Albuterol Sulfate Inhalation Aerosol (Proair HFA)
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Albuterol Sulfate Inhalation Aerosol (Proair HFA)

PROAIR HFA
(albuterol sulfate) Inhalation Aerosol

DRUG DESCRIPTION

The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α1-[(tertbutylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure:

PROAIR HFA (albuterol sulfate) Structural Formula Illustration

The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol.

Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations).

This product does not contain chlorofluorocarbons (CFCs) as the propellant.

What are the possible side effects of albuterol inhalation (Accuneb, ProAir HFA, Proventil, Proventil HFA, Ventolin HFA)?

Stop using this medication and 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.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • tremor, nervousness;
  • low potassium (confusion, uneven...

Read All Potential Side Effects and See Pictures of Proair HFA »

What are the precautions when taking albuterol sulfate inhalation aerosol (Proair HFA)?

Before using albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (such as metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, angina, heart attack), high blood pressure, seizure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your...

Read All Potential Precautions of Proair HFA »

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

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INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

DOSAGE AND ADMINISTRATION

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

Administration Information

Administer PROAIR HFA (albuterol sulfate inhalation aerosol) by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.

Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.

Cleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried. To clean: Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms & Strengths

PROAIR HFA (albuterol sulfate inhalation aerosol) is an inhalation aerosol. PROAIR HFA (albuterol sulfate inhalation aerosol) is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Storage & Handling

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

See FDA-Approved Patient Labeling for priming and cleaning instructions.

The red actuator supplied with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is (“float test”).

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mktd by: Teva Respiratory, LLC. Horsham, PA 19044. Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland. Rev. 07/10

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.

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