betaxolol hydrochloride
betaxolol hydrochloride is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including BETAXOLOL HYDROCHLORIDE, Betoptic S. Available dosage forms: tablet, coated, suspension/ drops.
Drug Details
- Generic Name
- betaxolol hydrochloride
- Brand Names
- BETAXOLOL HYDROCHLORIDE, Betoptic S
- Application Number
- ANDA078962
- Sponsor
- KVK-TECH, INC.
- NDC Codes
- 3
- Dosage Forms
- TABLET, COATED, SUSPENSION/ DROPS
- Routes
- ORAL, OPHTHALMIC
- Active Ingredients
- BETAXOLOL HYDROCHLORIDE
Indications and 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.
Warnings
WARNING Topically applied beta-adrenergic blocking agents may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents. Betaxolol Hydrochloride Ophthalmic Solution has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betaxolol Hydrochloride Ophthalmic Solution should be discontinued at the first signs of cardiac failure.