Drug Catalog - Product Detail
BETAXOLOL HCL OPHTH. SOL. SOL 0.005 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 61314-0245-01 | SANDOZ | 5 | 0.5% | NA |
PACKAGE FILES
Generic Name
BETAXOLOL HYDROCHLORIDE
Substance Name
BETAXOLOL HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
NDA019270
Description
DESCRIPTION Betaxolol Hydrochloride Ophthalmic Solution 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 343.89. The chemical structure is presented below: Empirical Formula: C 18 H 29 NO 3 •HCl Chemical Name: (±)-1-[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, purified water, sodium chloride, with hydrochloric acid and/or sodium hydroxide (to adjust pH). chemical
How Supplied
HOW SUPPLIED Betaxolol Hydrochloride Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 5, 10 and 15 mL in plastic ophthalmic dispensers. 5 mL: NDC 61314-245-01 15 mL: NDC 61314-245-02 10 mL: NDC 61314-245-03 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rev. May 2023 300059509-0523 Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540
Indications & Usage
INDICATIONS AND USAGE Betaxolol Hydrochloride 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 Hydrochloride 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 Hydrochloride Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol Hydrochloride Ophthalmic Solution 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.