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As with other topically applied ophthalmic drugs, levobunolol may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Keep out of reach of children. For external use only. Do not touch dropper tip to any surface, since this may contaminate the solution. Protect from light and excessive heat. Discard any unused solution after end of treatment period.
Transient burning, stinging or itching, blepharoconjunctivitis and decreases in heart rate and blood pressure have been reported occasionally with the use of levobunolol. Iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria and pruritus have been reported rarely. Decreased corneal sensitivity has been noted in a small number of patients. The following additional adverse reactions have been reported with ophthalmic use of beta1 and beta2 (nonselective) adrenergic receptor blocking agents:
Body as a whole
headache.
Cardiovascular
arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation.
Digestive
nausea.
Psychiatric
depression.
Integumentary
hypersensitivity, including localized and generalized rash.
Respiratory
bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure.
Endocrine
masked symptoms of hypoglycemia in insulin-dependent diabetics.
Special Senses
signs and symptoms of keratitis, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis.
Other reactions associated with the oral use of nonselective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.
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