Ophthalmic betaxolol solution at 1% (one drop each eye) was compared to placebo in a crossover study challenging nine patients with reactive airway disease. The action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol. Betaxolol HCl had no significant effect on pulmonary function as measured by FEV 1, Forced Vital Capacity (FVC), FEV 1 /FVC and was not significantly different from placebo.
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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
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Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.
Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic receptor inhibitors, which might precipitate a thyroid storm. Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia ) of hyperthyroidism.
Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 10 minutes before instilling BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Suspension.
In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle. This may require constricting the pupil. Betaxolol has little or no effect on the pupil and should not be used alone in the treatment of angle-closure glaucoma.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.
Betaxolol HCl, a cardioselective (beta-1adrenergic) receptor inhibitor, does not have significant membrane-stabilizing (local anesthetic ) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic receptor inhibitors reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function.
physician's present multidose container. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections.
Lifetime studies with betaxolol HCl have been completed in mice at oral doses of 6, 20 or 60 mg/kg/day and in rats at 3, 12 or 48 mg/kg/day; betaxolol HCl demonstrated no carcinogenic effect. Higher dose levels were not tested. In a variety of in vitro and in vivo bacterial and mammalian cell assays, betaxolol HCl was nonmutagenic.
Preservative: benzalkonium chloride 0.01%. Suspension 0.25% contains: Active: betaxolol HCl 2.8 mg equivalent to 2.5 mg of betaxolol base. Inactive(s): Mannitol, Poly(Styrene-Divinyl Benzene ) sulfonic acid, Carbomer 934P, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has a pH of approximay 7.6 and an osmolality of approximay 290 mOsmol/kg.
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Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER package. BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% is supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER dispensers.
This may augment the risk of general anesthesia in surgical procedures. In patients undergoing elective surgery, consider gradual withdrawal of beta-adrenergic receptor inhibitors. Some patients receiving beta-adrenergic receptor inhibitors have experienced protracted, severe hypotension during anesthesia. Beta-adrenergic receptor inhibitors impair the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. If necessary during surgery, the effects of beta-adrenergic receptor inhibitors may be reversed by sufficient doses of adrenergic agonists. Difficulty in restarting and maintaining the heartbeat has also been reported. The necessity or desirability of withdrawal of beta-adrenergic receptor inhibitors prior to major surgery is controversial.
While taking beta receptor inhibitors, 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.
BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.
Systemic adverse reactions include: Cardiovascular: Bradycardia, heart block and congestive failure.
Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia. Beta-adrenergic receptor inhibitors should be administered with caution in patients subject to hypoglycemia or to diabetic patients (especially those with labile diabetes ) who are receiving insulin or oral hypoglycemic agents.
Betoptic S (betaxolol hydrochloride) Ophthalmic Suspension 0.25% as Base, Sterile Topical Ophthalmic Drops.
Shake well before using. Store upright at 2°- 25°C (36°- 77°F).
Each mL of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic.
Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products when.
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 re-challenges 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-adrenergic receptor inhibitors cannot be ruled out.
BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Suspension is contraindicated in patients with:
Because many drugs are excreted in human milk, caution should be exercised when BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% is administered to nursing women. It is not known whether betaxolol HCl is excreted in human milk.
There are no adequate and well-controlled studies in pregnant women. Pregnancy Category C: Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betaxolol HCl was not shown to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels.
Ocular: blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes.
BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% is indicated for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients:.
Betaxolol has the action of reducing elevated as well as normal intraocular pressure and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Elevated IOP presents a major risk factor in glaucomatous field loss.
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2.5 mL: NDC.
Patients who are receiving a beta-adrenergic receptor inhibitor orally and BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade.
The onset of action with betaxolol can generally be noted within 30 minutes and the maximum effect can usually be detected 2 hours after topical administration. As with any new medication, careful monitoring of patients is advised. A single dose provides a 12-hour reduction in intraocular pressure. In some patients, the intraocular pressure lowering responses to BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) may require a few weeks to stabilize.
10 mL: NDC.
Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) should be discontinued at the first signs of cardiac failure. BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Suspension has been shown to have a minor effect on heart rate and blood pressure in clinical studies.
Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters. When instilled in the eye, BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has the action of reducing elevated intraocular pressure, whether or not accompanied by glaucoma.
The chemical structure is presented below. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89. BETOPTIC S Ophthalmic Suspension 0.25% contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Empirical Formula:.
these containers are inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Instruct patients on appropriate instillation techniques.
No evidence of cardiovascular beta adrenergic-blockade during exercise was observed with betaxolol in a double-masked, crossover study in 24 normal subjects comparing ophthalmic betaxolol and placebo for effects on blood pressure and heart rate.
For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported with topical application of beta-adrenergic receptor inhibitors. As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta- adrenergic receptor inhibitors may occur with topical administration.
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Other: Hives, toxic epidermal necrolysis, hair loss, and glossitis. Perversions of taste and smell have been reported.
Safety and IOP-lowering effect of.
Fort Worth, Texas 76134. FDA Rev date: 5/8/2008. Alcon Laboratories, Inc.
Betaxolol is an adrenergic receptor inhibitor; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.
Close observation of the patient is recommended when a beta-adrenergic receptor inhibitor is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia which may result in vertigo, syncope, or postural hypotension.
Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formations, edema and anisocoria.
Because of potential effects of beta-adrenergic receptor inhibitors on blood pressure and pulse, these inhibitors should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with BETOPTIC S (betaxolol hydrochloride ophthalmic suspension), alternative therapy should be considered.
C 18 H 29 NO 3 •HCl Chemical Name: ()-1-[p-phenoxy]3-(isopropylamino)-2-propanol hydrochloride.
15 mL: NDC.
The oral LD 50 of the drug ranged from 350-920 mg/kg in mice and mg/kg in rats. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic receptor inhibitor are bradycardia, hypotension and acute cardiac failure. No information is available on overdosage of humans.
Instill one drop of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% in the affected eye twice daily. It may be used alone or in combination with other intraocular pressure lowering medications.
A topical overdose of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% may be flushed from the eye(s) with warm tap water.
Beta-adrenergic receptor inhibitors have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).
Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure.
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Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis.
How to Use The DROP-TAINER*Bottle.
In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% and BETOPTIC Ophthalmic Solution 0.5% were clinically equivalent. BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Suspension was significantly more comfortable than BETOPTIC Solution.
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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5 mL: NDC.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
Bottle filled with 2.5, 5, 10, and 15 mL of 0.25% sterile ophthalmic suspension.
The DROP-TAINER bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER bottle, read the complete instructions carefully.Betoptic