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Uses

Ocular Hypertension and Glaucoma

Reduction of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma and ocular hypertension. Used alone or in conjunction wth a topical miotic (e.g., pilocarpine), topical dipivefrin, topical epinephrine, and/or a carbonic anhydrase inhibitor.

May be used safely in selected patients with reactive airway disease (e.g., asthma, chronic bronchitis, COPD). (See Respiratory Effects under Cautions.)

Dosage and Administration

General

• Adjust dosage to individual requirements and response of patient as determined by tonometric readings before and during therapy.
• Because of diurnal variations in IOP, measure IOP at different times during the day to determine if an adequate hypotensive effect is maintained. Since IOP may not stabilize for a few weeks after initiating therapy, determine IOP after about 4 weeks of therapy; thereafter, determine IOP as necessary.

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution or suspension.

Avoid contamination of the solution or suspension container.

Shake suspension well prior to use.

Suspension should not be administered while wearing contact lenses.

Dosage

Available as betaxolol hydrochloride; dosage expressed in terms of betaxolol.

Suspension is therapeutically equivalent (in terms of magnitude and duration of hypotensive effect) to solution.

Each 2.8 or 5.6 mg of betaxolol hydrochloride is equivalent to about 2.5 or 5 mg of betaxolol, respectively.

Adults

Ocular Hypertension and Glaucoma

Ophthalmic

Betaxolol solution: 1–2 drops of a 0.5% solution in affected eye(s) twice daily.

Betaxolol suspension: 1–2 drops of a 0.25% suspension in affected eye(s) twice daily.

If further reduction of IOP is required, a topical miotic, topical dipivefrin, topical epinephrine, and/or a carbonic anhydrase inhibitor may be added.

Cautions

Contraindications

Known hypersensitivity to betaxolol or any ingredient in the formulation.

Sinus bradycardia, AV block greater than first degree, cardiogenic shock, or overt cardiac failure that is not adequately compensated (e.g., with cardiac glycosides and/or diuretics).

Warnings/Precautions

Warnings

Systemic Effects

May be absorbed systemically following topical application to the eye; consider the usual precautions associated with systemic use of β-adrenergic blocking agents when using topical betaxolol.

Cardiovascular Effects

Severe cardiac reactions, including death associated with cardiac failure, have been reported in patients receiving topical (ocular) betaxolol.

Minor effects on BP and heart rate reported.

Use with caution in patients with a history of cardiac failure or heart block. Discontinue therapy at the first sign or symptom of cardiac failure.

Respiratory Effects

Severe respiratory reactions, including death resulting from bronchospasm, have been reported in patients with asthma receiving topical (ocular) betaxolol.

Increased airway resistance and pulmonary distress (i.e., dyspnea, bronchospasm, thickened bronchial secretions, asthma, respiratory failure) reported. Use caution in patients with evidence of reactive airway disease on pulmonary function testing or excessive restriction of pulmonary function.

Sensitivity Reactions

History of Atopy or Anaphylactic Reactions

Possible increased reactivity to repeated accidental, diagnostic, or therapeutic challenges with a variety of allergens while taking β-adrenergic blocking agents. Such patients may be unresponsive to usual doses of epinephrine used to treat anaphylactic reactions.

General Precautions

Diabetes Mellitus

β-Adrenergic blocking agents may mask sings and symptoms of acute hypoglycemia; administer with caution in patients subject to spontaneous hypoglycemia and in diabetic patients (especially those with labile diabetes) who are receiving hypoglycemic agents.

Thyrotoxicosis

β-Adrenergic blocking agents may mask signs of hyperthyroidism (e.g., tachycardia).

Possible thyroid storm if β-adrenergic blocking agent is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.

Muscle Weakness

β-Adrenergic blocking agents reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, generalized weakness).

Betaxolol reported rarely to increase muscle weakness in patients with myasthenia gravis or myasthenia symptoms.

Major Surgery

Possible increased risks associated with general anesthesia (e.g., severe hypotension, difficulty restarting or maintaining heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli. Some clinicians recommend gradual withdrawal of β-adrenergic blocking agents prior to elective surgery.

Angle-closure Glaucoma

Betaxolol has little to no effect on pupil size. Do not use alone in patients with angle-closure glaucoma; use only in combination with a miotic in these patients.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk. Caution advised if used in nursing women.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Ocular stinging and discomfort on instillation.