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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.
Ocular: In clinical trials, the most frequent event associated with the use of BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.5% has been transient ocular discomfort upon instillation (11%). Transient blurred vision has been reported in approximately 2% of patients. Other ocular events have been reported in less than 2% of patients and include: cataracts, and vitreous disorders.
Systemic: Systemic reactions following administration of BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.5% and other topical ocular formations of betaxolol have been at an incidence of less than 2%. These include:
Digestive: Constipation and dyspepsia.
Musculoskeletal: Arthritis and tendonitis.
Other: Accidental injury, headache, and infection.
In a three-month, multi-center, double-masked, active-controlled trial in pediatric patients, the adverse event profile of BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension was comparable to that seen in adult and elderly patients.
Read the Betaxon (levobetaxolol hydrochloride ophthalmic suspension) Side Effects Center for a complete guide to possible side effects
Oral Beta-Adrenergic Receptor Blocking Agents
Patients who are receiving a beta-adrenergic blocking agent orally and BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 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 blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia.
Concomitant Adrenergic Psychotropic Drugs
Levobetaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/30/2010
Additional Betaxon Information
Report Problems to the Food and Drug Administration
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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