Levobunolol (HCl)

Levobunolol (HCl) is a non selective, ß adrenergic blocking agent. Levobunolol (HCl) is synthesized chemically and optically active. The (S) enantiomer (levorotatory isomer) is used clinically, as Levobunolol (HCl) is 60 times more potent than the (R) enantiomeric in ß blocking activity. It reduces intra-ocular pressure (IOP) and used to treat glaucoma or other eye conditions. Levobunolol (HCl) is available for both ophthalmic and oral use.

Levobunolol (HCl) is primarily indicated in conditions like Ocular hypertension, Open-angle glaucoma, and can also be given in adjunctive therapy as an alternative drug of choice in Depression, Myocardial infarction.

Levobunolol (HCl) is contraindicated in conditions like Myasthenia gravis, Thyrotoxicosis, Cardiogenic shock, Sinus bradycardia, General anaesthesia, Second or third degree A-V block, Bronchial asthma.

In clinical trials the use of levobunolol hydrochloride 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 reactions have been reported rarely with the use of levobunolol hydrochloride ophthalmic solution: 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 levobunolol hydrochloride 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

As with other topically applied ophthalmic drugs, levobunolol hydrochloride ophthalmic solution 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 ). Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.

As with other topically applied ophthalmic drugs, levobunolol hydrochloride ophthalmic solution 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 ). Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.

0.25 mg (0.25 (0.25)) 12 hourly Ophthalmic — - 0.25 to 0.5 % (0.38 (0.375)) 12 hourly Ophthalmic — drops. Scraped Dose — 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 levobunolol hydrochloride ophthalmic solution 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.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Although levobunolol hydrochloride ophthalmic solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with levobunolol hydrochloride ophthalmic solution 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.

Eye Drops Store Below 40°C. Protect from Sunlight.