECAUTIONS For Topical Ophthalmic Use: Not for Injection. ( 5.1 ) Corneal Opacification: Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. ( 5.2 ) For Administration by Healthcare Provider: AKTEN ® is not intended for patient self-administration. ( 5.3 ) 5.1 For Topical Ophthalmic Use AKTEN ® is indicated for topical ophthalmic use. Not for Injection. 5.2 Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. 5.3 For Administration by Healthcare Provider AKTEN ® is indicated for administration under the direct supervision of a healthcare provider. AKTEN ® is not intended for patient self-administration.
6 ADVERSE REACTIONS Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Akorn Operating Company LLC at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .