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USP DI Vol. II - BRONCHODILATORS,ADRENERGIC (Inhalation)

BRONCHODILATORS,ADRENERGIC (Inhalation)*


Some commonly used brand names are:

In the U.S.?

  • Adrenalin Chloride 3
  • Airet 1
  • Alupent 8
  • Arm-a-Med Isoetharine 6
  • Arm-a-Med Metaproterenol 8
  • Asthmahaler Mist 3
  • AsthmaNefrin 3
  • Beta-2 6
  • Brethaire 12
  • Bronkaid Mist 3
  • Bronkaid Suspension Mist 3
  • Bronkometer 6
  • Bronkosol 6
  • Dey-Lute Isoetharine 6
  • Dey-Lute Metaproterenol 8
  • Foradil 5
  • Isuprel 7
  • Isuprel Mistometer 7
  • Maxair 9
  • Maxair Autohaler 9
  • Medihaler-Iso 7
  • microNefrin 3
  • Nephron 3
  • Primatene Mist 3
  • Proventil 1
  • Proventil HFA 1
  • S-2 3
  • Serevent Diskus 11
  • Vaponefrin 3
  • Ventolin 1
  • Ventolin HFA 1
  • Ventolin Nebules 1
  • Ventolin Rotacaps 1

Note:

Bitolterol was withdrawn from the U.S. market by Elan Pharmaceuticalsin November 2001.

# Salmeterol xinafoate with chlorofluorocarbons(CFCs) as an inhalation aerosol was voluntarily withdrawn from the U.S. marketby GlaxoSmithKline on 06/2003.

In Canada?

  • Alupent 8
  • Apo-Salvent 1
  • Berotec 4
  • Bricanyl Turbuhaler 12
  • Bronkaid Mistometer 3
  • Foradil 5
  • Gen-Salbutamol Sterinebs P.F. 1
  • Isuprel 7
  • Isuprel Mistometer 7
  • Maxair 9
  • Novo-Salmol 1
  • Oxeze Turbuhaler 5
  • Pro-Air 10
  • Serevent 11
  • Serevent Diskhaler 11
  • Serevent Diskus 11
  • Vaponefrin 3
  • Ventodisk 1
  • Ventolin 1
  • Ventolin Nebules P.F. 1
  • Ventolin Rotacaps 1

Other commonly used names are:

  • Adrenaline
  • Orciprenaline
  • Salbutamol

Note:

For quick reference, the following adrenergic bronchodilators arenumbered to match the corresponding brand names.

This information applies to the following medicines:
1.Albuterol (al-BYOO-ter-ole)??
2.Bitolterol (bye-TOLE-ter-ole)*?
3.Epinephrine (ep-i-NEF-rin)?
4.Fenoterol (fen-OH-ter-ole)*
5.Formoterol (for-MOH-ter-ol))??
6.Isoetharine (eye-soe-ETH-a-reen)??
7.Isoproterenol (eye-soe-proe-TER-e-nole)?
8.Metaproterenol (met-a-proe-TER-e-nole)?
9.Pirbuterol (peer-BYOO-ter-ole)
10.Procaterol (proe-KAY-ter-ole)*
11.Salmeterol# (sal-ME-te-role)*
12.Terbutaline (ter-BYOO-ta-leen)
* Not commercially available in the U.S.
? Not commercially available in Canada
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

* Not commercially available in the U.S.


Category

  • Bronchodilator?Albuterol; Bitolterol; Epinephrine; Fenoterol; Formoterol; Isoetharine; Isoproterenol; Metaproterenol; Pirbuterol; Procaterol; Racepinephrine; Salmeterol; Terbutaline
  • Croup therapyagent?Epinephrine

Description

Adrenergic bronchodilatorsare medicines that are breathed in through the mouth to open up the bronchialtubes (air passages) of the lungs. Some of these medicines are used to treatthe symptoms of asthma, chronic bronchitis, emphysema, and other lung diseases,while others are used to prevent the symptoms.

Salmeterol is a long-acting bronchodilator that is used with anti-inflammatorymedication to prevent asthma attacks. Salmeterol is differentfrom the other adrenergic bronchodilators because it does not act quicklyenough to relieve an asthma attack that has already started.

Some of these medicines are also breathed in through the mouth to preventbronchospasm (wheezing or difficulty in breathing) caused by exercise. Also,epinephrine may be used in the treatment of croup.

All of these medicines, except some epinephrine preparations, are availableonly with your doctor's prescription. Although some of the epinephrine preparationsare available without a prescription, your doctor may have special instructionson the proper dose of epinephrine for your medical condition.

These medicines are available in the following dosage forms:

    Inhalation
  • Albuterol
    • Inhalation aerosol (U.S. and Canada)
    • Inhalation solution (U.S. and Canada)
    • Powder for inhalation (U.S. and Canada)
  • Bitolterol
    • Inhalation aerosol (Not commercially available)
    • Inhalation solution (Not commercially available)
  • Epinephrine
    • Inhalation aerosol (U.S. and Canada)
    • Inhalation solution (U.S. and Canada)
  • Fenoterol
    • Inhalation aerosol (Canada)
    • Inhalation solution (Canada)
  • Formoterol
    • for inhalation (U.S. and Canada)
  • Isoetharine
    • Inhalation aerosol (U.S.)
    • Inhalation solution (U.S.)
  • Isoproterenol
    • Inhalation aerosol (U.S. and Canada)
    • Inhalation solution (U.S. and Canada)
  • Metaproterenol
    • Inhalation aerosol (U.S. and Canada)
    • Inhalation solution (U.S. and Canada)
  • Pirbuterol
    • Inhalation aerosol (U.S. and Canada)
  • Procaterol
    • Inhalation aerosol (Canada)
  • Salmeterol
    • Inhalation aerosol (U.S. and Canada)
    • Powder for inhalation (U.S. and Canada)
  • Terbutaline
    • Inhalation aerosol (U.S. and Canada)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to albuterol, bitolterol, epinephrine, fenoterol, formoterol,isoetharine, isoproterenol, metaproterenol, pirbuterol, procaterol, salmeterol,terbutaline, or other inhalation medicines. Also tell your health care professionalif you are allergic to sulfites, which may be used as a preservative in someof these medicines or to lactose, contained in powders for inhalation.

Pregnancy?

  • For albuterol, bitolterol, formoterol, metaproterenol,and salmeterol: These medicines are used to treat asthma in pregnantwomen. Although there are no studies on birth defects in humans, problemshave not been reported. Some studies in animals have shown that they causebirth defects when given in doses many times higher than the human dose. Beforetaking these medicines, make sure your doctor knows if you are pregnant orif you may become pregnant.
  • For epinephrine: Women given epinephrinesubcutaneously (under the skin) during pregnancy have been studied. The babiesof these women had more birth defects than expected, although the severityof the mother's asthma may have contributed to this result.
  • For fenoterol, isoproterenol, pirbuterol, procaterol,and terbutaline: These medicines are used to treat asthma in pregnantwomen. Although there are no studies on birth defects in humans, problemshave not been reported. These medicines have not been shown to cause birthdefects in animal studies when given in doses many times higher than the humandose.
  • For isoetharine: Studies on birth defectshave not been done in either humans or animals.

Breast-feeding?

  • It is not known whether these medicines pass into the breast milk.Although most medicines pass into breast milk in small amounts, many of themmay be used safely while breast-feeding. Mothers who are using these medicinesand who wish to breast-feed should discuss this with their doctor.

Children?Appropriate studies performed to date have not demonstratedpediatrics-specific problems that would limit the usefulness of these medicinesin children. However, isoetharine is not recommended for use in children.

Older adults?

  • For albuterol, bitolterol, epinephrine, fenoterol,isoetharine, isoproterenol, metaproterenol, pirbuterol, procaterol, and terbutaline: These medicines have not been studied specifically in older people.Therefore, it may not be known whether they work exactly the same way theydo in younger adults or if they cause different side effects or problems inolder people. There is no specific information comparing use of inhalationadrenergic bronchodilators in the elderly with use in other age groups.
  • For salmeterol: This medicine has beentested in a limited number of patients 65 years of age or older. It has notbeen shown to cause different side effects or problems in older people thanit does in younger adults.

