Drug Catalog - Product Detail
BETAXOLOL HCL OPHTH. SOL. SOL 0.005 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0705-10 | AKORN | 5 | 0.5% | NA |
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Description
DESCRIPTION Betaxolol Ophthalmic Solution USP, contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.90. The structural formula is presented below: Molecular Formula: C 18 H 29 NO 3 •HCl Chemical Name: (±)-1[ p -[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; Preservative: Benzalkonium Chloride 0.01%. Structural Formula
How Supplied
HOW SUPPLIED Betaxolol Ophthalmic Solution 0.5% is a sterile, isotonic, aqueous solution of betaxolol hydrochloride, USP. Supplied as follows: 2.5 mL, 5 mL, 10 mL and 15 mL in plastic ophthalmic dropper tip bottles. NDC 17478-705-25 2.5 mL Bottle NDC 17478-705-10 5 mL Bottle NDC 17478-705-11 10 mL Bottle NDC 17478-705-12 15 mL Bottle Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactued by: Akorn, Inc. Lake Forest, IL 60045 BX00N Rev. 06/16
Indications & Usage
INDICATIONS AND USAGE Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dose is one to two drops of Betaxolol Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.