XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.

Adult and Pediatric Asthma: For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol for adults and children 4 years of age and older is 2 inhalations (90 mcg) repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not routinely recommended. 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 3 days by releasing 4 test sprays into the air, away from the face.

If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti- inflammatory treatment, e.g., corticosteroids.

Cleaning: To maintain proper use of this product, it is critical that the actuator be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly. See Information for Patients. Keeping the plastic actuator clean is very important to prevent medication build-up and blockage. If the actuator becomes blocked with drug, washing the actuator will remove the blockage.

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is supplied as a pressurized aluminum canister in a box (NDC 63402-510-01 or NDC 63402-510-04). The canister is labeled with a net weight of 15 g or 8.4 g and contains 200 metered actuations or 80 metered actuations (or inhalations), respectively. Each canister is supplied with a blue plastic actuator (or mouthpiece), a red mouthpiece cap, and patient's instructions.

SHAKE WELL BEFORE USING. Store between 20° and 25°C (68° and 77°F; see USP controlled room temperature). Protect from freezing temperatures and direct sunlight. Store inhaler with the actuator (or mouthpiece) down. 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.

The blue actuator 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. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister or 80 actuations from the 8.4 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister or 80 actuations have been used from the 8.4 g canister.

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

Manufactured for: Sepracor Inc. Marlborough, MA 01752, USA, by 3M Drug Delivery Systems, Northridge, CA 91324-3213. For customer service, call 1-888-394-7377. To report adverse events, call 1-877-737-7226. For medical information, call 1-800-739-0565. August 2006. FDA rev date: 2/5/2008

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