Drug: Betagan

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. STRUCTURAL FORMULA: Levobunolol HCl 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.

Source: http://www.rxlist.com

In clinical trials, the use of BETAGAN® (levobunolol) 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® (levobunolol) : 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® (levobunolol) 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. Read the Betagan (levobunolol) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

The recommended starting dose is one to two drops of BETAGAN® (levobunolol) ophthalmic solution 0.5% in the affected eye(s) once a day. Typical dosing with BETAGAN® (levobunolol) 0.25% is one to two drops twice daily. In patients with more severe or uncontrolled glaucoma, BETAGAN® (levobunolol) 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® (levobunolol) 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.

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Although BETAGAN® (levobunolol) ophthalmic solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with BETAGAN® (levobunolol) 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, patients with a history of severe anaphylactic reactions 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. Animal Studies: No adverse ocular effects were observed in rabbits administered BETAGAN® (levobunolol) ophthalmic solution topically in studies lasting one year in concentrations up to 10 times the human dose concentration. Read the Betagan Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

BETAGAN® (levobunolol) 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.

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BETAGAN® (levobunolol) 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. Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No data are available regarding overdosage in humans. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. If accidentally ingested, efforts to decrease further absorption may be appropriate (gastric lavage). The most common signs and symptoms to be expected with overdosage with administration of a systemic beta-adrenergic blocking agent are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure. Should these symptoms occur, discontinue BETAGAN® (levobunolol) therapy and initiate appropriate supportive therapy. The following supportive measures should be considered:
  1. Symptomatic bradycardia: Use atropine sulfate intravenously in a dosage of 0.25 mg to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride should be administered cautiously. In refractory cases, the use of a transvenous cardiac pacemaker should be considered.
  2. Hypotension: Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases, the use of glucagon hydrochloride may be useful.
  3. Bronchospasm: Use isoproterenol hydrochloride. Additional therapy with aminophylline may be considered.
  4. Acute cardiac failure: Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases, the use of intravenous aminophylline is suggested. This may be followed, if necessary, by glucagon hydrochloride, which may be useful.
  5. Heart block (second or third degree): Use isoproterenol hydrochloride or a transvenous cardiac pacemaker.

Source: http://www.rxlist.com

BETAGAN® (levobunolol hydrochloride ophthalmic solution USP) Liquifilm® sterile ophthalmic solution is supplied in white opaque plastic dropper bottles as follows: BETAGAN 0.25%: C Cap® Compliance Cap B.I.D. (twice daily)   5 mL--NDC 11980-469-25 10 mL--NDC 11980-469-20 BETAGAN 0.5%: Standard Cap C Cap® Compliance Cap C CAP® Compliance Cap 2 mL--NDC 11980-252-02 Q.D.(once daily) B.I.D. (twice daily)   5 mL--NDC 11980-252-65 5 mL--NDC 11980-252-25   10 mL--NDC 11980-252-60 10 mL--NDC 11980-252-20   15 mL--NDC 11980-252-61 15 mL--NDC 11980-252-21 NOTE: Protect from light. Store at 15°-30°C (59°-86°F). Allergan Inc, Irvine, Califomia 29612, U.S.A. FDA rev date: 4/12/2002 Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General BETAGAN® (levobunolol) ophthalmic solution 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® (levobunolol) 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® (levobunolol) , 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® (levobunolol) ophthalmic solution has little or no effect on the pupil. When BETAGAN® (levobunolol) is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be followed with a miotic and not alone. Muscle Weakness Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness). Carcinogenesis, mutagenesis, impairment of fertility In a lifetime oral study in mice, there were statistically significant (p < /= 0.05) increases in the incidence of benign leiomyomas in female mice at 200 mg/kg/day (14,000 times the recommended human dose for glaucoma), but not at 12 or 50 mg/kg/day (850 and 3,500 times the human dose). In a two-year oral study of levobunolol HCl in rats, there was a statistically significant (p < /= 0.05) increase in the incidence of benign hepatomas in male rats administered 12,800 times the recommended human dose for glaucoma. Similar differences were not observed in rats administered oral doses equivalent to 350 times to 2,000 times the recommended human dose for glaucoma. Levobunolol did not show evidence of mutagenic activity in a battery of microbiological and mammalian in vitro and in vivo assays. Reproduction and fertility studies in rats showed no adverse effect on male or female fertility at doses up to 1,800 times the recommended human dose for glaucoma. Pregnancy Category C Fetotoxicity (as evidenced by a greater number of resorption sites) has been observed in rabbits when doses of levobunolol HCl equivalent to 200 and 700 times the recommended dose for the treatment of glaucoma were given. No fetotoxic effects have been observed in similar studies with rats at up to 1,800 times the human dose for glaucoma. Teratogenic studies with levobunolol in rats at doses up to 25 mg/kg/day (1,800 times the recommended human dose for glaucoma) showed no evidence of fetal malformations. There were no adverse effects on postnatal development of offspring. It appears when results from studies using rats and studies with other beta-adrenergic blockers are examined, that the rabbit may be a particularly sensitive species. There are no adequate and well controlled studies in pregnant women. BETAGAN® (levobunolol) ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Systemic beta-blockers and topical timolol maleate are known to be excreted in human milk. Caution should be exercised when BETAGAN® (levobunolol) is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric use No overall differences in safety or effectiveness have been observed between elderly and younger patients.Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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