Ocular:   In clinical trials, the most frequent event associated with the use of BETAXON™ 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. All other ocular events occurred one time at an incidence of less than 0.2%.

Systemic:   Systemic reactions following administration of BETAXON™ Ophthalmic Suspension 0.5% and other topical ocular formulations of betaxolol have been at an incidence of less than 2%.

These include:

Cardiovascular:   Bradycardia, heart block, hypertension, hypotension, tachycardia, and vascular anomaly.

Central Nervous System:   Anxiety, dizziness, hypertonia, and vertigo.

Digestive:   Constipation and dyspepsia.

Endocrine:   Diabetes and hypothyroidism.

Metabolic and Nutritional Disorders:   Gout, hypercholesteremia, and hyperlipidemia.

Musculoskelatal:   Arthritis and tendonitis.

Pulmonary:   Pulmonary distress characterized by bronchitis, dyspnea, pharyngitis, pneumonia, rhinitis, and sinusitis.

Skin and Appendages:   Alopecia, dermatitis, and psoriasis.

Special Senses:   Ear pain, otitis media, taste perversion, and tinnitus.

Urogenital:   Breast abscess and cystitis.

Other:   Accidental injury, headache, and infection.

Patients who are receiving a beta-adrenergic blocking agent orally and BETAXON™ 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. Levobetaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

Risk from anaphylactic reaction:   While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Ocular:   In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle by constriction of the pupil with a miotic agent. Racemic betaxolol has little or no effect on the pupil. It is expected that levobetaxolol will also have little or no effect on the pupil. When BETAXON™ Ophthalmic Suspension is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.

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