XOPENEX HFA™

For Oral Inhalation Only

Before using your XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol, read the complete instructions carefully.

ABOUT XOPENEX HFA INHALATION AEROSOL

Use only as directed by a doctor. Children should use XOPENEX HFA Inhalation Aerosol under adult supervision, as instructed by the patient's doctor.

XOPENEX HFA Inhalation Aerosol is a pressurized metered-dose inhaler that produces an aerosol for oral inhalation. XOPENEX HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs).

The blue actuator (or mouthpiece) supplied with XOPENEX HFA Inhalation Aerosol should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA Inhalation Aerosol canister.

HOW TO USE YOUR XOPENEX HFA INHALATION AEROSOL

1. SHAKE THE INHALER WELL immediately before each use.
2. REMOVE THE CAP FROM THE ACTUATOR (OR MOUTHPIECE) (see Figure 1). Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use.
   
   PRIMING: Priming at specified times is important for the proper delivery of your medication. SHAKE THE INHALER WELL; then prime XOPENEX HFA Inhalation Aerosol by releasing 4 test sprays into the air, away from your face, before using for the first time and when the inhaler has not been used for more than 3 days.
3. BREATHE OUT FULLY THROUGH YOUR MOUTH, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece-down position (see Figure 2) and closing your lips around it.
4. WHILE BREATHING IN DEEPLY AND SLOWLY THROUGH YOUR MOUTH, FULLY DEPRESS THE TOP OF THE METAL CANISTER with your middle finger as shown in Figure 2. Immediately after the puff is delivered, release your finger from the canister and remove the inhaler from your mouth.
5. HOLD YOUR BREATH FOR 10 SECONDS, IF POSSIBLE.
6. If your doctor has prescribed more than a single inhalation/puff, wait 1 minute between inhalations. Then, SHAKE THE INHALER WELL and repeat steps 3 through 5.
7. REPLACE THE CAP ON THE MOUTHPIECE AFTER EACH USE.
8. CLEAN THE ACTUATOR OR MOUTHPIECE AT LEAST ONCE A WEEK. See CLEANING YOUR XOPENEX HFA INHALATION AEROSOL for cleaning instructions.
9. DISCARD THE CANISTER AFTER YOU HAVE USED EITHER 200 INHALATIONS FROM THE 15 g CANISTER OR 80 INHALATIONS FROM THE 8.4 g CANISTER. The correct amount of medicine in each inhalation cannot be assured after 200 sprays from the 15 g canister or 80 sprays from the 8.4 g canister, even though the canister is not completely empty. Never immerse the canister in water to determine how full the canister is (“float test”). Before you reach either 200 sprays or 80 sprays, you should consult your doctor to determine whether a refill is needed. Just as you should not take extra doses without consulting your doctor, you also should not stop using XOPENEX HFA Inhalation Aerosol without consulting your doctor.

CLEANING YOUR XOPENEX HFA INHALATION AEROSOL

KEEPING THE BLUE PLASTIC ACTUATOR (OR MOUTHPIECE) CLEAN IS VERY IMPORTANT TO PREVENT MEDICINE BLOCKAGE. THE ACTUATOR SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR-DRIED THOROUGHLY AT LEAST ONCE A WEEK. THE INHALER MAY STOP WORKING IF NOT PROPERLY CLEANED.

ROUTINE CLEANING INSTRUCTIONS:

Step 1. To clean the blue plastic actuator (or mouthpiece), remove the canister and red mouthpiece cap.

Step 2. Wash the actuator through the top and bottom with warm running water for 30 seconds at least once a week (see Figure 3).

Do not clean the metal canister or allow the metal canister to become wet. Never immerse the metal canister in water.

Step 3. To dry, shake off excess water and let the actuator air-dry thoroughly, such as overnight (see Figure 4).

Step 4. When the actuator is dry, replace the canister and the mouthpiece cap; make sure the canister is fully and firmly inserted into the actuator. Blockage from medicine build- up is more likely to occur if the actuator is not allowed to air-dry thoroughly.

IF YOUR ACTUATOR BECOMES BLOCKED (little or no medicine coming out of the mouthpiece, see Figure 5), wash your actuator as described in Steps 1 and 2 and air- dry thoroughly as described in Step 3.

IF YOU NEED TO USE YOUR INHALER BEFORE THE PLASTIC ACTUATOR IS COMPLETELY DRY, SHAKE EXCESS WATER off the actuator, replace the canister, shake well, and test-spray twice into the air, away from your face, to remove most of the water remaining in the actuator. Then take your dose as prescribed. After such use, rewash the actuator and air-dry it thoroughly as described in Steps 1 through 3.

ADDITIONAL INFORMATION ABOUT XOPENEX HFA INHALATION AEROSOL

DOSAGE: Use only as directed by your doctor.

WARNINGS: The action of XOPENEX HFA Inhalation Aerosol should last for 4 to 6 hours. XOPENEX HFA Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of doses of XOPENEX HFA Inhalation Aerosol without consulting your physician. If you find that treatment with XOPENEX HFA Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using XOPENEX HFA Inhalation Aerosol, other inhaled drugs and asthma medication should be taken only as directed by your physician.

Common adverse effects include palpitations, chest pain, rapid heart rate, tremor, and nervousness. If you are pregnant or nursing, contact your physician about the use of XOPENEX HFA Inhalation Aerosol. Effective and safe use of XOPENEX HFA Inhalation Aerosol includes an understanding of the way that it should be administered. In general, the technique for administering XOPENEX HFA Inhalation Aerosol to children is similar to that for adults. Children should use XOPENEX HFA Inhalation Aerosol under adult supervision, as instructed by the patient's physician.

Storage: Store canister between 20° and 25°C (68° and 77°F). Protect from freezing temperatures and direct sunlight. Store inhaler with the actuator (or mouthpiece) down. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Avoid spraying in eyes. Keep out of reach of children.

CFC-Free: XOPENEX HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs). Instead, the inhaler contains a hydrofluoroalkane (HFA-134a) as the propellant.

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