BETAGAN SIDE EFFECTS

SIDE EFFECTS

In clinical trials the use of BETAGAN^® ophthalmic solution has been associated with transient ocular burning and stinging in up to 1 in 3 patients, and with blepharoconjunctivitis in up to 1 in 20 patients. Decreases in heart rate and blood pressure have been reported.

The following adverse reactions have been reported rarely with the use of BETAGAN^® : iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus.

Decreased corneal sensitivity has been noted in a small number of patients. Although levobunolol has minimal membrane-stabilizing activity, there remains a possibility of decreased corneal sensitivity after prolonged use.

The following additional adverse reactions have been reported either with BETAGAN^® ophthalmic solution or ophthalmic use of other beta-adrenergic receptor blocking agents:

Body as a whole: Headache, asthenia, chest pain.

Cardiovascular: Bradycardia, arrhythmia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation, cardiac arrest.

Digestive: Nausea, diarrhea.

Psychiatric: Depression, confusion, increase in signs and symptoms of myasthenia gravis, paresthesia.

Skin: Hypersensitivity, including localized and generalized rash, alopecia, Stevens-Johnson Syndrome.

Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion.

Urogenital: Impotence.

Endocrine: Masked symptoms of hypoglycemia in insulin-dependent diabetics.

Special Senses: Signs and symptoms of keratitis or eye allergy, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis, and foreign body sensation in eye.

Other reactions associated with the oral use of non-selective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.

SRC: NLM .