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. When you are usinginhalation adrenergic bronchodilators, it is especially important that yourhealth care professional know if you are taking any of the following:

  • Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol[e.g., Tenormin], betaxolol [e.g., Kerlone], carteolol [e.g., Cartrol], labetalol[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., Sotacor], timolol [e.g., Blocadren])?Thesemedicines may make your condition worse and prevent the adrenergic bronchodilatorsfrom working properly
  • Disopyramide,
  • Quinidine,
  • Phenothiazines, or
  • Procainamide?These medicines may increase the risk of heartproblems.

Other medical problems?The presence of other medicalproblems may affect the use of inhalation adrenergic bronchodilators. Makesure you tell your doctor if you have any other medical problems, especially:

  • Heart or blood vessel disease?These medicines may make theseconditions worse.
  • High blood pressure, not well controlled?Epinephrine may makethis condition worse.
  • Overactive thyroid or
  • Pheochromocytoma, diagnosed or suspected?The chance of sideeffects may be increased.

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 muchinhalation bronchodilator medicine was used.

Keep the spray away from your eyes because it may cause irritation.

Salmeterol and formoterol are used to prevent asthmaattacks. They are not used to relieve an attack that has already started.For relief of an asthma attack that has already started, you should use anothermedicine (not formoterol) that starts working faster than salmeterol does. If you do not have another medicine to use for an attackor if you have any questions about this, check with your doctor. Becausethe effects of salmeterol and formoterol usually last about 12 hours, dosesshould never be taken more than two times a day or less than 12 hours apart.

Salmeterol and formoterol are not substitutes for youroral or inhaled corticosteroid medicine. If you begin taking salmeterolor formoterol, the dosage of your corticosteroid medicine should not be changedor stopped even if you begin to feel better. If you haveany questions about this, check with your doctor.

Some epinephrine preparations are availablewithout a doctor's prescription. However, do not usethis medicine unless you are seeing a doctor about asthma. Do not use thismedicine if you have been hospitalized for asthma treatment or if youare taking a prescription medicine for asthma, unless you have been toldto do so by a doctor.

When you use the inhaler for the first time, or if you have not used itin a while, the inhaler may not deliver the right amount of medicine withthe first puff. Therefore, before using the inhaler, you may have to testor prime it.

  • To test or prime most inhalers:
    • Insert the medicine container (canister) firmly into the clean mouthpieceaccording to the manufacturer's directions. Check to make sure it is placedproperly into the mouthpiece.
    • Take the cap off the mouthpiece and shake the inhaler three or fourtimes.
    • Hold the inhaler well away from you at arm's length and press thetop of the canister, spraying the medicine into the air two times. The inhaler will now be ready to provide the right amountof medicine when you use it.
  • To use most inhalers:
    • Using your thumb and one or two fingers, hold the inhaler upright,with the mouthpiece end down and pointing toward you.
    • Take the cap off the mouthpiece. Check the mouthpiece to make sureit is clear. Then, gently shake the inhaler three or four times.
    • Breathe out slowly to the end of a normal breath.
    • Use the inhalation method recommended by your doctor:
      • Open-mouth method?Place the mouthpiece about 1 to 2 inches(2 finger widths) in front of your widely opened mouth. Make sure the inhaleris aimed into your mouth so the spray does not hit the roof of your mouthor your tongue.
      • Closed-mouth method?Place the mouthpiece in your mouth betweenyour teeth and over your tongue with your lips closed tightly around it. Makesure your tongue or teeth are not blocking the opening.
    • Start to breathe in slowly through your mouth. At the same time,press the top of the canister one time to get 1 puff of medicine. Continueto breathe in slowly for 3 to 5 seconds. Count the seconds while breathingin. It is important to press the canister and breathe in slowly at the sametime so the medicine gets into your lungs. This step may be difficult at first.If you are using the closed-mouth method and you see a fine mist coming fromyour mouth or nose, the inhaler is not being used correctly.
    • Hold your breath as long as you can up to 10 seconds. This givesthe medicine time to settle into your airways and lungs.
    • Take the mouthpiece away from your mouth and breathe out slowly.
    • If your doctor has told you to inhale more than 1 puff of medicineat each dose, gently shake the inhaler again and take the next puff followingexactly the same steps you used for the first puff. Press the canister onetime for each puff of medicine.
    • When you are done, wipe off the mouthpiece and replace the cap.

