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Clinical Studies Experience
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 practice.
In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients:
Ocular: blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes.
In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.
Additional Potential Adverse Reactions Associated with Betaxolol
Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formations, edema and anisocoria.
Read the Betoptic S (betaxolol hydrochloride ophthalmic suspension) Side Effects Center for a complete guide to possible side effects
Oral Beta-Adrenergic Receptor Inhibitors
Patients who are receiving a beta-adrenergic receptor inhibitor orally and BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade.
Close observation of the patient is recommended when a beta-adrenergic receptor inhibitor is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia which may result in vertigo, syncope, or postural hypotension.
Concomitant Adrenergic Psychotropic Drugs
Betaxolol is an adrenergic receptor inhibitor; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.
Read the Betoptic S Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Betoptic S Information
Betoptic S - User Reviews
Betoptic S User Reviews
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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