Betaxolol Hydrochloride
Generic Name: betaxolol hydrochloride
Brand Names:
Betoptic S
11 DESCRIPTION BETOPTIC S contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89 g/mol. 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.
Overview
11 DESCRIPTION BETOPTIC S contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89 g/mol. 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.
Uses
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. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Instill one drop of BETOPTIC S in the affected eye(s) twice daily. Shake well before using. BETOPTIC S may be used alone or in combination with other IOP lowering medications. Advise patients requiring concomitant topical ophthalmic medications to administer these at least 10 minutes before instilling BETOPTIC S. Instill one drop in the affected eye(s) twice daily. ( 2 )
Side Effects
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.
Interactions
7 DRUG INTERACTIONS Oral beta-adrenergic receptor inhibitors may have additive effects. (7.1 ) Catecholamine-depleting drugs may have additive effects. ( 7.2 ) Concomitant adrenergic psychotropic drugs may have additive effects. ( 7.3 ) 7.1 Oral Beta-Adrenergic Receptor Inhibitors Patients who are receiving a beta-adrenergic receptor inhibitor orally and BETOPTIC S should be observed for a potential additive effect either on the IOP or on the known systemic effects of beta blockade.
Warnings
5 WARNINGS AND PRECAUTIONS Systemic Absorption : Same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical ophthalmic administration. ( 5.1 ) Cardiac Failure : Discontinue treatment at the first signs of cardiac failure. ( 5.2 ) Diabetes Mellitus : Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia. Administer with caution in diabetic patients subject to hypoglycemia. ( 5.3 ) Thyrotoxicosis : Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia) or hyperthyroidism. ( 5.4 ) 5.1 Systemic Absorption As with many topically applied ophthalmic drugs, this drug is absorbed systemically. 4 CONTRAINDICATIONS BETOPTIC S is contraindicated in patients with: sinus bradycardia greater than a first degree atrioventricular (AV) block cardiogenic shock patients with overt cardiac failure hypersensitivity to any component of this product Hypersensitivity to any component of this product.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of BETOPTIC S administration in pregnant women to inform a drug-associated risk. There are limited data with the use of betaxolol eye drops in pregnant women. Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth retardation when beta-blockers are administered by the oral route. In animal reproductive studies, no drug-induced maternal toxicity or teratogenicity was observed at clinically relevant doses (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING BETOPTIC S (betaxolol hydrochloride ophthalmic suspension), 0.25% is supplied as follows: 10 mL and 15 mL in plastic ophthalmic dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 10 mL NDC 0078-0729-10 15 mL NDC 0078-0729-15 Storage and Handling Store upright at 2°C to 25°C (36°F to 77°F).
Frequently Asked Questions
What is Betaxolol Hydrochloride used for?▼
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. ( 1 )
What are the side effects of Betaxolol Hydrochloride?▼
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.
Can I take Betaxolol Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of BETOPTIC S administration in pregnant women to inform a drug-associated risk. There are limited data with the use of betaxolol eye drops in pregnant women. Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth retardation when beta-blockers are administered by the oral route. In animal reproductive studies, no drug-induced maternal toxicity or teratogenicity was observed at clinically relevant doses (see Data) .
What are the important warnings for Betaxolol Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS Systemic Absorption : Same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical ophthalmic administration. ( 5.1 ) Cardiac Failure : Discontinue treatment at the first signs of cardiac failure. ( 5.2 ) Diabetes Mellitus : Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia. Administer with caution in diabetic patients subject to hypoglycemia. ( 5.3 ) Thyrotoxicosis : Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia) or hyperthyroidism. ( 5.4 ) 5.1 Systemic Absorption As with many topically applied ophthalmic drugs, this drug is absorbed systemically. 4 CONTRAINDICATIONS BETOPTIC S is contraindicated in patients with: sinus bradycardia greater than a first degree atrioventricular (AV) block cardiogenic shock patients with overt cardiac failure hypersensitivity to any component of this product Hypersensitivity to any component of this product.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.