Proventil HFA

PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with an attached dose indicator, a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 0085-1132-04).

Store between 15° - 25°C (59° - 77°F). Store the inhaler with the mouthpiece down. For best results, canister should be at room temperature before use.

SHAKE WELL BEFORE USING.

The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product canisters, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations and when the dose indicator display window shows zero, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.

PROVENTIL HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Manufactured for: Merck Sharp & Dohme Corp„a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Developed and Manufactured by: 3M Health Care Limited Loughborough UK or 3M Drug Delivery Systems Northridge, CA 91324, USA. Revised: Sep 2017

You should not use this medication if you are allergic to albuterol.

To make sure you can safely use albuterol, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure, or congestive heart failure;
• a heart rhythm disorder;
• a seizure disorder such as epilepsy;
• diabetes; or
• overactive thyroid.

FDA pregnancy category C. It is not known whether albuterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether albuterol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using albuterol.

An albuterol inhaler should not be given to a child younger than 4 years old. Albuterol solution in a nebulizer should not be given to a child younger than 2 years of age.

Rinse with water if this medicine gets in your eyes.

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Proventil HFA. Please read with care.

Use this medicine 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 this medicine 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 this medicine. 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 this medicine, 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 this medicine. 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 this medicine, 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 this medicine 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 this medicine. 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 this medicine, 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 this medicine 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.

• It is used to open the airways in lung diseases where spasm may cause breathing problems.
• It is used to prevent exercise-induced breathing problems.

• Tell all of your health care providers that you take Proventil HFA. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more of this medicine or use it more often than you have been told. Deaths have happened when too much of Proventil HFA was taken. Talk with your doctor.
• Call your doctor right away if your normal dose does not work well, if your signs get worse, or if you need to use this medicine more often than normal.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you are taking digoxin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Proventil HFA.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Protect from cold.
• If the inhaler comes in a foil pouch, store in the foil pouch until ready for use.
• Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
• Throw away the puffer (inhaler) after the most number of sprays have been used, even if it feels like there is more drug in the can.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

The active component of PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic α1 [(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(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 (C13H21 NO3)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.

PROVENTIL® HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Proventil HFA components.