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|Xopenex HFA Inhalation-Local

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 used to prevent or treat chest tightness, shortness of breath, troubled breathing and wheezing associated with bronchospasm.

This medicine is breathed in through the mouth by using a nebulizer and compressor 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 the following 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 following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic 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 potential to interfere with contractions during labor. Levalbuterol should not be used for preterm labor. Before taking this medicine, make sure your doctor knows if you are pregnant or may become pregnant.

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

Children—The inhalation solution has been tested in children 12 years of age and older. The inhalation aerosol has been tested in children 4 years of age and older. In effective doses, this medicine has not been shown to cause different side effects or problems than it does in other age groups.

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

Other 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 doctor and pharmacist 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 levalbuterol while you are using short-acting aerosol bronchodilators may cause some heart problems

• 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-adrenergic blocking agents may block the relaxation of smooth muscle in the lungs to ease breathing

• Digoxin—Levalbuterol may decrease the levels of digoxin in the 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 imbalance in the blood

• Methylxanthines (caffeine, theophylline [e.g., Theo-Dur])—Using levalbuterol 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 weeks of taking, MAO inhibitors or tricyclic antidepressants may cause a change in blood pressure or pulse rate

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

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

• Diabetes mellitus (sugar diabetes)—Levalbuterol may worsen blood 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 using the medicine. If you do not understand the directions or if you are not sure how to use the medicine, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the medicine to make sure you are using it properly.

Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects. Deaths have occurred when too much of 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 try to keep a record of the number of inhalations you use so you will know when the 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 used it in a while, the inhaler may not deliver the right amount of medicine with the 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 actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use.
  • Prime the inhaler by releasing 4 test sprays in the air, away from your face. The inhaler will now be ready to provide the right amount of medicine when you use it.
• To use the inhaler :
  • Shake the inhaler well
  • Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece-down position and closing your lips around it.
  • While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is delivered, release your finger from the canister and remove the inhaler from 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 canister and red mouthpiece cap.
  • Wash the actuator through the top and bottom with warm running water for 30 seconds at least once a week
  • Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together.
  • Do not clean the metal canister or allow the metal canister 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 mouthpiece cap. 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 is not allowed to air dry thoroughly.

For patients using levalbuterol inhalation solution dosage form:

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

Dosing—The dose of levalbuterol 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 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 medicine is used in an aerosol inhaler The usual dose is 2 inhalations (puffs) every 4 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 determined by your doctor.

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

Missed dose—If you miss a dose of this medicine, use 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. Do not double doses.

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

Storage—To store the inhalation solution of this medicine:

• 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 sure that 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 or incinerate. Do not expose the inhaler to temperatures above 120 °F as it 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 mouthpiece for this inhaler.
• The canister should be discarded when 200 inhalations (puffs) have been used.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular intervals to make sure that your medicine is working properly.

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

Do not add or stop taking inhaled or other asthma medicines without first checking with your doctor .

Side Effects of This Medicine

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.

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

Additional Information

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

Revised: 03/25/2005

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