LEVALBUTEROL (Inhalation-Local)

Some commonly used brand names are:

In the U.S.?

• Xopenex
• Xopenex HFA

Category

• Bronchodilator, adrenergic (inhalation-local)

Description

Levalbuterol (lee-val-BYOO-ter-ole)belongs to the family of adrenergic bronchodilators. Levalbuterol is usedto prevent or treat chest tightness, shortness of breath, troubled breathingand wheezing associated with bronchospasm.

This medicine is breathed in through the mouth by using a nebulizer andcompressor or by using an inhaler. Levalbuterol opens up the bronchial tubes(air passages) of the lungs.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Inhalation
• Aerosol (U.S.)
• Solution (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to levalbuterol, albuterol, or other inhaled asthma medicines.Also tell your health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Levalbuterol has not been studied in pregnant women.However, studies in animals have shown that albuterol, a very similar medicine,may cause birth defects or other problems. Levalbuterol has the potentialto interfere with contractions during labor. Levalbuterol should not be usedfor preterm labor. Before taking this medicine, make sure your doctor knowsif you are pregnant or may become pregnant.

Breast-feeding?It is not known whether levalbuterol passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.

Children?The inhalation solution has been tested in children12 years of age and older. The inhalation aerosol has been tested in children4 years of age and older. In effective doses, this medicine has not been shownto cause different side effects or problems than it does in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same as they do in young adults. Although there is limited informationcomparing the use of levalbuterol in the elderly with use in other age groups,this medicine is not expected to cause different side effects or problemsin older people than it does in younger adults. Your doctor may want to beginwith a lesser dose and increase the dosage as tolerated.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your doctor andpharmacist if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicines, including the following:

• Aerosol bronchodilators, short-acting (albuterol [e.g., Proventil,Ventolin], bitolterol [e.g., Tornalate], ephedrine [OTC], epinephrine [OTC,e.g., Primatene], isoetharine [e.g., Bronkosol], isoproterenol [e.g., Isuprel],pirbuterol [e.g., Maxair], terbutaline [e.g., Brethaire])?Using levalbuterolwhile you are using short-acting aerosol bronchodilators may cause some heartproblems

• Beta-adrenergic blocking agents, systemic (acebutolol [e.g., Sectral],atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], carteolol [e.g., Cartrol],labetolol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g.,Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol[e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace, Sotacor],timolol [e.g., Blocadren])?Using levalbuterol while you are using beta-adrenergicblocking agents may block the relaxation of smooth muscle in the lungs toease breathing

• Digoxin?Levalbuterol may decrease the levels of digoxin inthe blood. Blood levels of digoxin should be monitored when possible

• Diuretics, non-potassium-sparing (bumetanide [e.g., Bumex],ethacrynic acid [e.g., Edecrin], furosemide [e.g., Lasix], indapamide [e.g.,Lozol], thiazide diuretics [water pills])?Use may worsen salt imbalancein the blood

• Methylxanthines (caffeine, theophylline [e.g., Theo-Dur])?Usinglevalbuterol with methylxanthines may result in irregular heartbeat

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline[e.g., Eldepryl], tranylcypromine [e.g., Parnate]) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin,Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline[e.g., Aventyl, Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g.,Surmontil])?Taking levalbuterol while you are taking, or within 2 weeksof taking, MAO inhibitors or tricyclic antidepressants may cause a changein blood pressure or pulse rate

Other medical problems?The presence of other medicalproblems may affect the use of levalbuterol. Make sure you tell your doctorif you have any other medical problems, especially:

• Heart disease (irregular heartbeat or decreased blood flow throughthe heart) or
• High blood pressure?Use of levalbuterol may worsen these conditions

• Diabetes mellitus (sugar diabetes)?Levalbuterol may worsenblood glucose control

• Hyperthyroidism (overactive thyroid)

• Seizures?Concurrent use may worsen this condition

Proper Use of This Medicine

These medicines come with patient directions. Read them carefully before usingthe medicine. If you do not understand the directions or if you arenot sure how to use the medicine, ask your health care professional to showyou what to do. Also, ask your health care professional to check regularlyhow you use the medicine to make sure you are using it properly.

Use this medicine only as directed. Do not use moreof it and do not use it more often than recommended on the label, unless otherwisedirected by your doctor. Using the medicine more often may increasethe chance of serious unwanted effects. Deaths have occurred when too muchof an inhalation bronchodilator medicine was used.

For patients using levalbuterol inhalation aerosol:

• The levalbuterol aerosol canister provides about 200 inhalations,depending on the size of the canister your doctor ordered. You should tryto keep a record of the number of inhalations you use so you will know whenthe canister is almost empty. This canister, unlike some other aerosol canisters,cannot be floated in water to test its fullness.
• When you use the inhaler for the first time, or if you have not usedit in a while, the inhaler may not deliver the right amount of medicine withthe first puff. Therefore, before using the inhaler, test or prime it.
• To test or prime the inhaler:
  • Shake the inhaler well immediately before each use.
  • Take the cap off the actuator (or mouthpiece). Inspect the actuatorfor the presence of foreign objects and make sure that the canister is seatedin the actuator before each use.
  • Prime the inhaler by releasing 4 test sprays in the air, away fromyour face. The inhaler will now be ready to provide the right amount of medicinewhen you use it.
• To use the inhaler:
  • Shake the inhaler well
  • Breathe out fully through your mouth, expelling as much air fromyour lungs as possible. Place the mouthpiece fully into your mouth, holdingthe inhaler in the mouthpiece-down position and closing your lips around it.
  • While breathing in deeply and slowly through your mouth, fully depressthe top of the metal canister with your middle finger. Immediately after thepuff is delivered, release your finger from the canister and remove the inhalerfrom your mouth.
  • Hold your breath for 10 seconds, if possible.
  • If your doctor has prescribed more than a single inhalation/puff,wait 1 minute between inhalations. Then, shake the inhaler well and repeat.
  • Replace the cap on the mouthpiece after each use
  • Clean the actuator or mouthpiece at least once a week.

