Topically applied beta-adrenergic blocking agents 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.

BETAXON™ Ophthalmic Suspension has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with BETAXON™ Ophthalmic Suspension should be discontinued at the first signs of cardiac failure.

General:

Diabetes Mellitus.   Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis.   Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents, which might precipitate a thyroid storm.

Muscle Weakness.   Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

Major Surgery.   Consideration should be given to the gradual withdrawal of beta-adrenergic blocking agents prior to general anesthesia because of the reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli.

Pulmonary.   Caution should be exercised in the treatment of glaucoma patients with excessive restriction of pulmonary function. There have been reports of asthmatic attacks and pulmonary distress during betaxolol treatment. Although rechallenges of some such patients with ophthalmic betaxolol has not adversely affected pulmonary function test results, the possibility of adverse pulmonary effects in patients sensitive to beta blockers cannot be ruled out.

Information for Patients:   Do not touch dropper tip to any surface, as this may contaminate the contents. Do not use with contact lenses in eyes.

Drug Interactions:   Patients who are receiving a beta-adrenergic blocking agent orally and BETAXON™ Ophthalmic Suspension should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade. 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 bradycardia. Levobetaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

Risk from anaphylactic reaction:   While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Ocular:   In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle by constriction of the pupil with a miotic agent. Racemic betaxolol has little or no effect on the pupil. It is expected that levobetaxolol will also have little or no effect on the pupil. When BETAXON™ Ophthalmic Suspension is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.

Carcinogenesis, Mutagenesis, Impairment of Fertility:   In lifetime studies in mice at oral doses of 6, 20 and 60 mg/kg/day and in rats at oral doses of 3, 12 and 48 mg/kg/day, betaxolol HCl demonstrated no carcinogenic effect. Higher dose levels were not tested. Levobetaxolol was not mutagenic in the Ames assay, chromosomal aberration, mouse lymphoma, and cell transformation assays in vitro. Levobetaxolol demonstrated potential mutagenicity in the sister chromatid exchange assay in Chinese Hamster Ovarian cell in vitro in the presence of metabolic activation systems.

Pregnancy: Pregnancy Category C.   Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl and levobetaxlol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits with levobetaxolol HCl at 12 mg/kg/day and sternebrae malformations at 4 mg/kg/day. No other adverse effects on reproduction were noted at subtoxic dose levels. There are no adequate and well-controlled studies in pregnant women.

BETAXON™ Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:   It is not known whether BETAXON™ Ophthalmic Suspension is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BETAXON™ Ophthalmic Suspension is administered to nursing women.

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 other adult patients.

Bookmark this page: