Bayer Plus

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

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

What is the most important information I should know about aspirin?

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, or if you have:

• 
  

  a recent history of stomach or intestinal bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

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

• 
  

  asthma or seasonal allergies;

  
  


• 
  

  stomach ulcers;

  
  


• liver disease;


• kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease, high blood pressure, or congestive heart failure;

  
  


• 
  

  gout; or

  
  


• 
  

  nasal polyps.

  
  

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

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:

• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fever lasting longer than 3 days;

  
  


• 
  

  swelling, or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Less serious side effects may include:

• 
  

  upset stomach, heartburn;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  headache.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking aspirin, tell your doctor if you are using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

  
  

This list is not complete and there may be other drugs that can interact with aspirin. 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.

More Bayer Plus resources

• Bayer Plus Side Effects (in more detail)
• Bayer Plus Use in Pregnancy & Breastfeeding
• Bayer Plus Drug Interactions
• Bayer Plus Support Group
• 1 Review for Bayer Plus - Add your own review/rating

• Aspirin Monograph (AHFS DI)


• Aspirin Prescribing Information (FDA)


• Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information


• ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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• Ischemic Stroke, Prophylaxis
• Juvenile Rheumatoid Arthritis
• Kawasaki Disease
• Myocardial Infarction, Prophylaxis
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• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Rheumatic Fever
• Rheumatoid Arthritis
• Sciatica
• Systemic Lupus Erythematosus
• Thromboembolic Stroke Prophylaxis
• Transient Ischemic Attack

Where can I get more information?

• Your pharmacist can provide more information about aspirin.

See also: Bayer Plus side effects (in more detail)

Betoptic Pilo

Dosage Form: ophthalmic suspension

DESCRIPTION

Betoptic®Pilo Ophthalmic Suspension contains betaxolol hydrochloride, a cardiovascular (beta1) adrenoceptor antagonist and pilocarpine hydrochloride, a cholinergic parasympathomimetic agent.

Betaxolol hydrochloride is a white, crystalline powder. Its chemical name is (±)-1[p-(cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride with an empirical formula of C18H29NO3HCl and a molecular weight of 343.89. The chemical structure of betaxolol hydrochloride is as follows:

Pilocarpine hydrochloride is a white powder. Its chemical name is 2(3H)-furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]-, monohydrochloride, (3S-cis)- with an empirical formula of C11H16N2O2HCl and a molecular weight of 244.72. The chemical structure of pilocarpine hydrochloride is as follows:

Each mL of Betoptic®Pilo Ophthalmic Suspension contains the following:

Active: Betaxolol hydrochloride 2.8 mg equivalent to 2.5 mg betaxolol base and pilocarpine hydrochloride 17.5 mg;

Preservative: Benzalkonium chloride 0.01%.

Inactive: Mannitol, poly(styrene-divinyl benzene) sulfonic acid, carbomer 934P, boric acid, edetate disodium, sodium hydroxide and/or hydrochloric acid to adjust to a pH 6.0-8.0 and purified water.

Betoptic®Pilo Ophthalmic Suspension is provided as a two-part unit for combination by the Pharmacist. It consists of the following components: Part I – a glass syringe containing pilocarpine hydrochloride 8.75%, sodium hydroxide and/or hydrochloric acid (pH 5.0 ± 0.2) and purified water to 1.6 mL; and Part II – a DROP-TAINER® containing betaxolol 0.313%, poly(styrene-divinyl benzene) sulfonic acid, carbomer 934P, boric acid, mannitol, edetate disodium, benzalkonium chloride, sodium hydroxide (pH 8.0 ± 0.2) and purified water to 6.4 mL.

