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Betaxon

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Betaxon

Betaxon

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.

Read the Betaxon (levobetaxolol hydrochloride ophthalmic suspension) Side Effects Center for a complete guide to possible side effects

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.

Concomitant Adrenergic Psychotropic Drugs

Levobetaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

Last reviewed on RxList: 3/30/2010
This monograph has been modified to include the generic and brand name in many instances.

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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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