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Home » Directories » FDA Approved Drugs » Betaxon

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Betaxon

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Currently Enrolling Trials

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    General Information

    Betaxon (levobetaxolol hydrochloride suspension, drops) is an ophthalmic suspension which, when instilled in the eye, reduces intraocular pressure (IOP), a major risk factor in glaucomatous field loss. Elevated IOP accounts for greater likelihood of optic nerve damage and visual field loss. Most of the diseases of the eye which cause glaucoma are characterized by increased IOP.

    Currently, there is no cure for glaucoma. Furthermore, since there are no obvious symptoms, it is difficult to detect glaucoma before serious loss of sight is experienced. The best defense is to have regular eye exams. See below for a list of populations that are of higher risk for developing glaucoma.

    Clinical Results

    In two clinical research studies in which a total of 365 patients were dosed for three months with the study drug, Betaxon was shown to significantly reduce IOP at all follow up visits.

    Side Effects

    The main adverse effects experienced by patients in clinical trials included:

    • Discomfort of the eye upon treatment
    • Blurred vision
    • Cataracts and vitreous disorders (experienced by less than 2% of the patients)

    In addition, the same adverse reactions that may occur with systemic beta-adrenergic blocking agents may result from this topically applied beta-adrenergic blocking agent. These effects may include:

    • Severe respiratory reactions
    • Severe cardiac reactions

    Betaxon is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with over cardiac failure.

    Results of clinical research indicate that this drug may have a minor effect on heart rate and blood pressure.

    Mechanism of Action

    Since racemic betaxolol and other beta-adrenergic antagonists have been shown to reduce intraocular pressure by a reduction of aqueous production as demonstrated by tonography and aqueous flourophotometry, it is assumed that the mechanism of action of levobetaxolol is similar. The intraocular lowering effect of racemic betaxolol can generally be noted within 30 minutes and the maximal effect can usually be detected two hours after topical administration. It is assumed that the intraocular lowering time profile of levobetaxolol is similar. A single dose provides approximately a 12-hour reduction in intraocular pressure. (FDA Label)

    Literature References

    To learn more about the eye disorder, glaucoma, and research being done in this field, visit the Glaucoma Foundation web site: www.glaucoma-foundation.org

    Alcon Laboratories, Inc., the company that produces Betaxon, is an eyecare resource for both consumers and professionals. Visit the Alcon Labs web site: www.alconlabs.com

    Additional Information

    According to the Glaucoma Foundation, you may be at greater risk for developing the glaucoma if:

    • you are over 45 and have not had your eyes examined regularly
    • someone in your family has a history of glaucoma
    • you have abnormally high intraocular pressure
    • you are of African descent
    • you have diabetes
    • you are myopic (nearsighted)
    • you have had regular, long-term steroid/cortisone use
    • you have had previous eye injury
    Approval Date: 2000-02-01
    Date Created: 2000-03-13 12:00:00
    Company Name: Alcon
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