Betoptic®Pilo Ophthalmic Suspension is prepared by affixing a one-inch, blunt, 27 gauge cannula (supplied) to the syringe containing the pilocarpine hydrochloride solution and adding the entire contents of the syringe through the opening in the dropper tip to the DROP-TAINER® containing the betaxolol suspension and mixing well. The final pH of the combination suspension is 6.0 to 8.0

Remove Cap from DropTainer	Add Contents of Syringe through Orifice in DropTainer	Cap and Mix Well. Label with a 2-Week Expiry Period

ADD CONTENTS OF PART I TO PART II AND MIX WELL IMMEDIATELY PRIOR TO DISPENSING AND LABEL WITH A TWO (2) WEEK EXPIRATION DATE

CLINICAL PHARMACOLOGY

Betaxolol hydrochloride, a cardioselective (beta1) adrenoceptor antagonist, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic blocking agents reduce cardiac output in healthy subjects and subjects 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.

Pilocarpine is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic neuroreceptors and smooth muscle such as the iris and secretory glands. Each of these compounds lowers elevated intraocular pressure (IOP) by different mechanisms of action. Betaxolol lowers IOP predominately by decreasing aqueous humor production. Pilocarpine lowers IOP predominantly by increasing the outflow of aqueous humor from the eye.

The efficacy and safety of Betoptic®Pilo Ophthalmic Suspension dosed TID was evaluated in two prospective, multicenter, controlled clinical trials. In both controlled studies, Betoptic®Pilo Ophthalmic Suspension dosed TID provide up to an additional 1-3 mmHg IOP lowering from the BETOPTIC®-S BID baseline. Betoptic®Pilo has not been shown to be superior to any other beta-blocker aside from Betoptic®-S.

The potential for systemic absorption was evaluated following topical use of Betoptic®Pilo Ophthalmic Suspension TID. After five and eight days of dosing with Betoptic®Pilo Ophthalmic Suspension TID, plasma levels of betaxolol were below the level of quantification (2.0 ng/mL) indicating that TID dosing results in a low systemic exposure to the drug. Plasma concentrations of pilocarpine were higher following topical ocular administration of Pilocarpine HCl Solution 4% QID than after dosing with Betoptic®Pilo Ophthalmic Suspension TID.

INDICATIONS AND USAGE

Betoptic®Pilo Ophthalmic Suspension is indicated for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension who are insufficiently responsive to Betoptic®-S (failed to achieve target IOP determined after multiple measurements over time).

It is not known whether Betoptic®Pilo is equivalent in IOP lowering efficacy to the administration of Betoptic®-S 0.25% and pilocarpine 1.75% dosed separately. It is not known whether Betoptic®Pilo is equivalent to other beta-blockers given in combination with pilocarpine.

CONTRAINDICATIONS

Betoptic®Pilo Ophthalmic Suspension is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular heart block, cardiogenic shock or patients with overt cardiac failure.

Betoptic®Pilo Ophthalmic Suspension is also contraindicated in conditions where miosis is undesirable (e.g., peripheral anterior synechia, trauma, acute inflammatory disease of the anterior chamber, glaucoma occurring or persisting after extracapsular cataract extraction when posterior synechia may occur, and papillary block glaucoma).

Hypersensitivity to any component of this product.

WARNINGS

NOT FOR INJECTION OR ORAL ADMINISTRATION. FOR TOPICAL OPHTHALMIC USE ONLY. COMBINE PARTS I AND II PRIOR TO DISPENSING AND LABEL WITH A TWO (2) WEEK EXPIRATION DATE

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.

Betaxolol 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. Betoptic®Pilo Ophthalmic Suspension should be discontinued at the first signs of cardiac failure.

PRECAUTIONS

General

Ocular. Pilocarpine-induced miosis may cause difficulty in dark adaptation. Patients should be advised to exercise caution in night driving and hazardous tasks performed in poor illumination.

In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent. Betoptic®Pilo Ophthalmic Suspension contains pilocarpine HCl 1.75%, a miotic, which, while having an effect on the pupil, is unlikely to be sufficient to effectively treat an angle closure event.

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 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 blockage 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 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 such patients with ophthalmic betaxolol have 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.

