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The most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol® and timolol maleate (approximately one in eight patients).

The following adverse events were associated with use of Betimol® (timolol ophthalmic solution) in frequencies of more than 5% in two controlled, double-masked clinical studies in which 184 patients received 0.25% or 0.5% Betimol® (timolol ophthalmic solution) :

Ocular

Dry eyes, itching, foreign body sensation, discomfort in the eye, eyelid erythema, conjunctival injection, and headache.

Body as a whole

Headache.

The following side effects were reported in frequencies of 1 to 5%:

Ocular

Eye pain, epiphora, photophobia, blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis and cataract.

Body as a whole

Allergic reaction, asthenia, common cold and pain in extremities.

Cardiovascular

Hypertension.

Digestive

Nausea.

Metabolic/nutritional

Peripheral edema.

Nervous System/Psychiatry

Dizziness and dry mouth.

Respiratory

Respiratory infection and sinusitis.

In addition, the following adverse reactions have been reported with ophthalmic use of beta blockers:

Ocular

Conjunctivitis, blepharoptosis, decreased corneal sensitivity, visual disturbances including refractive changes, diplopia and retinal vascular disorder.

Body as a whole

Chest pain.

Cardiovascular

Arrhythmia, palpitation, bradycardia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure and cardiac arrest.

Digestive

Diarrhea.

Endocrine

Masked symptoms of hypoglycemia in insulin dependent diabetics (See WARNINGS).

Nervous system/psychiatry

Depression, impotence, increase in signs and symptoms of myasthenia gravis and paresthesia.

Respiratory

Dyspnea, bronchospasm, respiratory failure and nasal congestion.

Skin

Alopecia, hypersensitivity including localized and generalized rash, urticaria.

Beta-adrenergic blocking agents

Patients who are receiving a beta-adrenergic blocking agent orally and Betimol® (timolol ophthalmic solution) should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta-blockade.

Patients should not usually receive two topical ophthalmic beta-adrenergic blocking agents concurrently.

Catecholamine-depleting drugs

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving cate-cholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

Calcium antagonists

Caution should be used in the co-administration of beta-adrenergic blocking agents and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided.

Digitalis and calcium antagonists

The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

Injectable Epinephrine

(See PRECAUTIONS, General, Anaphylaxis.)

Last reviewed on RxList: 3/26/2009
This monograph has been modified to include the generic and brand name in many instances.