NDC 0065-0246 Betoptic S

Betaxolol Hydrochloride

NDC Product Code 0065-0246

NDC 0065-0246-10

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 10 mL in 1 BOTTLE, PLASTIC

NDC 0065-0246-15

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 15 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Betoptic S with NDC 0065-0246 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Betoptic S is betaxolol hydrochloride. The product's dosage form is suspension/ drops and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Betoptic S Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BETAXOLOL HYDROCHLORIDE 2.8 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MANNITOL (UNII: 3OWL53L36A)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA019845 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-15-1996 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Betaxolol Ophthalmic

Betaxolol Ophthalmic is pronounced as (be tax' oh lol)

Why is betaxolol ophthalmic medication prescribed?
Ophthalmic betaxolol is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Betaxolol is in a class of medicati...
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Betoptic S Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

BETOPTIC S® Ophthalmic Suspension 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.

2 Dosage And Administration

Instill one drop of BETOPTIC S Ophthalmic Suspension 0.25% in the affected eye(s) twice daily. BETOPTIC S may be used alone or in combination with other IOP lowering medications.

3 Dosage Forms And Strengths

Bottle filled with 10 and 15 mL of 0.25% sterile ophthalmic suspension

4 Contraindications

  • BETOPTIC S Ophthalmic Suspension 0.25% is contraindicated in patients with:sinus bradycardiagreater than a first degree atrioventricular blockcardiogenic shockpatients with overt cardiac failurehypersensitivity to any component of this product.

5.1 General

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. 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.

5.2 Cardiac Failure

BETOPTIC S Ophthalmic Suspension 0.25% 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 BETOPTIC S Ophthalmic Suspension 0.25% should be discontinued at the first signs of cardiac failure.

5.3 Diabetes Mellitus

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. Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia.

5.4 Thyrotoxicosis

Beta-adrenergic receptor inhibitors 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 receptor inhibitors, which might precipitate a thyroid storm.

5.5 Muscle Weakness

Beta-adrenergic receptor inhibitors have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

5.6 Surgical Anesthesia

The necessity or desirability of withdrawal of beta-adrenergic receptor inhibitors prior to major surgery is controversial. Beta-adrenergic receptor inhibitors impair the ability of the heart to respond to beta adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor inhibitors have experienced protracted, severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. In patients undergoing elective surgery, consider gradual withdrawal of beta-adrenergic receptor inhibitors. If necessary during surgery, the effects of beta-adrenergic receptor inhibitors may be reversed by sufficient doses of adrenergic agonists.

5.7 Bronchospasm And Obstructive Pulmonary Disease

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.

5.8 Atopy/Anaphylaxis

While taking beta-adrenergic 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.

5.9 Angle-Closure Glaucoma

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.

5.10 Vascular Insufficiency

Because of potential effects of beta-adrenergic receptor inhibitors on blood pressure and pulse, these inhibitors should be used with caution in patients with vascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow or Raynaud’s phenomenon develop following initiation of therapy with BETOPTIC S Ophthalmic Suspension 0.25%, alternative therapy should be considered.

5.11 Bacterial Keratitis

Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products when 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 [see Patient Counseling Information (17)].

5.12 Choroidal Detachment

Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.

5.13 Contact Lens Wear

The preservative in BETOPTIC S Ophthalmic Suspension 0.25%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of BETOPTIC S Ophthalmic Suspension 0.25% but may be reinserted 15 minutes after instillation [see Patient Counseling Information (17)].

6.1 Clinical Trials Experience

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.In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients: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.Systemic adverse reactions include:Cardiovascular: Bradycardia, heart block and congestive failure.Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure.Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis.Other: Hives, toxic epidermal necrolysis, hair loss and glossitis. Perversions of taste and smell have been reported.In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.

6.2 Additional Potential Adverse Reactions Associated With Betaxolol

Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formation, edema and anisocoria.

7.1 Oral Beta-Adrenergic Receptor Inhibitors

Patients who are receiving a beta-adrenergic receptor inhibitor orally and BETOPTIC S Ophthalmic Suspension 0.25% should be observed for a potential additive effect either on the IOP or on the known systemic effects of beta blockade.