Information for Patients

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or disruption of the ocular epithelial surface.

The preservative in Betoptic®Pilo, benzalkonium chloride, may be absorbed by soft contact lenses. Betoptic®Pilo should not be administered while wearing soft contact lenses.

Drug Interactions

Patients who are receiving a beta-adrenergic blocking agent orally and Betoptic®Pilo Ophthalmic Suspension should be observed for a potential additive effect 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 (e.g., reserpine) or calcium-channel blockers because of possible additive effects and the production of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies with betaxolol hydrochloride 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 hydrochloride demonstrated no carcinogenic effect. Higher dose levels were not tested. In a variety of in vitro bacterial and mammalian cell assays, betaxolol hydrochloride was nonmutagenic.

There have been no long-term studies done using pilocarpine in animals to evaluate carcinogenic potential.

Pregnancy

Teratogenic Effects

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 post-implantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. Betaxolol HCl was shown not 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 of betaxolol HCl or pilocarpine in pregnant women. Betoptic®Pilo 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 topical ocular betaxolol, pilocarpine or Betoptic®Pilo Ophthalmic Suspension is excreted in human milk; however, oral betaxolol is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue Betoptic®Pilo Ophthalmic Suspension usage, taking into account the benefit of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

In multi-center controlled clinical trials of Betoptic®Pilo Ophthalmic Suspension the adverse events reported in an approximately 5 to 20% incidence of patients were: headaches, blurred vision, dim vision, abnormal vision, and vitreous disorder.

In the 3-month controlled clinical trials, 12% of patients enrolled on Betoptic®Pilo treatment discontinued the therapy within the first two weeks of treatment because of intolerance due to adverse reactions. In a 24-month long-term safety study, by Month-12, 20% of patients had discontinued and by the Month-24 endpoint, 55% of patients had discontinued Betoptic®Pilo therapy.

The following adverse events were reported at an incidence of 1 to 4% of patients: bronchitis, browache, constipation, dizziness, hyperemia, ocular discomfort, nausea, and pain.

The following adverse events were reported in less than 1% of the patients: abnormal dreams, asthenia, asthma, blepharitis, conjunctival edema, lid erythema, lid margin crusting, lid spasm, palpitation, periorbital edema, photophobia, scotoma, synechiae, and tearing.

In addition, the following adverse events have been associated with ophthalmic formulations containing betaxolol or pilocarpine:

Ocular: Discomfort characterized by burning and stinging upon instillation, ciliary spasm, conjunctival vascular congestion, myopia (especially in younger individuals who have recently started therapy), and reduced visual acuity in poor illumination (frequently experienced by older individuals and individuals with lens opacity), corneal punctate keratitis, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes. Retinal detachments have been reported with the use of miotics such as pilocarpine and cataracts may occur with prolonged use of pilocarpine.

Additional ocular events reported with other formulations of betaxolol or pilocarpine include allergic reactions, decreased corneal sensitivity, edema, anisocoria, lacrimation, and superficial keratitis (corneal granularity).

Systemic: Cardiovascular; Bradycardia, heart block, and congestive heart failure; Pulmonary; Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma, and respiratory failure; Nervous System; Insomnia, dizziness, vertigo, temporal or supraorbital headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis; Other: Hives, toxic epidermal necrolysis, hair loss and glossitis.

Overdosage

No information is available on overdosage of Betoptic®Pilo Ophthalmic Suspension in humans. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic blocking agent are bradycardia, hypotension and acute cardiac failure. Symptoms associated with pilocarpine toxicity include sweating, salivation, gastrointestinal over activity (nausea, vomiting, diarrhea), tremors, bradycardia, hypotension, atrioventricular block, mental status changes, and bronchial constriction (in asthmatic patients).

Dosage and Administration

One or two drops of Betoptic®Pilo Ophthalmic Suspension should be instilled in the affected eye(s) three-times daily.