Your doctor, nurse, or pharmacist may want you to use a spacer or holdingchamber with the inhaler. A spacer helps get the medicine into the lungs andreduces the amount of medicine that stays in your mouth and throat.

To use a spacer with the inhaler:

  • Attach the spacer to the inhaler according to the manufacturer'sdirections. There are different types of spacers available, but the methodof breathing is the same with most spacers.
  • Gently shake the inhaler and spacer three or four times.
  • Hold the mouthpiece of the spacer away from your mouth and breatheout slowly to the end of a normal breath.
  • Place the mouthpiece into your mouth between your teeth and overyour tongue with your lips closed around it.
  • Press down on the canister top one time to release 1 puff of medicineinto the spacer. Within one or two seconds, begin to breathe in slowly throughyour mouth for three to five seconds. Do not breathe in through your nose.Count the seconds while inhaling.
  • Hold your breath as long as you can up to ten seconds (count slowlyto ten).
  • Breathe out slowly. Do not remove the mouthpiece from your mouth.Breathe in and out slowly two or three times to make sure the spacer is emptied.
  • If your doctor has told you to take more than 1 puff of medicineat each dose, gently shake the inhaler and spacer again, and take the nextpuff, following exactly the same steps you used for the first puff. Do notput more than 1 puff of medicine into the spacer at a time.
  • If you rinse your mouth with water after you have finished, be sureto spit out the rinse water. Do not swallow it.
  • When you are finished, remove the spacer from the inhaler. Wipe offthe mouthpiece and replace the cap.
  • Clean the inhaler and mouthpiece at least once a week.
    • To clean the inhaler:
      • Remove the canister from the inhaler and set the canister aside.
      • Wash the mouthpiece and cap with warm, soapy water. Then, rinse wellwith warm, running water.
      • Shake off the excess water and let the inhaler parts air dry completelybefore putting the inhaler back together.
  • Save your inhaler. Refill units may be available.

For patients using the powder for inhalation dosageform:

  • These medicines are used with a special device. If you do not understandthe directions that come with the inhaler or if you are not sure how to usethe inhaler, ask your health care professional to show you how to use it.Also, ask your health care professional to check regularly how you use theinhaler to make sure you are using it properly.

For patients using the inhalation solution dosage form:

  • If you are using this medicine in a nebulizer, make sure you understandexactly how to use it. If you have any questions about this, check with yourhealth care professional.
  • Do not use if solution turns pinkish to brownish in color or if itbecomes cloudy.
  • Do not mix another inhalation medicine with an adrenergic bronchodilatormedicine in the nebulizer unless told to do so by your health care professional.

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

The number of inhalations or the amount of medicine that you use dependson the strength of the medicine. Also, the number ofdoses you take each day, the time allowed between doses, and the length oftime you take the medicine depend on the medical problem for which you aretaking the adrenergic bronchodilator.

    For albuterol
  • For inhalation aerosol dosage form:
    • For preventing or treating bronchospasm:
      • Adults and children 4 years of age and older?1 to 2 inhalations(puffs) every four to six hours.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    • For preventing bronchospasm caused by exercise:
      • Adults and children 4 years of age and older?2 inhalations(puffs) taken fifteen minutes before you start to exercise.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    For albuterol sulfate
  • For inhalation aerosol dosage form:
    • For treating bronchospasm:
      • Adults and children 4 years of age and older?1 to 2 inhalations(puffs) every four to six hours.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    • For preventing bronchospasm caused by exercise:
      • Adults and children 4 years of age and older?2 inhalations(puffs) taken fifteen to thirty minutes before you start to exercise.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
  • 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 five to fifteen minutes.The usual dose is 2.5 milligrams (mg) of albuterol taken every four to sixhours if needed.
      • Children up to 12 years of age?This medicine is used in a nebulizerand is taken by inhalation over five to fifteen minutes. The usual dose is1.25 to 2.5 milligrams (mg) of albuterol taken every four to six hours ifneeded.
  • For capsules (powder) for inhalationdosage form:
    • For preventing or treating bronchospasm:
      • Adults and children 4 years of age and older?200 or 400 mcgtaken by inhalation every four to six hours.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    • For preventing bronchospasm caused by exercise:
      • Adults and children 4 years of age and older?200 mcg takenby inhalation fifteen minutes before you start to exercise.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    For bitolterol

