Betoptic

Betaxolol is a beta-blocker that reduces pressure inside the eye.

Betaxolol ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Betaxolol ophthalmic may also be used for other purposes not listed in this medication guide.

Do not use this medication if you are allergic to betaxolol, or if you have asthma, or severe chronic obstructive pulmonary disease (COPD), slow heartbeats, or a heart condition called "AV block."

Before using this medication, tell your doctor if you have breathing problems such as bronchitis or emphysema, a history of heart disease or congestive heart failure, diabetes, history of stroke, blood clot, or circulation problems, a thyroid disorder, or a muscle disorder such as myasthenia gravis.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Betaxolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using betaxolol ophthalmic. Do not use the medications at the same time.

Betaxolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use this medication while you are wearing contact lenses. Betaxolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using betaxolol before putting your contact lenses in.

Do not use this medication if you are allergic to betaxolol, or if you have:

• asthma, or severe chronic obstructive pulmonary disease (COPD);
• slow heartbeats; or
• a heart condition called "AV block."

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• breathing problems such as bronchitis or emphysema;
• a history of heart disease or congestive heart failure;
• diabetes;
• history of stroke, blood clot, or circulation problems;
• a thyroid disorder; or
• a muscle disorder such as myasthenia gravis.

FDA pregnancy category C. It is not known whether betaxolol ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether betaxolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
• drainage, crusting, or oozing of your eyes or eyelids;
• bronchospasm (wheezing, chest tightness, trouble breathing);
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• feeling short of breath, even with mild exertion; or
• swelling, rapid weight gain.

Less serious side effects may include:

• mild burning, stinging, itching, or discomfort of your eyes;
• dry eyes, blurred vision;
• mildly swollen or puffy eyes;
• feeling like something is in your eye;
• headache, dizziness, spinning sensation;
• depression;
• sleep problems (insomnia);
• muscle weakness; or
• altered sense of taste or smell.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Betaxolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Betaxolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using betaxolol ophthalmic. Do not use the medications at the same time.

Before using betaxolol ophthalmic, tell your doctor if you are using any of the following drugs:

• oral betaxolol (Blocadren);
• digoxin (digitalis, Lanoxin);
• reserpine;
• insulin or diabetes medications you take by mouth;
• any other beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;
• a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan); or
• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), or thioridazine (Mellaril).

This list is not complete and there may be other drugs that can interact with betaxolol ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

>10%

Ocular effects

• Short term discomfort (<25%)

Frequency Not Defined

Ocular

• Blurred vision
• Corneal punctate keratitis
• Itching and/or foreign body sensation erythema
• Inflammation
• Ocular pain and/or discharge
• Ocular drynes
• Photophobia

Systemic

• Bradycardia, congestive heart failure, heart block
• Depression, dizziness, headache, insomnia, lethargy, vertigo
• Hair loss, hives, toxic epidermal necrolysis
• Glossitis
• Bronchospasm, dyspnea
• Increase in signs and symptoms of myasthenia gravis

Pregnancy Category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

General

Information for Patients. Do not touch dropper tip to any surface as this may contaminate the solution.

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., diplopla, 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.

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.

Drug Interactions

Patients who are receiving a beta-adrenergic blocking agent orally and Betoptic Ophthalmic Solution 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 patients 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.

Betaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

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. Betaxolol has little or no effect on the pupil. When the Betoptic Ophthalmic Solution 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

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.

Pregnancy

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. Betaxolol HCl was not shown to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels. There are no adequate and well-controlled studies in pregnant women. Betoptic 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 betaxolol HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BEOPTIC Ophthalmic Solution is administered to nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

No information is available on overdosage of humans. The oral LD50 of the drug ranged from 350-920 mg/kg in mice and 860-1050 mg/kg in rats. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic receptor blocker agent are bradycardia, hypotension and acute cardiac failure. A topical overdose of Betoptic Ophthalmic Solution may be flushed from the eye(s) with warm tap water.

The recommended dose is one to two drops of Betoptic Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betoptic Ophthalmic Solution may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.

If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.

Betoptic Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER® dispensers.

2.5 mL: NDC 0065-0245-20   10 mL: NDC 0065-0245-10

5 mL: NDC 0065-0245-05   15 mL: NDC 0065-0245-15

STORAGE

Store at room temperature

Rx Only

U.S. Patents Nos. 4,252,984; 4,311,708; 4,342,783

ALCON®

OPHTHALMIC

ALCON LABORATORIES, INC

Fort Worth, Texas 76134 USA

Printed in USA

236015-0598

Applies to betaxolol ophthalmic: ophthalmic solution, ophthalmic suspension

General

The most commonly reported side effect was eye discomfort.[Ref]

Ocular

Very common (10% or more): Eye discomfort (16%)
Common (1% to 10%): Foreign body sensation in eyes
Uncommon (0.1% to 1%): Tearing on instillation of the drops, punctate keratitis, asthenopia, eye discharge, eyelid margin crusting, conjunctival disorder, conjunctival edema, ocular hyperemia
Rare (less than 0.1%): Signs and symptoms of ocular irritation (e.g., burning, stinging, itching, tearing, redness), pain, corneal punctuate staining, decreased corneal sensitivity, dry eyes, blepharitis, keratitis, blurred vision, anisocoria, photophobia, blepharoconjunctivitis, cataract, refraction disorder
Frequency not reported: Choroidal detachment following filtration surgery, corneal erosion, ptosis, diplopia[Ref]

Hypersensitivity

Rare (less than 0.1%): Systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction[Ref]

Cardiovascular

Rare (less than 0.1%): Bradycardia, atrioventricular block, cardiac failure, hypotension, Raynaud's phenomenon, cold hands and feet, exacerbation of intermittent claudication
Frequency not reported: Congestive heart failure, chest pain, palpitations, edema, arrhythmia, cardiac arrest[Ref]

Respiratory

Uncommon (0.1% to 1%): Rhinitis
Rare (less than 0.1%): Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnea, asthma, rhinorrhea
Frequency not reported: Cough, thickened bronchial secretions, respiratory failure, antral lavage[Ref]

Psychiatric

Rare (less than 0.1%): Insomnia, sleep disorders, depression, hallucinations, psychoses, confusion, nightmares[Ref]

Nervous system

Rare (less than 0.1%): Dizziness, paresthesia, headache
Frequency not reported: Memory loss, syncope, cerebrovascular accident, cerebral ischemia, increases in signs and symptoms of myasthenia gravis, dysgeusia, vertigo, lethargy[Ref]

Gastrointestinal

Rare (less than 0.1%): Nausea, vomiting, diarrhea
Frequency not reported: Dyspepsia, dry mouth, abdominal pain, glossitis[Ref]

Dermatologic

Rare (less than 0.1%): Alopecia, skin rash
Frequency not reported: Psoriasiform rash or exacerbation of psoriasis, hives, toxic epidermal necrolysis, hair loss, periorbital edema[Ref]

Endocrine

Rare (less than 0.1%): Masking of the symptoms of thyrotoxicosis[Ref]

Genitourinary

Rare (less than 0.1%): Sexual dysfunction
Frequency not reported: Decreased libido[Ref]

Immunologic

Rare (less than 0.1%): Increase in anti-nuclear antibodies (ANA)[Ref]

Metabolic

Rare (less than 0.1%): Hypoglycemia[Ref]

Musculoskeletal

Frequency not reported: Myalgia[Ref]

Other

Frequency not reported: Asthenia[Ref]

Some side effects of Betoptic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.