How Supplied

Betoptic®Pilo Ophthalmic Suspension is supplied as two parts requiring mixing before dispensing. Part I consists of a glass syringe containing pilocarpine hydrochloride sealed in a sterile blister pack also containing a sterile, one inch, blunt, 27 gauge cannula. Part II consists of a DROP-TAINER® containing betaxolol hydrochloride ophthalmic suspension. Once Part I is added into Part II and mixed, the resulting Betoptic®Pilo Ophthalmic Suspension is to be used for no longer than two (2) weeks. At this time, the reconstituted Betoptic®Pilo Ophthalmic Suspension should be replaced.

Storage: Store at 4 – 30°C (40 – 86°F). Shake well before using. Discard reconstituted suspension two (2) weeks after combining.

Caution: Federal ( USA) Law Prohibits Dispensing Without a Prescription.

U.S. Patent No’s.: 4,252,984; 4,311,708; 4,342,783; and 4,911,920

March 26, 1997

Alcon®

Alcon Laboratories, Inc.

Fort Worth, Texas 76134

Betoptic Pilo  betaxolol hydrochloride and pilocarpine hydrochloride  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0850

Packaging # NDC Package Description Multilevel Packaging 1 0065-0850-20 1 KIT In 1 KIT None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, DROPPER   6.4 MILLILITER  in 1  Part 2 1 SYRINGE, GLASS   1.6 MILLILITER  in 1

Part 1 of 2 BETAXOLOL HYDROCHLORIDE  betaxolol hydrochloride  suspension

Product Information       Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Betaxolol Hydrochloride (Betaxolol) Active 2.5 MILLIGRAM  In 1 MILLILITER poly(styrene-divinyl benzene) sulfonic acid Inactive   Carbomer 934P Inactive   Boric acid Inactive   Mannitol Inactive   Edetate Disodium Inactive   Benzalkonium Chloride Inactive   Sodium Hydroxide Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 6.4 mL (MILLILITER) In 1 BOTTLE, DROPPER None

Part 2 of 2 PILOCARPINE HYDROCHLORIDE  pilocarpine hydrochloride  solution

Product Information       Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Pilocarpine Hydrochloride (Pilocarpine) Active 17.5 MILLIGRAM  In 1 MILLILITER Sodium Hydroxide Inactive   Hydrochloric acid Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1.6 mL (MILLILITER) In 1 SYRINGE, GLASS None

Revised: 06/2006Alcon Laboratories, Inc.

More Betoptic Pilo resources

• Betoptic Pilo Side Effects (in more detail)
• Betoptic Pilo Support Group
• 0 Reviews · Be the first to review/rate this drug

beractant

Generic Name: beractant (ber AK tant)

Brand Names: Survanta Intratracheal

What is beractant?

Beractant is made from animal lung extract and contains fatty acids and proteins. It works by reducing the surface tension of fluids inside the human lung to keep the lung from collapsing.

Beractant is used to treat or prevent respiratory distress syndrome (RDS) in newborn infants.

Beractant may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about beractant?

Beractant is given within minutes or hours after the infant is born. The medication must be given in a neonatal intensive care unit (NICU), a specialized setting for premature babies or newborns who need special care.

Your child will require special care in the hospital during treatment with beractant. Talk with your doctor about any special instructions for handling the infant and watching for side effects while beractant is given.

Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant.

What should I discuss with my health care provider before my child receives beractant?

Your child will require special care in the hospital during treatment for RDS. Talk with your doctor about any special instructions for handling the infant and watching for side effects while beractant is given.

How is beractant given?

Beractant is given within minutes or hours after the infant is born. The medication must be given in a neonatal intensive care unit (NICU), a specialized setting for premature babies or newborns who need special care.

This medication is given through an endotracheal (en-doe-TRAY-kee-al) tube. This is a flexible plastic tube placed in the infant's mouth and passed down into the airway. A doctor will insert the tube using a scope to see the inside of the airway while guiding the tube into place.

Beractant is usually given every 6 hours.

To make sure this medication is helping your child's condition and is not causing any harmful effects, your child's lung function will need to be tested often. This will help your doctor determine how long to continue treatment with beractant. Your child may also need blood tests.

What happens if my child misses a dose?

Since beractant is given by healthcare professionals in a hospital setting, it is not likely that your child will miss a dose.

What happens if my child receives an overdose?

Overdose with beractant has not been reported. Because this medication is given by a healthcare professional, it is not likely that your child will receive an overdose.

What should be avoided after my child receives beractant?

Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant.

Beractant side effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat. Tell your child's caregivers at once if the child has any of these serious side effects:

• 
  

  pale skin;

  
  


• 
  

  slow heartbeat;

  
  


• 
  

  breathing that stops;

  
  


• 
  

  urinating less than usual; or

  
  


• 
  

  blood in the urine.

  
  

Less serious side effects include:

• 
  

  noisy breathing;

  
  


• 
  

  feeding or bowel problems; or

  
  


• 
  

  bleeding around the endotracheal tube.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Beractant Dosing Information

Usual Pediatric Dose for Respiratory Distress Syndrome:

>48 hours of life: Safety and efficacy have not been established.

What other drugs will affect beractant?

There may be other drugs that can interact with beractant. However, your child's care providers will be aware of all medications used in your child's treatment. It is not likely that your child will be given other medications that will interact with beractant.

More beractant resources

• Beractant Side Effects (in more detail)
• Beractant Use in Pregnancy & Breastfeeding
• Beractant Support Group
• 0 Reviews for Beractant - Add your own review/rating

• Beractant Professional Patient Advice (Wolters Kluwer)


• Beractant Monograph (AHFS DI)


• Beractant

Compare beractant with other medications

• Respiratory Distress Syndrome

Where can I get more information?

• Your doctor or pharmacist can provide more information about beractant.

See also: beractant side effects (in more detail)

Beta HC

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Beta HC

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Beta HC

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Beta HC. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Beta HC

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Beta HC Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Beta HC side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Beta HC resources

• Beta HC Side Effects (in more detail)
• Beta HC Use in Pregnancy & Breastfeeding
• Beta HC Drug Interactions
• Beta HC Support Group
• 0 Reviews for Beta HC - Add your own review/rating

• Beta HC Concise Consumer Information (Cerner Multum)


• Anucort-HC cream, ointment, suppository Concise Consumer Information (Cerner Multum)


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Concise Consumer Information (Cerner Multum)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Nutracort Concise Consumer Information (Cerner Multum)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Beta HC with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash

Bepotastine Besilate

Class: Antiallergic Agents
Chemical Name: 4-[(S)-(4-chlorophenyl)-2-pyridinylmethoxy]-,benzene sulfonate (1:1); (2) (+)-4-{4-[(S)-(4-Chlorophenyl)(pyridin-2-yl)methoxy]piperidin-1-yl}butanoic acid monobenzenesulfonate.
Molecular Formula: C₂₁H₂₅ClN₂O₃.C₆H₆O₃S.547.10
CAS Number: 190786-44-8
Brands: Bepreve

Introduction

Histamine H ₁-receptor antagonist with mass-cell stabilizing activity.^{1 2 3 5}

Uses for Bepotastine Besilate

Allergic Conjunctivitis

Symptomatic treatment of ocular itching associated with allergic conjunctivitis.^{1 3 7 8 9 10}

Bepotastine Besilate Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.^{1 2 3 5 6}

Remove soft contact lenses prior to administration of each dose (since benzalkonium chloride may be absorbed by the lenses); may reinsert lenses after 10 minutes following administration if eyes are not red.^{1 5}

Avoid contamination of the solution container.^{1 5}

Dosage

Available as bepotastine besilate; dosage expressed in terms of the salt.¹

Pediatric Patients

Allergic Conjunctivitis

Ophthalmic

Children ≥2 years of age: 1 drop of a 1.5% solution in the affected eye(s) twice daily.¹

