BEXALOL

Dosage Form & Composition

Eye drop: Each mL contains Active: 0.56% Betaxolol HCl (0.5% Betaxolol as base). Preservative: Benzalkonium Chloride 0.01%. Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), and purified water.

Pack Size: In 5 mL white opaque plastic ophthalmic Droptainer Dispensers.

Indications

Bexalol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of:

Patients with chronic open-angle glaucoma;

Patients with elevated intraocular pressure (ocular hypersensitive patients);

Patients with glaucoma or ocular hypertension who have reactive airway disease;

Patients with glaucoma or ocular hypertension who are currently on multiple anti-glaucoma therapy.

Contra-indications

Hypersensitivity to any component of this product. Bexalol Ophthalmic Solution is contraindicated in patients with sinus bradycardia greater than a first degree atrioventricular block, cardiogenic shock, or patients with a history of overt cardiac failure.

Dosage & Administration

The usual dose is one drop of Bexalol Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering response to Bexalol Ophthalmic Solution may require a few weeks to stabilize.

Clinical follow up should include a determination of the intraocular pressure during the first month of treatment with Bexalol Ophthalmic Solution. Thereafter, intraocular pressures should be determined on an individual basis at the judgement of the physician.

When a patient is transferred from a single anti-glaucoma agent, continue the agent already used and add drop Bexalol Ophthalmic Solution in the affected eye(s) twice a day.

On the following day, discontinue the previous anti-glaucoma agent completely and continue with Bexalol Ophthalmic Solution. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine, other miotics, epinephrine or systemically administered carbonic anhydrase inhibitors can be instituted.

When a patient is transferred from several concomitantly administered anti-glaucoma agents, individualization is required. Adjustment should involve one agent at a time made at intervals of not less than one week.