Friday, September 13, 2013


flff fl I III H I I I I I I 
(Betaxolol Hydrochloride) 
Sterile Ophthalmic Solution 
contains Betaxolol Hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, ins preserved, sterile isotonic solution. Each ml contains: Active: 0.56% Betaxolol Hydrochloride (0.5% Betaxolol as base). 
Preservative: Benzalkonium Chloride 0.01%. 
macfives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), and Purified 
CLINICAL PHARMACOLOGY: Betaxolol HCI, a cardioselective (beta-i -adrenergic) receptor blocking agent, does not have significant membrane-stabilizing (local anestefic) activity and is devoid of intrinsic sympathomimetic action. 
When instilled in the eye, BETOPTIC OPHTHALMIC SOLUTION has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. 
In three-way masked crossover studies comparing ophthalmic betaxolol to timolol and placebo, BETOPTIC OPHTHALMIC SOLUTION was found to have minimal effect on pulmonary and cardiovascular parameters. In contrast, fimolol significantly decreased pulmonary function and produced a lowering of the mean heart rate. 
CLINICAL STUDIES: BETOPTIC OPHTHALMIC SOLUTION has been used succesfully in glaucoma patients who have undergone a laser trabeculoplasty and have needed additional long-term hypotensive therapy. BETOPTIC OPHTHALMIC SOLUTION has also been well tolerated in glaucoma patients wearing hard or soft contact lenses and in aphakic patients. 
BETOPTIC OPHTHALMIC SOLUTION does not produce miosis or accommodative spasm, as frequently seen with miotic agents. The blurred vision and night blindness often associated wit h standard miotic therapy are not associated with ophthalmic betaxolol. Thus, patients with central lenticular opacities avoid the visual impairment caused by a constricted pupil. 
INDICATIONS AND USAGE: BETOPTIC OPHTHALMIC SOLUTION has been shown to be effective in lowering intraocular pressure and is indicated in 
the treatment of: 
1. Patients with chronic open-angle glaucoma. 
2. Patients wit h elevated intraocular pressure (ocular hypersensitive patients). 
3. Patients with glaucoma or ocular hypertension who have reactive airway disease. 
4. Patients with glaucoma or ocular hypertension who are currently on multiple-antiglaucoma therapy. 
CONTRAINDICATIONS: Hypersensitivity to any component of this product. BETOPTIC OPHTHALMIC SOLUTION is confraindicated in patients with sinus bradycardiagreaterthan a firstdegree atrioventricular block, cardiogenic shock, orpatientswith a history of overt cardiac failure. PRECAUTIONS: Patients who are receiving a beta-adrenergic blocking agent Orally and BETOPTIC OPHTHALMIC SOLUTION should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade. 
While BETOPTIC OPHTHALMIC SOLUTION has demonstrated a low potential for systemic effects, it should be used with caution in patients with diabetes (especially labile diabetes) or in patients suspected of developing thyrotoxicosis. Consideration should be given to the gradual withdrawal of beta-adrenergic blocking agent prior to general anesthesia because of the reduced ability of the heart to respond to beta-adrenergically medicated sympathetic reflex stimuli. 
1096 34453-6

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