Adults

Allergic Conjunctivitis

Ophthalmic

1 drop of a 1.5% solution in the affected eye(s) twice daily.^{1 5}

Cautions for Bepotastine Besilate

Contraindications

• 
  

  Manufacturer states none known.¹

  
  

Warnings/Precautions

Administration

For topical ophthalmic use only.¹

Proper Handling to Avoid Contamination

To avoid contamination of the dropper tip and solution, do not to touch the eyelids or surrounding areas with the dropper tip.¹

Close container tightly when not in use.¹

Contact Lenses

Remove contact lenses prior to administration of each dose, since benzalkonium chloride preservative may be absorbed by soft contact lenses; lenses may be reinserted after 10 minutes following administration if eyes are not red; patient should not wear contact lenses if eyes are red.^{1 5} Not indicated for contact lens-related ocular irritation.^{1 5}

Specific Populations

Pregnancy

Category C.^{1 5}

Lactation

Distributed into milk in rats following oral administration.¹

Not known whether bepotastine besilate distributes into human milk following topical application to the eye.¹ Use caution.¹

Pediatric Use

Safety and efficacy not established in pediatric patients <2 years of age.¹ Efficacy in pediatric patients <10 years of age was extrapolated from clinical trials conducted in pediatric patients >10 years of age and adults.¹

Geriatric Use

No overall differences in efficacy or safety observed between geriatric and younger patients.¹

Common Adverse Effects

Mild taste following instillation,^{1 3 6} ocular irritation, headache, nasopharyngitis.^{1 2 3 10}

Interactions for Bepotastine Besilate

Minimally metabolized by CYP isoenzymes.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Low potential for drug interactions via inhibition of CYP isoenzymes 3A4, 2C9, and 2C19.¹

Effect on metabolism of substrates of CYP isoenzymes 1A2, 2C8, and 2D6 not established.¹

Bepotastine Besilate Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations achieved approximately 1–2 hours after instillation.¹

Distribution

Plasma Protein Binding

Approximately 55%.¹

Elimination

Metabolism

Minimally metabolized by CYP isoenzymes.¹

Elimination Route

Excreted principally in urine as unchanged drug (75–90%).¹

Stability

Storage

Ophthalmic

Solution

15–25°C.¹

ActionsActions

• 
  

  Inhibits the release of histamine and other mediators (e.g., leukotrienes, platelet activating factor [PAF]) involved in allergic reactions.^{1 2 3 5}

  
  


• 
  

  Exhibits mast-cell stabilizing activity.^{1 2 3 5}

  
  


• 
  

  Inhibits eosinophil migration to and activation at inflammatory sites.²

  
  

Advice to Patients

• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the solution.^{1 5}

  
  


• 
  

  Importance of removing contact lenses prior to administration of each ophthalmic dose, since benzalkonium chloride preservative may be absorbed by soft lenses; may reinsert contact lenses after 10 minutes following administration if eyes are not red; importance of not wearing contact lenses if eyes are red.^{1 5}

  
  


• 
  

  Not indicated for contact lens-related ocular irritation.^{1 5}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.

  
  


• 
  

  (See Cautions.)¹

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Bepotastine Besilate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	1.5%	Bepreve	Ista

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bepreve 1.5% Solution (ISTA PHARMACEUTICALS): 10/$189.98 or 30/$529.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Ista Pharmaceuticals. Bepreve(bepotastine besilate) ophthalmic solution prescribing information. Irvine, CA; 2009 Aug. (

2. Abelson MB, Torkildsen GL, Williams JI et al. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solution 1.0% and 1.5% in allergic conjunctivitis: a phase III, single-center, prospective, randomized, double-masked, placebo controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther. 2009; 31:1908-21. [PubMed 19843481]

3. Anon. Bepotastine (Bepreve)—An ophthalmic H₁ antihistamine. Med Lett. 2010; 52:8-12.

4. Protzko EE, Gomes PJ, Williams JI et al. The ocular comfort and safety of the novel anti-Histamine bepotastine besilate ophthalmic solution 1.5% in a healthy pediatric population. J Allergy Clin Immunol. 2009; (Suppl 2): S50.

