Betaxon (Levobetaxolol Hydrochloride Ophthalmic Suspension) Drug Information: Side Effects and Drug Interactions

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May 25, 2012

Betaxon

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Glaucoma is a disease of the major nerve of vision, called the optic nerve. The optic nerve receives light-generated nerve impulses from the retina and transmits these to the brain, where we recognize those electrical signals as vision. Glaucoma is characterized by a particular pattern of progressive damage to the optic nerve that generally begins with a subtle loss of side vision (peripheral vision). If glaucoma is not diagnosed and treated, it can progress to loss of central vision and blindness.

Glaucoma is usually, but not always, associated with elevated pressure in the eye (intraocular pressure). Generally, it is this elevated eye pressure that leads to damage of the eye (optic) nerve. In some cases, glaucoma may occur in the presence of normal eye pressure. This form of glaucoma is believed to be caused by poor regulation of blood flow to the optic nerve.

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Worldwide, glaucoma...

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Betaxon

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SIDE EFFECTS

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:

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.

Musculoskeletal: 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.

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.

DRUG INTERACTIONS

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.

Catecholamine-Depleting Drugs

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.