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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 ) Epinastine hydrochloride ophthalmic solution should not be used to treat contact lens-related irritation. ( 5.2 ) Remove contact lenses prior to instillation of epinastine hydrochloride ophthalmic solution. ( 5.2 ) 5.1 Contamination of Tip and Solution Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Bottle should be kept tightly closed when not in use. 5.2 Use with Contact Lenses Patients should be advised not to wear a contact lens if their eye is red. Epinastine hydrochloride ophthalmic solution should not be used to treat contact lens-related irritation. The preservative in epinastine hydrochloride ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of epinastine hydrochloride ophthalmic solution and may be reinserted after 10 minutes following its administration. 5.3 Topical Ophthalmic Use Only Epinastine hydrochloride ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.
6 ADVERSE REACTIONS The most common ocular adverse reactions (incidence occurring in approximately 1% to 10% of epinastine hydrochloride ophthalmic solution treated eyes were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most common non-ocular adverse reactions, occurring in 10% of epinastine hydrochloride ophthalmic solution-treated eyes, were infection (cold symptoms and upper respiratory infections). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse reactions occurring in approximately 1 to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 to 3% of patients. Some of these reactions were similar to the underlying disease being studied. 6.2 Postmarketing Experience The following reactions have been identified during postmarketing use of epinastine hydrochloride ophthalmic solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to epinastine hydrochloride ophthalmic solution, or a combination of these factors, include: lacrimation increased.