SIDE EFFECTS
In clinical trials the use of BETAGAN 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 (see CONTRAINDICATIONS and WARNINGS).
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
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 (see WARNINGS).
Special Senses: Signs and symptoms of
keratitis, blepharoptosis, visual disturbances including
refractive changes (due to withdrawal of miotic therapy
in some cases), diplopia, ptosis.
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.
DRUG INTERACTIONS
Although BETAGAN used alone has little or no effect on
pupil size, mydriasis resulting from concomitant therapy
with BETAGAN and epinephrine may occur.
Close observation of the patient is recommended when
a beta-blocker is administered to patients receiving catecholamine-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.
Patients receiving beta-adrenergic blocking agents along
with either oral or intravenous calcium antagonists should
be monitored for possible atrioventricular conduction
disturbances, left ventricular failure and hypotension.
In patients with impaired cardiac function, simultaneous
use should be avoided altogether.
The concomitant use of beta-adrenergic blocking agents
with digitalis and calcium antagonists may have additive
effects on prolonging atrioventricular conduction time.
Phenothiazine-related compounds and beta-adrenergic blocking
agents may have additive hypotensite effects due to the
inhibition of each other’s metabolism.
Risk of anaphylactic reaction: While
taking beta-blockers, patients with a history of severe
anaphylactic reaction to a variety of allergens may be
more reactive to repeated challenge, either accidental,
diagnostic, or therapeutic. Such patients may be unresponsive
to the usual doses of epinephrine used to treat allergic
reaction.
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