(levalbuterol tartrate) Inhalation Aerosol
The active component of XOPENEX HFA is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta2-adrenergic receptor agonist (see CLINICAL PHARMACOLOGY). Levalbuterol tartrate has the chemical name (R)-a1-[[(1,1- dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure:
The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (C13H21NO3)2• C4H6O6. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol.
Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States.XOPENEX HFA is a pressurized metered-dose aerosol inhaler (MDI), which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF.
The inhaler should be primed by releasing 4 sprays into the air, away from the face, before using it for the first time and when the inhaler has not been used for more than 3 days. After priming with 4 actuations, each actuation delivers 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator (or mouthpiece). Each 15 g canister provides 200 actuations (or inhalations) and each 8.4 g canister provides 80 actuations (or inhalations).
What are the possible side effects of levalbuterol inhalation (Xopenex, Xopenex Concentrate, Xopenex HFA)?
Stop using levalbuterol inhalation and seek emergency medical attention if you experience any of the following serious side effects:
- an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
- worsening of respiratory symptoms (shortness of breath, wheezing); or
- chest pain or irregular heartbeats.
Other, less serious side effects may be more likely to occur. Continue to use levalbuterol inhalation and talk to your doctor if you...
What are the precautions when taking levalbuterol tartrate inhalation aerosol (Xopenex HFA)?
Before taking levalbuterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (e.g., albuterol, metaproterenol, salmeterol); or to sympathomimetic drugs (e.g., epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., high blood pressure, abnormal heart rhythm, coronary insufficiency), seizures, overactive thyroid (hyperthyroidism), diabetes, kidney disease, low blood potassium level (hypokalemia).
This drug may make you dizzy. Do not drive, use machinery, or do any...
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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