Proventil HFA

Proventil is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Proventil HFA is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. It is also used to prevent exercise-induced bronchospasm.

Proventil is for use in adults and children who are at least 4 years old.

It is important to keep Proventil on hand at all times. Get your prescription refilled before you run out of medicine completely. Keep using all of your other medications as prescribed by your doctor.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. An increased need for Proventil could be an early sign of a serious asthma attack.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of albuterol can be fatal. Extreme heat can cause the Proventil HFA canister to burst. Do not store your inhaler in your car on hot days. Do not throw an empty canister into open flame.

You should not use Proventil if you are allergic to albuterol.

Excessive use of albuterol can be fatal. Do not use more of this medicine than recommended.

To make sure Proventil is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, congestive heart failure;
• a heart rhythm disorder;
• a seizure disorder such as epilepsy;
• diabetes;
• overactive thyroid; or
• low levels of potassium in your blood.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether albuterol will harm an unborn baby. However, having uncontrolled asthma during pregnancy may increase the risk of premature birth, low birth weight, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing bronchospasm may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of albuterol on the baby.

It may not be safe to breastfeed while using Proventil. Ask your doctor about any risk.

Proventil is not approved for use by anyone younger than 4 years old.

Get emergency medical help if you have signs of an allergic reaction to Proventil: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• chest pain, fast heart rate, pounding heartbeats or fluttering in your chest;
• pain or burning when you urinate;
• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common Proventil side effects may include:

• chest pain, fast or pounding heartbeats;
• upset stomach, vomiting;
• painful urination;
• dizziness;
• feeling shaky or nervous;
• headache, back pain, body aches; or
• cough, sore throat, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use Proventil exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not allow a young child to use Proventil without help from an adult.

The usual dose of Proventil is 2 inhalations every 4 to 6 hours. To prevent exercise-induced bronchospasm, use 2 inhalations 15 to 30 minutes before you exercise. The effects of Proventil should last about 4 to 6 hours.

When using the Proventil inhaler device for the first time, prime it by spraying 3 test sprays into the air, away from your face. Shake well before priming. Also prime the inhaler if you have not used it for more than 2 weeks.

The instructions below are for standard use of the inhaler. Your doctor may want you to use your device differently. Use only the inhaler device provided with your medicine or you may not get the correct dose.

To use the Proventil inhaler:

• Shake the canister well just before each spray.
• Uncap the mouthpiece of the Proventil inhaler. Breathe out fully. Put the mouthpiece into your mouth and close your lips. Breathe in slowly while pushing down on the canister. Hold your breath for 10 seconds, then breathe out slowly.
• If you use more than one inhalation at a time, wait at least 1 minute before using the second inhalation and shake the inhaler again.
• Keep your Proventil inhaler clean and dry, and store it with the cap on the mouthpiece. Clean your inhaler once a week by removing the canister and placing the mouthpiece under warm running water for at least 30 seconds. Shake out the excess water and allow the parts to air dry completely before putting the inhaler back together.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Follow all product instructions on how to clean your inhaler device and mouthpiece.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store Proventil HFA at room temperature away from moisture, heat, or cold temperatures.

Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Throw away the Proventil inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of albuterol can be fatal.

Overdose symptoms may include dry mouth, tremors, chest pain, fast heartbeats, nausea, general ill feeling, seizure (convulsions), feeling light-headed or fainting.

Rinse with water if this medicine gets in your eyes.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other inhaled medicines or bronchodilators;
• digoxin;
• a diuretic or "water pill";
• an antidepressant - amitriptyline, desipramine, imipramine, doxepin, nortriptyline, and others;
• a beta blocker - atenolol, carvedilol, labetalol, metoprolol, propranolol, sotalol, and others; or
• an MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete. Other drugs may interact with albuterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.