Betoptic S Side Effects

Generic name: betaxolol ophthalmic

Note: This document contains side effect information about betaxolol ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Betoptic S.

Some side effects of Betoptic S may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to betaxolol ophthalmic: ophthalmic solution, ophthalmic suspension

Get emergency medical help if you have any of these signs of an allergic reaction while taking betaxolol ophthalmic (the active ingredient contained in Betoptic S) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;

• drainage, crusting, or oozing of your eyes or eyelids;

• bronchospasm (wheezing, chest tightness, trouble breathing);

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• feeling short of breath, even with mild exertion; or

• swelling, rapid weight gain.

Less serious side effects of betaxolol ophthalmic may include:

• mild burning, stinging, itching, or discomfort of your eyes;

• dry eyes, blurred vision;

• mildly swollen or puffy eyes;

• feeling like something is in your eye;

• headache, dizziness, spinning sensation;

• depression;

• sleep problems (insomnia);

• muscle weakness; or

• altered sense of taste or smell.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to betaxolol ophthalmic: ophthalmic solution, ophthalmic suspension

General

Although systemic adverse events are infrequently reported, topically applied betaxolol ophthalmic (the active ingredient contained in Betoptic S) drops may be absorbed systemically and side effects similar to systemically administered betaxolol or other beta-blockers such as severe respiratory or cardiac reactions may be experienced.

Ocular

Ocular side effects have frequently included transient ocular discomfort and ocular irritation in up to 25% of patients. Blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity, crusty lashes, noninfectious dendritic epithelial keratitis, anisocoria, photophobia, and anterior uveitis have been reported rarely. A smaller number of patients with glaucoma may have corneal sensitivity to betaxolol. In addition, choroidal detachment has been reported after filtration procedures and cases of bacterial keratitis have been reported as a result of inadvertent contamination by patients.

Betaxolol has caused histamine release from human leukocytes, which may account for its irritant effects.

Cardiovascular

An 81-year-old man with a history of hypertension and glaucoma suffered an acute myocardial infarction within five minutes after a single drop of betaxolol 0.5% ophthalmic solution. The author believes that betaxolol may have allowed alpha-mediated coronary artery vasospasm, although severe hypotension or an arrhythmia could not be ruled out. Carotid sinus syncope was considered as a result of hyperextension of the patient's neck while using the eyedrops, but was thought to be unlikely since the syncope occurred minutes later.

Cardiovascular side effects have included bradycardia, heart block and congestive failure. It should be noted that death due to cardiac failure has been reported following use of topical beta-blockers.

One case of myocardial infarction has been associated with betaxolol.

Respiratory

Respiratory side effects have included dyspnea, bronchospasm, thickened bronchial secretions, asthma. and respiratory failure.

Respiratory side effects are related to the ability of betaxolol to inhibit bronchodilation, which may be important in some patients with reversible airway disease, including asthma or severe obstructive lung disease.

A 74-year-old woman with a subarachnoid hemorrhage developed acute pulmonary edema and wheezing after betaxolol eyedrops and intravenous labetalol were administered for open angle glaucoma and hypertension. Congestive heart failure and hypervolemia were ruled out by hemodynamic measurements. The authors of this case report diagnosed acute bronchospasm based on the clinical picture and low cardiac filling pressures. The patient had never smoked, had no personal or family history of asthma, ruled out for myocardial infarction, developed no new ECG findings, and had no recurrent wheezing or hypoxemia when captopril was substituted for labetalol and betaxolol was discontinued.

Nervous system

Nervous system side effects have included nightmares, insomnia, dizziness, vertigo, headache, depression, lethargy, and increases in the signs and symptoms of myasthenia gravis.

A 75-year-old man experienced chronic and frightening nightmares associated with betaxolol eyedrops, which were alleviated after he shut his eyes tightly after administration. By doing so, the lacrimal ducts were occluded, which is thought to significantly decrease the systemic absorption of the eyedrops.

Gastrointestinal

Gastrointestinal side effects have rarely included general gastrointestinal disturbances, such as diarrhea or nausea.

Hypersensitivity

Hypersensitivity side effects have included dermatitis, hives, and toxic epidermal necrolysis.

Dermatologic

Dermatologic side effects have included hair loss and glossitis.

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