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warnings and cautions
5 WARNINGS AND PRECAUTIONS To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) LASTACAFT™ should not be used to treat contact lens-related irritation. ( 5.2 ) Remove contact lenses prior to instillation of LASTACAFT™ . ( 5.2 ) 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. 5.2 Contact Lens Use Patients should be advised not to wear a contact lens if their eye is red. LASTACAFT™ should not be used to treat contact lens-related irritation. LASTACAFT™ should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of LASTACAFT™ . The preservative in LASTACAFT™ , benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT™ . 5.3 Topical Ophthalmic Use Only LASTACAFT™ is for topical ophthalmic use only.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common ocular adverse reactions, occurring in < 4% of LASTACAFT™ -treated eyes, were eye irritation, burning and/or stinging on instillation, eye redness, and eye pruritus. ( 6.1 ) The most common non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT™- treated eyes, were nasopharyngitis, headache and influenza. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Adverse Reactions The most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT™ -treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus. 6.2 Non-ocular Adverse Reactions The most frequent non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT™ -treated eyes, were nasopharyngitis, headache and influenza. Some of these events were similar to the underlying disease being studied.