    Note:

    Bitolterol was withdrawn from the U.S. market by Elan Pharmaceuticalsin November 2001.

  • For inhalation aerosol dosage form:
    • For preventing or treating bronchospasm:
      • Adults and children 12 years of age and older?2 inhalations(puffs) every eight hours or 2 inhalations (puffs) at first, allowing oneto three minutes between each puff. This dose may be followed by another puff,if needed. However, the dose taken each day should not be more than 2 puffsevery four hours or 3 puffs every six hours.
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
    • For preventing bronchospasm caused by exercise:
      • Adults and teenagers?2 inhalations (puffs) taken five minutesbefore you start to exercise.
      • Children?1 or 2 inhalations (puffs) taken five minutes beforeyou start to exercise.
  • 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 ten to fifteen minutes.The usual dose is 1 to 2.5 milligrams (mg) of bitolterol taken three or fourtimes a day. Doses should be taken at least four hours apart.
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
    For epinephrine
  • For treating bronchospasm:
    • For inhalation aerosol dosage form:
      • Adults and children 4 years of age and older?1 inhalation (puff).The dose may be repeated after at least one minute, if needed. Doses shouldbe taken at least three hours apart.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    • For inhalation solution dosage form:
      • Adults and children 4 years of age and older?This medicineshould be used in a hand-bulb nebulizer. The usual dose is 1 to 3 inhalations(puffs) of a 1% solution. Doses should be taken at least three hours apart.
      • Children up to 4 years of age?Dose must be determined by yourdoctor.
    For fenoterol
  • For inhalation aerosol dosage form:
    • For preventing or treating bronchospasm:
      • Adults and children 12 years of age and older?100 or 200 micrograms(mcg) , repeated three or four times a day if needed. This medicine shouldnot be taken more often than every four hours. The total dose should not bemore than 8 puffs a day of the 100 mcg per spray product or 6 puffs of the200 mcg per spray product .
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
  • 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 ten to fifteen minutes.The usual dose is 0.5 to 1 milligram (mg) of fenoterol taken every six hoursif needed.
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
    For formoterol
  • For powder for inhalation dosage form:
    • For preventing bronchospasm:
      • Adults and children 5 years of age and older? 12 mcg takenby oral inhalation twice daily
      • Children under 5 years of age?Use and dose must be determinedby your doctor.
  • Note:

    Canadian product information states that formoterol is used in children6 years of age and older.