• To clean the inhaler:
  • To clean the blue plastic actuator (or mouthpiece), remove the canisterand red mouthpiece cap.
  • Wash the actuator through the top and bottom with warm running waterfor 30 seconds at least once a week
  • Shake off the excess water and let the inhaler parts air dry completelybefore putting the inhaler back together.
  • Do not clean the metal canister or allow the metalcanister to become wet. Never immerse the metal canister in water.
  • To dry, shake off excess water and let the actuator air dry thoroughly,such as overnight.
  • When the actuator is dry, replace the canister and the mouthpiececap. Make sure the canister is fully and firmly inserted into the actuator.Blockage from medicine build-up is more likely to occur if the actuator isnot allowed to air dry thoroughly.

For patients using levalbuterol inhalation solutiondosage form:

• If you are using this medicine in a nebulizer,make sure you understand exactly how to use it. If you have any questionsabout this, check with your health care professional.
• Do not use if solution becomes cloudy.
• Do not mix another inhalation medicine with levalbuterolin the nebulizer unless told to do so by your health care professional.

Dosing?The dose of levalbuterol will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of levalbuterol. If your dose is different,do not change it unless your doctor tells you to do so.

• For inhalation aerosol dosage form:
  • For preventing or treating bronchospasm:
    • Adults and children 4 years of age and older?This medicineis used in an aerosol inhaler The usual dose is 2 inhalations (puffs) every4 to 6 hours. In some patients 1 inhalation (puff) every 4 hours may be enough.
    • Children up to 4 years of age?Use and dose must be determinedby your doctor.

• For inhalation solution dosage form:
  • For preventing or treating bronchospasm:
    • Adults and children 12 years of age and older?This medicineis used in a nebulizer and is taken by inhalation over a period of five tofifteen minutes. The usual dose is 0.63 milligrams (mg) to 1.25 mg three timesa day, every six to eight hours.
    • Children up to 12 years of age?Use and dose must be determinedby your doctor.

Missed dose?If you miss a dose of this medicine, use it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

If your dosing schedule is different from all of the above and you missa dose of this medicine, or if you have any questions about this, check withyour doctor.

Storage?To store the inhalation solution of thismedicine:

• Keep out of the reach of children.
• Store away from heat and direct light, in the foil pouch.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
• Once a foil pouch is opened, use the medicine within 2 weeks.

To store the inhalation aerosol of this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light
• The contents of the inhaler are under pressure. Do not puncture orincinerate. Do not expose the inhaler to temperatures above 120 ?F asit may burst.
• Do not freeze
• Do not allow the metal canister to get wet or be immersed in water
• Do not use interchange mouthpieces from other inhalers with the mouthpiecefor this inhaler.
• The canister should be discarded when 200 inhalations (puffs) havebeen used.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It isimportant that your doctor check your progress at regular intervals to makesure that your medicine is working properly.

If you still have trouble breathing after usingthis medicine, if your condition becomes worse, or if you are using more medicinethan the amount prescribed, check with your doctor at once.

Do not add or stop taking inhaled or other asthma medicineswithout first checking with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 as soon as possibleif any of the following side effects occur:

More common

Fast heartbeat

Less common or rare

Chest pain or tightness; dizziness; feeling ?faint?; high orlow blood pressure; hives; light-headedness; shortness of breath; troubled breathing; wheezing

Incidence not known

Cough; Difficult or labored breathing; difficulty swallowing; extra heartbeats; fainting; fast, pounding, slow, or irregular heartbeat or pulse; hives or welts; itching; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs,feet, sex organs; noisy breathing; palpitations; puffiness or swelling of the eyelidsor around the eyes, face, lips, or tongue; rash; redness of skin; tightness in chest; unusual tiredness or weakness

Symptoms of overdose

Chest pain; dizziness; dry mouth; fatigue; general feeling of discomfort or illness; headache; high blood pressure; impaired consciousness; irregular or fast heartbeat; light-headedness; nausea; nervousness; seizures; sleeplessness; sweating; tremor

Other side effects may occur that usually do not needmedical attention. These side effects may go away during treatment as yourbody adjusts to the medicine. Also your health care professional may be ableto tell you about ways to prevent or reduce some of these side effects. Checkwith your health care professional if any of the following side effects continueor are bothersome or if you have any questions about them:

More common

Accidental injury (in children 4 to 11 years of age); anxiety; body aches or pain; chills; congestion; cough or hoarseness; dryness or soreness of throat; fever; general aches andpains; headache; hoarseness; increased cough; leg cramps; loss of appetite; migrainesor other headaches; muscle tightness; nervousness; runny or stuffy nose

Less common or rare

Abdominal or stomach pain; abnormalgrowth filled with fluid or semisolid material; blemishes on the skin; blood in urine; bloody nose; burning, dry or itchingeyes; burning or stinging of skin; cough producing mucus; cramps; diarrhea; difficulty breathing; difficulty having a bowel movement (stool); dischargefrom the eye; dry mouth or throat; ear pain; excessive tearing; eye itch; heavy menstrual bleeding; muscle pain; nausea; night sweats; numbness or decreased sensitivity ofthe hand; pain; painfulcold sores or blisters on lips, nose, eyes, or genitals; pimples; redness, pain, swelling of eye, eyelid,or inner lining of eyelid; sleeplessness; tingling sensation in extremities; vaginal yeast infection; weight loss

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.

Additional Information

Other than the above information,there is no additional information relating to proper use, precautions, orside effects for use in preventing or treating bronchospasm.