Product Description.:
Drops , clear
Colorless to light yellow
BETAGAN? (levobunolol hydrochloride ophthalmic solution, USP) sterile is a noncardioselective beta-adrenoceptor blocking agent for ophthalmic use. The solution is colorless to slightly light yellow in appearance with an osmolality range of 250-360 mOsm/kg. The shelf life pH range is 5.5 to 7.5.
Contains: Active: levobunolol HCl 0.25% or 0.5%. Preservative: benzalkonium chloride 0.004% Inactives: edetate disodium polyvinyl alcohol 1.4% potassium phosphate, monobasic purified water sodium chloride sodium metabisulfite sodium phosphate, dibasic and hydrochloric acid or sodium hydroxide to adjust pH.
INDICATIONS AND USAGE
BETAGAN? ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
CONTRAINDICATIONS
BETAGAN? ophthalmic solution is contraindicated in those individuals with bronchial asthma, or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS) sinus bradycardia second and third degree atrioventricular block overt cardiac failure (see WARNINGS) cardiogenic shock or hypersensitivity to any component of these products.
WARNINGS
As with other topically applied ophthalmic drugs, BETAGAN? may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents [See CONTRAINDICATIONS].
PRECAUTIONS
General:
BETAGAN? (levobunolol hydrochloride ophthalmic solution, USP) sterile should be used with caution in patients with known hypersensitivity to other beta-adrenoceptor blocking agents.
Use with caution in patients with known diminished pulmonary function.
BETAGAN? should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade or on intraocular pressure. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
Because of the potential effects of beta-adrenergic blocking agents on blood pressure and pulse rates, these medications must be used cautiously in patients with cerebrovascular insufficiency. Should signs or symptoms develop that suggest reduced cerebral blood flow while using BETAGAN? ophthalmic solution, alternative therapy should be considered.
In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires, in most cases, constricting the pupil with a miotic. BETAGAN? ophthalmic solution has little or no effect on the pupil. When BETAGAN? is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be followed with a miotic and not alone.