    For isoetharine
  • For inhalation solution dosage form:
    • For treating bronchospasm:
      • Adults?This medicine is used in a nebulizer and is taken byinhalation over fifteen to twenty minutes. The amount of medicine you useand whether it requires dilution depends on the product ordered by your doctor.The usual dose is 2.5 to 10 milligrams (mg). This medicine usually shouldnot be used more often than every four hours.
      • Children?Use is not recommended.
  • For inhalation aerosol dosage form:
    • For treating bronchospasm:
      • Adults and teenagers?1 or 2 inhalations (puffs). This dosemay be repeated every four hours as necessary.
      • Children?Use is not recommended.
    For isoproterenol
  • For inhalation solution dosage form:
    • For treating bronchospasm:
      • Adults and teenagers?This medicine is used in a nebulizer andis taken by inhalation over ten to twenty minutes. The usual dose is 2.5 milligrams(mg). This medicine usually should not be used more often than every fourhours.
      • Children?This medicine is used in a nebulizer and is takenby inhalation over ten to twenty minutes. The usual dose is 0.05 to 0.1 milligram(mg) per kilogram (kg) of body weight, up to 1.25 mg, diluted. The dose maybe repeated every four hours, if needed.
    For isoproterenol hydrochloride
  • For inhalation aerosol dosage form:
    • For treating bronchospasm:
      • Adults and children 12 years of age and older?1 inhalation(puff), repeated after two to five minutes if needed. This dose is taken everythree to four hours.
      • Children up to 12 years of age?Use is not recommended.
    For isoproterenol sulfate
  • For inhalation aerosol dosage form:
    • For treating bronchospasm:
      • Adults and children 12 years of age and older?1 inhalation(puff), repeated after two to five minutes if needed. This dose is taken everyfour to six hours.
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
    For metaproterenol
  • For inhalation aerosol dosage form:
    • For preventing and treating bronchospasm:
      • Adults and children 12 years of age and older?2 or 3 inhalations(puffs) every three to four hours. The total dose should not be more than12 puffs a day.
      • Children up to 12 years of age?1 to 3 inhalations (puffs) everythree to four hours. The total dose should not be more than 12 puffs a day.
  • For inhalation solution dosage form:
    • For preventing or treating bronchospasm:
      • Adults and children 6 years of age and older?This medicineis used in a nebulizer and is taken by inhalation. The amount of medicineyou use and whether it requires dilution depends on the product ordered byyour doctor. The usual dose is 10 to 15 milligrams (mg) taken three or fourtimes a day. Doses should be taken at least four hours apart.
      • Children up to 6 years of age?This medicine is used in a nebulizerand is taken by inhalation. The amount of medicine you use and whether itrequires dilution depends on the product ordered by your doctor. The usualdose is 5 to 15 milligrams (mg) taken three or four times a day, at leastfour hours apart.
    For pirbuterol
  • For inhalation aerosol dosage form:
    • For preventing and treating bronchospasm:
      • Adults and children?1 or 2 inhalations (puffs) every four tosix hours. The total dose should not be more than 12 puffs a day.
    • For preventing bronchospasm caused by exercise:
      • Adults and children?2 inhalations (puffs) taken five minutesbefore you start to exercise.
    For procaterol
  • For inhalation aerosol dosage form:
    • For preventing and treating bronchospasm:
      • Adults and children 12 years of age and older?1 or 2 inhalations(puffs) three times a day.
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
    • For preventing bronchospasm caused by exercise:
      • Adults and children 12 years of age and older?1 or 2 inhalations(puffs) taken at least fifteen minutes before you start to exercise.
    For salmeterol
  • For the inhalation aerosol dosage form:
    • For preventing bronchospasm:
      • Adults and children 12 years of age and older?2 inhalations(puffs) two times a day, in the morning and evening. Doses should be takenabout twelve hours apart.
      • Children up to 12 years of age?Dose must be determined byyour doctor.
    • Note:

      Canadian manufacturer states that use in children ages 4 years andolder is 2 inhalations twice daily.

    • For preventing bronchospasm caused by exercise:
      • Adults and children 12 years of age and older?2 inhalations(puffs) taken at least thirty to sixty minutes before you start to exercise.If you are already using salmeterol two times a day to treat your asthma,you do not need to use additional salmeterol before you exercise. If you exercisemore than once a day, you should not take more than 2 doses per day, a minimumof 12 hours apart.
      • Children up to 12 years of age?Dose must be determined by yourdoctor.
  • For the powder for inhalation dosageform:
    • For preventing bronchospasm:
      • Adults and children 4 years of age and older?1 inhalation (thecontents of one blister) two times a day, in the morning and evening. Dosesshould be taken about twelve hours apart.
      • Children up to 4 years of age?Use and dose must be determinedby your doctor.
    • For preventing bronchospasm caused by exercise:
      • Adults and children 4 years of age and older?1 inhalation (thecontents of one blister) at least 30 minutes before exercise
      • Children up to 4 years of age?Use and dose must be determinedby your doctor.
    For terbutaline
  • For inhalation aerosol dosage form:
    • For preventing or treating bronchospasm:
      • Adults and children?
        • For the 200 microgram (mcg) per metered spray product: 2 inhalations(puffs) every four to six hours.
        • For the 500 mcg per metered spray product: 1 inhalation (puff), repeatedafter five minutes if needed. The total dose should not be more than 6 puffsa day.
    • For preventing bronchospasm caused by exercise:
      • Adults and children?
        • For the 200 microgram (mcg) per metered spray product: 2 inhalations(puffs) taken five to fifteen minutes before you start to exercise.

