Betoptic S
Generic: BETAXOLOL HYDROCHLORIDE
Basic Information
Manufacturer
Novartis Pharmaceuticals Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
905ba189-456c-4aa4-8231-39a971374ad8
Indications & Usage
1 INDICATIONS AND USAGE BETOPTIC S ® (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
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BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
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Adverse Reactions
6 ADVERSE REACTIONS The most frequent adverse reaction is transient ocular discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S has been transient ocular discomfort.
The following other adverse reactions have been reported in small numbers of patients: Ocular: blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity, and crusty lashes.
Systemic Adverse Reactions Include : Cardiovascular: Bradycardia, heart block, and congestive failure.
Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma, and respiratory failure.
Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs, and symptoms of myasthenia gravis.
Other: Hives, toxic epidermal necrolysis, hair loss and glossitis.
Perversions of taste and smell have been reported.
In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S was comparable to that seen in adult patients.
6.2 Additional Potential Adverse Reactions Associated With Betaxolol Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formation, edema, and anisocoria.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S has been transient ocular discomfort.
The following other adverse reactions have been reported in small numbers of patients: Ocular: blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity, and crusty lashes.
Systemic Adverse Reactions Include : Cardiovascular: Bradycardia, heart block, and congestive failure.
Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma, and respiratory failure.
Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs, and symptoms of myasthenia gravis.
Other: Hives, toxic epidermal necrolysis, hair loss and glossitis.
Perversions of taste and smell have been reported.
In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S was comparable to that seen in adult patients.
6.2 Additional Potential Adverse Reactions Associated With Betaxolol Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formation, edema, and anisocoria.