Product Description.:
Drops , clear , clear
Colorless to light yellowish
BETAGAN? (levobunolol hydrochloride ophthalmic solution USP) sterile is a noncardioselective beta-adrenoceptor blocking agent for ophthalmic use.
CHEMICAL NAME: LevobunololHCl: (-)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-1(2H)-naphthalenone hydrochloride.
Contains:
Active: levobunolol HCl 0.25% or 0.5%.
Preservative: benzalkonium chloride (0.004%).
Inactives: polyvinyl alcohol1.4% edetate disodium sodium metabisulfite sodium phosphate, dibasic potassium phosphate, monobasic sodium chloride hydrochloric acid or sodium hydroxide to adjust the pH and purified water.
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
The recommended starting dose is one to two drops of BETAGAN? ophthalmic solution 0.5% in the affected eye(s) once a day. Typical dosing with BETAGAN? 0.25% is one to two drops twice daily. In patients with more severe or uncontrolled glaucoma, BETAGAN? 0.5% can be administered b.i.d. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of BETAGAN? 0.5% b.i.d. are not generally more effective. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with dipivefrin and/or epinephrine, and/or pilocarpine and other miotics, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
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 (see CONTRAINDICATIONS and WARNINGS).
The following adverse effects 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 (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? ophthalmic solution 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 hypotensive effects due to the inhibition of each other's metabolism.
Risk of anaphylactic reaction: While taking beta-blockers, p
