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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
For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage of XOPENEX HFA 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.
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
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.
To maintain proper use of this product, it is critical that the actuator be washed with warm water and air-dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly. 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.
Dosage Forms And Strengths
XOPENEX HFA 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. After priming, each actuation of the inhaler delivers 67.8 mcg levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouth piece.
Storage And Handling
XOPENEX HFA 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 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: July 2012
Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.
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