Albuterol Inhalation

The active component of PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic α1 [(tert-Butylamino)methyl]-4-hydroxy-w-xylene- α, α '-diol sulfate (2:l)(salt), a relatively selective beta2-adrenergic bronchodilator having the following chemical structure:

Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. 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 solid. It is soluble in water and slightly soluble in ethanol. PROVENTIL HFA 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), ethanol, and oleic acid.

Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to 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 four “test sprays” into the air, away from the face.

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

Paradoxical Bronchospasm

Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, PROVENTIL HFA Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

Deterioration Of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of PROVENTIL HFA Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Use Of Anti-inflammatory Agents

The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

Cardiovascular Effects

PROVENTIL HFA Inhalation Aerosol, like other beta- adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of PROVENTIL HFA Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PROVENTIL HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Do Not Exceed Recommended Dose

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

Use albuterol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using albuterol or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The albuterol inhalation solution (eg, Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

• Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.
• Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.
• Connect the nebulizer to the face mask or mouthpiece.
• Use the face mask or mouthpiece to breathe in the medicine.
• Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.

The albuterol inhalation aerosol (eg, Proair® HFA) and albuterol inhalation powder (eg, Proair® Respiclick®) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using albuterol. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.

To use the inhalation aerosol:

• The inhaler should be at room temperature before you use it.
• Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.
• To inhale albuterol, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.
• Hold your breath for about 10 seconds, then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.
• When you have finished all of your doses, rinse your mouth with water and spit the water out.
• Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.
• If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.
• After using the inhaler, wash the mouthpiece again and dry it completely.
• If the mouthpiece becomes blocked, washing it will help.

To use the inhalation powder:

• Take the inhaler from the foil pouch before you use it for the first time.
• The inhaler provides about 200 inhalations. The dose counter will change to red when there are "20" doses left. Call your doctor or pharmacist for a refill of prescription or medicine.
• Make sure the cap is closed before using albuterol. Do not open the cap unless you are going to use it.
• Hold the inhaler upright as you open the cap fully until you hear a "click". Your inhaler is now ready to use.
• To inhale albuterol, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Do not block the vent above the mouthpiece with your lips or fingers.
• Hold your breath for about 10 seconds or as long as you comfortably can.
• Remove the inhaler from your mouth and check the dose counter to make sure you received the medicine.
• Close the cap firmly over the mouthpiece after using the inhaler. Always close the cap after each use.
• If you are supposed to use more than one puff, repeat these steps for the second puff, starting with opening the cap fully.
• Keep the inhaler clean and dry at all times. Do not wash or put any part of the inhaler in water.
• If you need to clean the mouthpiece, wipe it gently with a dry cloth or tissue.

Dosing

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

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

• For inhalation aerosol dosage form (inhaler):
  • For treatment or prevention of bronchospasm:
    • Adults and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
    • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
  • For prevention of exercise-induced bronchospasm:
    • Adults and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
    • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
• For inhalation powder dosage form (inhaler):
  • For treatment or prevention of bronchospasm:
    • Adults and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
    • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
  • For prevention of exercise-induced bronchospasm:
    • Adults and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
    • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
• For inhalation solution dosage form (used with a nebulizer):
  • For prevention of bronchospasm:
    • Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
    • Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of albuterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep albuterol inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Throw away Proair® Respiclick® 13 months after opening the foil pouch, when the dose counter reaches "0", or after the expiration date, whichever comes first.

Consult your pharmacist.

How to use Albuterol Aerosol

Consult your pharmacist.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.