5. Hussar DA, Abbas CA. New drugs: asenapine, iloperidone, and bepotastine besilate. J Am Pharm Assoc. 2010; 50:107-10.

6. Gow JA, Protzko EE, Gomes PJ et al. Safety of the antihistamine bepotastine besilate ophthalmic solution in a healthy pediatric population from 3 to 9 years of age. Poster presented at: 35th Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery. San Francisco, CA: 2009 April 4-8. Abstract 559458.

7. Meier EJ, Macejko TT, Bergmann MT et al. Bepotastine besilate ophthalmic solution 1.0% provides rapid relief of rhinorrhea, total non-ocular symptoms, tearing, and ciliary and episcleral hyperemia following dosing in a multi-site clinical model of allergic conjunctivitis. J Allergy Clin Immunol. 2009; 123 (Suppl): S57.

8. Torkildsen GL, Gomes PJ, Williams JI et al. Bepotastine besilate ophthalmic solution 1.5% reduces ocular itching in a clinical model of allergic conjunctivitis. J Allergy Clin Immunol. 2009; 123 (Suppl): S57.

9. Macejko TT, Meier EJ, Bergmann MT et al. Bepotastine besilate ophthalmic solution 1.5% for up to 8 hours following dosing reduces total non-ocular symptoms, rhinorrhea, and tearing in a multi-site clinical model of allergic conjunctivitis. J Allergy Clin Immunol. 2009; 123 (Suppl):S57.

10. Bergmann MT, Gomes PJ, Williams JI et al. Bepotastine besilate ophthalmic solution 1.5% reduces ocular itching in a multisite clinical model of allergic conjunctivitis. Poster presented at the 35th Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery. San Francisco, CA: 2009 April 4-8. Abstract 559520.

11. ISTA Pharmaceuticals, Irvine, CA: Personal communication.

12. Wadhwa SD. Medical review(s) for bepotastine besilate ophthalmic solution 1.5% (Bepreve), application number 22-228. Rockville, MD: US Food and Drug Administration; 2009 Apr 27. From FDA website ().

More Bepotastine Besilate resources

• Bepotastine Besilate Side Effects (in more detail)
• Bepotastine Besilate Dosage
• Bepotastine Besilate Use in Pregnancy & Breastfeeding
• Bepotastine Besilate Support Group
• 10 Reviews for Bepotastine Besilate - Add your own review/rating

Compare Bepotastine Besilate with other medications

• Conjunctivitis, Allergic

Betagan

Generic Name: levobunolol (Ophthalmic route)

lee-voe-BUE-noe-lol

Commonly used brand name(s)

In the U.S.

• Betagan

In Canada

• Ratio-Levobunolol

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For Betagan

Levobunolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .

This medicine is available only with your doctor's prescription .

Before Using Betagan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of levobunolol in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of levobunolol in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol


• Amiodarone


• Arformoterol


• Bambuterol


• Bitolterol


• Broxaterol


• Clenbuterol


• Colterol


• Diltiazem


• Dronedarone


• Epinephrine


• Fenoldopam


• Fenoterol


• Formoterol


• Hexoprenaline


• Indacaterol


• Isoetharine


• Levalbuterol


• Metaproterenol


• Pirbuterol


• Procaterol


• Reproterol


• Rimiterol


• Ritodrine


• Salmeterol


• Terbutaline


• Tretoquinol


• Tulobuterol


• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Aceclofenac


• Acemetacin


• Acetohexamide


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Carprofen


• Chlorpropamide


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Doxazosin


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Ibuprofen


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Mibefradil


• Miglitol


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propyphenazone


• Proquazone


• Repaglinide


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Trimazosin


• Troglitazone


• Urapidil


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Bradycardia (slow heartbeat) or


• Chronic obstructive pulmonary disease (COPD), severe or


• Heart block or


• Heart failure—Should not use in patients with these conditions .