Missed dose?

  • For formoterol: If you miss a regularlyscheduled dose of formoterol and it has been less than 6 hours since the scheduledtime, take the dose as soon as possible and then go back to your regular dosingschedule. If it has been longer than 6 hours, skip the dose and take the next dose at the regularly scheduled time. Do not double doses.
  • For all other adrenergic bronchodilators:If you are using one of these medicines regularly and you miss a dose, useit as soon as possible. Then use any remaining doses for that day at regularlyspaced intervals. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat.
  • Store the solution form of this medicine away from direct light.Store the inhalation aerosol form of this medicine away from direct sunlight.
  • Keep the medicine from freezing.
  • Store canister with the nozzle end down.
  • Do not store the powder for inhalation forms of these medicines inthe bathroom, near the kitchen sink, or in other damp places. Moisture maycause the medicine to break down.
  • Do not puncture, break, or burn the inhalation aerosol container,even if it is empty.
  • 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 using oneof these medicines, or if your condition becomes worse, check with your doctorat once.

You may also be taking an anti-inflammatory medicine for asthma along withthis medicine. Do not stop taking the anti-inflammatorymedicine even if your asthma seems better, unless you are told to do so byyour doctor.

For patients using salmeterol or formoterol, check with your doctor:

  • If you need to use 4 or more inhalations (puffs) a day of a fast-actinginhaled bronchodilator for 2 or more days in a row to relieve asthma attacks.
  • If you need to use more than 1 canister (a total of 200 inhalationsper canister) of a fast-acting inhaled bronchodilator in a 2-month periodto relieve asthma attacks.

For patients using any of these medicines except salmeteroland formoterol, check with your doctor:

  • If you need more inhalations (puffs) than usual of a fast-actingbeta-adrenergic bronchodilator to relieve an acute attack
  • If not using an anti-inflammatory medicine and using a fast-actingbeta-adrenergic bronchodilator to relieve symptoms more than two times perweek
  • If you are using an anti-inflammatory medicine and you also are usingmore than 1 canister per month of a fast-acting beta-adrenergic bronchodilatorto relieve symptoms


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 mayneed medical attention.

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

    Rare

      Dizziness, severe; feeling of choking,irritation, or swelling in throat; flushing or rednessof skin; hives; increasedshortness of breath; skin rash; swelling of face, lips, or eyelids; tightness inchest or wheezing, troubled breathing

    Incidence not known (for salmeterol)

      Difficulty breathing; noisy breathing

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

    More common

      Fast heartbeat; headache; nervousness; trembling

    Less common

      Coughing or other bronchial irritation; dizziness or light-headedness; dryness or irritationof mouth or throat

    Rare

      Chest discomfort or pain; drowsinessor weakness; irregular heartbeat; irritation of throat or mouth; muscle cramps or twitching; nausea and/or vomiting; restlessness; trouble in sleeping

Not all of the side effects listed above have been reported for each ofthese medicines, but they have been reported for at least one of them. Allof the adrenergic bronchodilators are similar, so any of the above side effectsmay occur with any of these medicines.

While you are using an adrenergic bronchodilator, you may notice an unusualor unpleasant taste. This may be expected and will go away when you stop usingthe medicine.

Isoproterenol may cause the saliva to turn pinkish to red. This is to beexpected while you are taking this medicine.

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


Additional Information

Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although these uses are not included in product labeling, some ofthe adrenergic bronchodilators are used in certain patients with the followingmedical conditions:

  • Hyperkalemia (too much potassium in the blood) in children (albuterol)


Revised: 09/19/2005