Disclaimer
The information provided in this report is intended solely for educational and professional reference purposes and is not a substitute for medical advice, diagnosis, or treatment. Clinical decisions must always be based on the official prescribing information approved by regulatory authorities and the judgment of qualified healthcare professionals.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
Summary
BETOPTIC® 5 mg/mL Eye Drops (0.5%) is an ophthalmic antiglaucoma medication containing betaxolol hydrochloride, a selective β1-adrenergic receptor blocker. It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
Betaxolol lowers IOP primarily by reducing aqueous humor production without causing miosis or accommodative spasm. Due to its β1 selectivity, it demonstrates less pulmonary and cardiovascular impact compared with non-selective beta-blockers, although systemic absorption and systemic effects may still occur in susceptible patients. BETOPTIC® may be used as monotherapy or as adjunctive therapy with other antiglaucoma agents.
Brand Name
BETOPTIC®
Category
Ophthalmic anti-glaucoma agent
Ocular anti-hypertensive
Beta-adrenergic receptor blocker
Selective β1-blocker
Active Ingredient
Betaxolol Hydrochloride
Pharmaceutical Form & Strength
Sterile ophthalmic solution (eye drops)
Strength: 5 mg/mL betaxolol (as base)
Equivalent to 0.56% betaxolol hydrochloride
Pack size: 5 mL multidose ophthalmic bottle
Preservative: Benzalkonium chloride
Excipients: Disodium edetate, sodium chloride, hydrochloric acid and/or sodium hydroxide (for pH adjustment), purified water.
Manufacturer & Marketing Authorization Holder
Original developer / manufacturer: Alcon Laboratories, Inc.
Manufacturing site (historical): Alcon-Couvreur NV, Belgium
Global product ownership / scientific oversight: Alcon (formerly under Novartis Group)
Scientific Office: Novartis Scientific Office (historical reference)
Local manufacturer, marketing authorization holder, or distributor may vary by country and must be verified with the national regulatory authority.
Mechanism of Action
Betaxolol is a cardioselective β1-adrenergic receptor antagonist. Following topical ocular administration, it blocks β1 receptors in the ciliary epithelium, resulting in:
Decreased aqueous humor production
Reduction of intraocular pressure
Betaxolol has no intrinsic sympathomimetic activity, no significant membrane-stabilizing (local anesthetic) activity, and does not affect pupil size or accommodation.
Spectrum of Activity
Ocular hypotensive activity only
No miotic effect
No antimicrobial, anti-inflammatory, or anesthetic action
Pharmacokinetics
Onset of action: ~30 minutes
Peak effect: 2–4 hours
Duration of action: Up to 12 hours
Systemic absorption: Occurs after topical administration; usually limited but may be clinically relevant in susceptible patients
Metabolism (systemic): Hepatic
Elimination: Primarily renal
Indications
BETOPTIC® is indicated for the reduction of elevated intraocular pressure in:
Chronic open-angle glaucoma
Ocular hypertension
It may be used alone or in combination with other antiglaucoma agents, including miotics or carbonic anhydrase inhibitors.
Administration
Recommended dose:
One to two drops in the affected eye(s) twice dailyIntraocular pressure should be monitored during initiation and periodically thereafter
When transferring from another antiglaucoma agent, overlap therapy may be required for one day, followed by discontinuation of the previous agent
Allow at least 10 minutes between different ophthalmic medications
Method of Preparation
Ready-to-use sterile ophthalmic solution
No dilution or reconstitution required
Avoid contamination of the dropper tip
For ophthalmic use only
Contraindications
Hypersensitivity to betaxolol or any component of the formulation
Sinus bradycardia
Second- or third-degree atrioventricular block
Cardiogenic shock
Overt or uncontrolled cardiac failure
Warnings & Precautions
Systemic absorption of topical beta-blockers may occur
Use with caution in patients with:
Diabetes mellitus (may mask hypoglycemia symptoms)
Thyrotoxicosis (may mask clinical signs)
Reactive airway disease or reduced pulmonary reserve
Peripheral vascular disease
Gradual withdrawal should be considered prior to major surgery under general anesthesia
In angle-closure glaucoma, BETOPTIC® must be used with a miotic agent
Benzalkonium chloride may be absorbed by soft contact lenses; lenses should be removed prior to instillation
Drug Interactions
Oral beta-blockers (additive systemic beta-blockade)
Catecholamine-depleting drugs (e.g., reserpine) → risk of hypotension and bradycardia
Calcium channel blockers (e.g., verapamil, diltiazem) → increased risk of cardiac depression
Digitalis glycosides → enhanced bradycardia risk
Epinephrine → rare cases of mydriasis reported
Side Effects
Ocular Adverse Effects
Common:
Transient burning or stinging upon instillation
Ocular discomfort
Tearing
Temporary blurred vision
Less Common:
Dry eye
Erythema
Pruritus
Foreign body sensation
Rare but Reported:
Decreased corneal sensitivity
Corneal punctate staining
Keratitis
Photophobia
Anisocoria
Systemic Adverse Effects (rare with topical use)
Bradycardia
Hypotension
Fatigue
Dizziness or vertigo
Headache
Insomnia
Depressive symptoms
Dyspnea or bronchospasm (less frequent than with non-selective beta-blockers)
Use in Special Populations
Pregnancy: Pregnancy Category C – use only if potential benefit justifies potential risk
Lactation: Use with caution; monitor infant for signs of beta-blockade
Pediatrics: Safety and efficacy have not been established
Geriatrics: No specific dose adjustment required; monitor for systemic effects
Renal/Hepatic impairment: No routine dose adjustment required
Storage Conditions
Store at room temperature (15–25°C)
Protect from light and freezing
Keep out of reach of children
Discard the bottle 4 weeks after first opening (common clinical practice)
Additional Sections
Effect on vision: Temporary blurred vision may occur after instillation; patients should wait until vision clears before driving or operating machinery
Long-term therapy: Reduced responsiveness has been reported in some patients; periodic IOP monitoring is recommended
Overdose: Flush the eye with water; systemic effects should be managed supportively
Frequently Asked Questions (FAQ)
Does BETOPTIC® cause pupil constriction or night vision problems?
No, it does not cause miosis or accommodative spasm.
Is BETOPTIC® safer for patients with asthma?
It is relatively safer than non-selective beta-blockers due to β1 selectivity, but caution is still required.
How often should BETOPTIC® be used?
Typically one to two drops twice daily, unless otherwise directed by an ophthalmologist.
Can it be used with contact lenses?
Yes, but contact lenses should be removed before instillation and reinserted after at least 15 minutes.
References
FDA / DailyMed: Betaxolol Hydrochloride Ophthalmic Solution (0.5%)
Alcon Product Monograph – BETOPTIC®
AHFS Drug Information
Medscape Drug Reference: Betaxolol Ophthalmic
European Glaucoma Society Guidelines
Comments
Post a Comment