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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
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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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