• Blood vessel disease (especially blood vessels in the brain) or


• Stroke, history of—Use with caution. This medicine may worsen these conditions .

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Lung disease—Use with caution. May cause difficulty with breathing in patients with this condition .

• Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness .

• Sulfite allergy—Use with caution. This medicine contains a small amount of sodium metabisulfite .

Proper Use of levobunolol

This section provides information on the proper use of a number of products that contain levobunolol. It may not be specific to Betagan. Please read with care.

Shake the medicine well just before each use .

To use the eye drops (solution):

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the medicine, wash your hands to remove any medicine that may be on them.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .

If your doctor ordered two different eye medicines to be used together, wait several minutes before using the second medicine. This will help prevent the second medicine from “washing out” the first one .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution dosage form (eye drops):
  
  • For glaucoma or ocular hypertension:
    
    • Adults—One to two drops in the affected eye(s) once a day. Your doctor may increase your dose to 1 to 2 drops two times a day, if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Betagan

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .

Levobunolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

Betagan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning or stinging in eye


• drainage from the eye


• redness, swelling, and/or itching of eye and eyelid

Less common

• Blurred vision


• chest pain or discomfort


• confusion


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• shortness of breath


• slow or irregular heartbeat


• sweating


• unusual tiredness or weakness

Rare

• Eye pain


• headache


• hives or welts


• itching skin


• redness of skin


• shakiness and unsteady walk


• skin rash


• tearing


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual drowsiness, dullness, or feeling of sluggishness

Incidence not determined

• Blistering, peeling, loosening of skin


• blue lips, fingernails, or skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chills


• cough


• decreased urine output


• diarrhea


• difficult or labored breathing


• difficulty in chewing, swallowing, or talking


• dilated neck veins


• disturbed color perception


• double vision


• drooping eyelids


• extreme fatigue


• fast, pounding, or racing heartbeat or pulse


• fever


• halos around lights


• hoarseness


• inability to speak


• irregular, fast or slow, or shallow breathing


• irritation


• joint pain, stiffness, or swelling


• muscle pain


• muscle weakness


• night blindness


• no blood pressure or pulse


• noisy breathing


• overbright appearance of lights


• red skin lesions, often with a purple center


• seeing double


• seizures


• severe numbness, especially on one side of the face or body


• severe or sudden headache


• severe tiredness


• slurred speech


• sore throat


• sores, ulcers, or white spots in mouth or on lips


• stopping of heart


• swelling of eyelids, face, lips, hands, fingers, feet, or lower legs


• temporary blindness


• tightness in chest


• troubled breathing


• tunnel vision


• unconsciousness


• weakness in arm and/or leg on one side of the body, sudden and severe


• weight gain


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not determined

• Decreased interest in sexual intercourse


• discouragement


• feeling sad or empty


• inability to have or keep an erection


• irritability


• lack of appetite


• lack or loss of strength


• loss in sexual ability, desire, drive, or performance


• loss of interest or pleasure


• nausea


• stuffy nose


• tiredness


• trouble concentrating


• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Betagan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Betagan resources

• Betagan Side Effects (in more detail)
• Betagan Use in Pregnancy & Breastfeeding
• Betagan Drug Interactions
• Betagan Support Group
• 0 Reviews for Betagan - Add your own review/rating

• Betagan Prescribing Information (FDA)


• Betagan Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Betagan Concise Consumer Information (Cerner Multum)


• Betagan Monograph (AHFS DI)


• Levobunolol Prescribing Information (FDA)


• Levobunolol Professional Patient Advice (Wolters Kluwer)

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