"The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing "...
XOPENEX HFA 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.
DOSAGE AND ADMINISTRATION
The recommended dosage of XOPENEX HFA for adults and children 4 years of age and older is 2 inhalations (90 mcg of levalbuterol free base) repeated every 4 to 6 hours; in some patients, 1 inhalation (45 mg of levalbuterol free base) every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not routinely recommended.
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.
For oral inhalation only
- Shake well before use.
- Avoid spraying in the eyes.
- Prime the inhaler before using for the first time and when the inhaler has not been used for more than 3 days by releasing 4 test sprays into the air, away from the face.
- To maintain proper use of Xopenex HFA, it is critical to wash the actuator with warm water and air-dry thoroughly at least once a week. The inhaler may cease to deliver levalbuterol tartrate if not properly cleaned and dried thoroughly. Keep the plastic actuator clean to prevent medication build-up and blockage. If the actuator becomes blocked with levalbuterol tatrate, wash the actuator to remove the blockage.
- Discard after 200 actuations have been released from the 15 gram canister or 80 actuations have been released from the 8.4 gram canister.
Dosage Forms And Strengths
Inhalation aerosol: XOPENEX HFA is a pressurized, metered dose aerosol.
- 15 gram canister contains 200 metered actuations (or inhalations)
- 8.4 gram canister contains 80 metered actuations (or inhalations)
Each canister is supplied with a blue plastic actuator mouthpiece and a red mouthpiece cap. After priming, each actuation of the inhaler delivers 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece.
Storage And Handling
XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box:
NDC 63402-510-01: Canister labeled with a net weight of
15 grams containing 200 metered actuations (or inhalations)
NDC 63402-510-04: Canister labeled with a net weight of 8.4 grams containing 80 metered actuations (or inhalations)
Each canister is supplied with a blue plastic actuator 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 mouthpiece down.
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 should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA 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.
Manufactured for : Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA. Revised: March 2015
Last reviewed on RxList: 3/26/2015
This monograph has been modified to include the generic and brand name in many instances.
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