Betaxolol Ophthalmic

What is Betaxolol Ophthalmic?

• Betaxolol Ophthalmic (Betoptic; Betoptic S) is a beta-adrenergic receptor inhibitor used for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.

Betaxolol structure

Betaxolol ball-and-stick

What are the uses of this medicine?

• Betaxolol Ophthalmic (Betoptic; Betoptic S) is used for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.

How does this medicine work?

• Betaxolol HCl, a cardioselective (beta-1-adrenergic) receptor inhibitor, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action.
• When instilled in the eye, Betaxolol has the action of reducing elevated IOP, whether or not accompanied by glaucoma.
• Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.
• Elevated IOP presents a major risk factor in glaucomatous field loss.
• The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
• Betaxolol has the action of reducing elevated as well as normal IOP and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry.

Who Should Not Use this medicine ?

This medicine cannot be used 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

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the following:

• other eye medications
• beta blockers such as atenolol (Tenormin)
• carteolol (Cartrol)
• labetalol (Normodyne, Trandate)
• metoprolol (Lopressor)
• nadolol (Corgard)
• propranolol (Inderal)
• sotalol (Betapace)
• timolol (Blocadren)
• quinidine (Quinidex, Quinaglute Dura-Tabs)
• verapamil (Calan, Isoptin)
• vitamins

Is this medicine FDA approved?

• Betaxolol was approved for use in the United States in 1985.

How should this medicine be used?

Recommended dosage:

• Instill one drop of Betaxolol in the affected eye(s) twice daily.
• Betaxolol 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.

Administration:

• Ophthalmic betaxolol comes as a solution (liquid) and a suspension (liquid) to instill in the eyes.
• Ophthalmic betaxolol is usually used twice a day.
• Betaxolol eye drops control glaucoma but do not cure it.
• Continue to use betaxolol eye drops even if you feel well.
• Do not stop using betaxolol eye drops without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ophthalmic suspension: 2.5 mg/mL of betaxolol as base (0.25%)
• Betaxolol Ophthalmic Solution USP

This medicine is available in fallowing brand namesː

• Betoptic
• Betoptic S

What side effects can this medication cause?

The most common side effects of this medicine include:

• Eye Discomfort
• occasional tearing
• corneal sensitivity
• erythema
• itching sensation
• corneal punctate staining
• keratitis
• anisocoria
• edema
• photophobia
• blurred vision
• foreign body sensation
• dryness of the eyes
• inflammation
• discharge
• ocular pain
• decreased visual acuity
• crusty lashes

What special precautions should I follow?

• As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical administration.
• Betaxolol 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 should be discontinued at the first signs of cardiac failure.
• Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia. Beta-adrenergic receptor inhibitors should be administered with caution in patients subject to hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
• Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.
• Beta-adrenergic receptor inhibitors have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using betaxolol.
• If you are using another topical eye medication, instill it at least 10 minutes before you instill betaxolol.
• Caution should be exercised in the treatment of glaucoma patients with excessive restriction of pulmonary function. There have been reports of asthmatic attacks and pulmonary distress during betaxolol treatment.
• In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle. This may require constricting the pupil. Betaxolol has little or no effect on the pupil and should not be used alone in the treatment of angle-closure glaucoma.
• Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products. Instruct patients on appropriate instillation techniques.
• Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.
• The preservative in Betaxolol Ophthalmic, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of BETOPTIC S but may be reinserted 15 minutes after instillation.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• The symptoms which might be expected with an overdose of a systemically administered beta-adrenergic receptor inhibitor are bradycardia, hypotension, bronchospasm, and acute cardiac failure.

Management of overdosage:

• A topical overdose of Betaxolol Ophthalmic may be flushed from the eye(s) with warm tap water.
• If overdose occurs, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Betaxolol Ophthalmic administration in pregnant women to inform a drug-associated risk.
• There are limited data with the use of betaxolol eye drops in pregnant women.

Can this medicine be used in children?

• Safety and IOP lowering effect of Betaxolol Ophthalmic has been demonstrated in pediatric patients in a 3 month.

What are the active and inactive ingredients in this medicine?

Active:

• Betaxolol Hydrochloride

Inactives:

• Mannitol
• Edetate Disodium
• Hydrochloric Acid
• Sodium Hydroxide
• Benzalkonium Chloride
• Water

Who manufactures and distributes this medicine?

Distributed by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store upright at 2°C to 25°C (36°F to 77°F).
• Shake well before using.
• After opening, BETOPTIC S can be used until the expiration date on the bottle.

• Dailymed label info on Betaxolol Ophthalmic
• FDA Betaxolol Ophthalmic