OphthalmIc solutIon has been shown to be effectIve In lowerIng Intraocular pressure and may be used In patIents wIth chronIc open-angle glaucoma or ocular hypertensIon.
The recommended starting dose is one to two drops of it ophthalmic solution 0.5% in the affected eye(s) once a day. In patients with more severe or uncontrolled glaucoma, it 0.5% can be administered b.i.d. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of it 0.5% b.i.d. are not generally more effective. If the patient’s IOP is not at a satisfactory level on this regimen, concomitant therapy with other ophthalmic IOP-lowering agents can be instituted. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
It ophthalmic solution is contraindicated in those individuals with bronchial asthma, or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure cardiogenic shock; or hypersensitivity to any component of these products. As with other topically applied ophthalmic drugs, it may be absorbed systemically. The same adverse reactions found with systemic administration of betaadrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents. Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus.
Pregnancy Fetotoxicity (as evidenced by a greater number of resorption sites) has been observed in rabbits when doses of levobunolol HCl equivalent to 200 and 700 times the recommended dose for the treatment of glaucoma were given. No fetotoxic effects have been observed in similar studies with rats at up to 1,800 times the human dose for glaucoma. Teratogenic studies with levobunolol in rats at doses up to 25 mg/kg/day (1,800 times the recommended human dose for glaucoma) showed no evidence of fetal malformations. There were no adverse effects on postnatal development of offspring. It appears when results from studies using rats and studies with other beta-adrenergic blockers are examined, that the rabbit may be a particularly sensitive species. There are no adequate and well-controlled studies in pregnant women. it ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Systemic beta-blockers and topical timolol maleate are known to be excreted in human milk. Caution should be exercised when it is administered to a nursing woman.
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