7.2 Catecholamine-Depleting 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.

7.3 Concomitant Adrenergic Psychotropic Drugs

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

7.4 Calcium Antagonists, Antiarrhythmics And Digitalis

The concomitant use of a beta-adrenergic receptor inhibitor with calcium antagonists, antiarrhythmics (including amiodarone) or digitalis may have additive effects resulting in hypotension and/or marked bradycardia.

8.1 Pregnancy

Teratogenic EffectsPregnancy 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 S Ophthalmic Suspension 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 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 BETOPTIC S Ophthalmic Suspension 0.25% is administered to nursing women.

8.4 Pediatric Use

Safety and IOP lowering effect of BETOPTIC S Ophthalmic Suspension 0.25% has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.

8.5 Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

10 Overdosage

No information is available on overdosage in 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-adrenergic receptor inhibitor are bradycardia, hypotension, bronchospasm and acute cardiac failure.A topical overdose of BETOPTIC S Ophthalmic Suspension 0.25% may be flushed from the eye(s) with warm tap water.  If overdose occurs, treatment should be symptomatic and supportive.

11 Description

BETOPTIC S Ophthalmic Suspension 0.25% contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89. The chemical structure is presented below.Empirical Formula: C18H29NO3•HClChemical Name:(±)-1-[p-[2-(cyclopropylmethoxy) ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.Each mL of BETOPTIC S Ophthalmic Suspension 0.25% contains: Active: betaxolol HCl 2.8 mg equivalent to 2.5 mg of betaxolol base. Preservative: benzalkonium chloride 0.01%. Inactives: mannitol, poly (styrene-divinyl benzene) sulfonic acid, carbomer 934P, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.BETOPTIC S Ophthalmic Suspension 0.25% has pH of approximately 7.6 and an osmolality of approximately 290 mOsmol/kg.

12.1 Mechanism Of Action

Betaxolol HCl, a cardioselective (beta-1-adrenergic) 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.When instilled in the eye, BETOPTIC S Ophthalmic Suspension 0.25% has the action of reducing elevated IOP, whether or not accompanied by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Betaxolol has the action of reducing elevated as well as normal IOP and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry.

12.2 Pharmacodynamics

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. A single dose provides a 12-hour reduction in IOP. In some patients, the IOP lowering responses to BETOPTIC S may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.Ophthalmic betaxolol solution at 1% (one drop in each eye) was compared to placebo in a crossover study challenging nine patients with reactive airway disease. Betaxolol HCl had no significant effect on pulmonary function as measured by Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC and was not significantly different from placebo. The action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol.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.

13.1 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.

14 Clinical Studies

In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of BETOPTIC S Ophthalmic Suspension 0.25% and BETOPTIC S Ophthalmic Solution 0.5% were clinically equivalent. BETOPTIC S Suspension was significantly more comfortable than BETOPTIC Solution.

16 How Supplied/Storage And Handling

BETOPTIC S Ophthalmic Suspension 0.25% is supplied as follows: 10 and 15 mL in plastic ophthalmic DROP-TAINER® dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER® package.10 mL NDC 0065-0246-1015 mL NDC 0065-0246-15Storage and HandlingStore upright at 2°C - 25°C (36°F - 77°F).Shake well before using.

Other

Avoiding Contamination of the ProductInstruct patients to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Also instruct patients that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions.

Intercurrent Ocular ConditionsAdvise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container.

Concomitant Topical Ocular TherapyAdvise patients requiring concomitant topical ophthalmic medications to administer these at least 10 minutes before instilling BETOPTIC S Suspension.

Temporary Blurred VisionVision may be temporarily blurred following dosing with BETOPTIC S Ophthalmic Suspension 0.25%. Care should be exercised in operating machinery or driving a motor vehicle.

Contact Lens WearThe preservative in BETOPTIC S Ophthalmic Suspension 0.25%, benzalkonium chloride, may be absorbed by soft contact lenses. Remove contact lenses during instillation of BETOPIC S Ophthalmic Suspension 0.25%. Contact lenses may be reinserted 15 minutes after instillation.© 2003, 2007- 2009,  2016 NovartisDistributed by:Alcon Laboratories, Inc.Fort Worth, Texas 76134Alcon®a Novartis companyT2017-21March 2017

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