"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 "...
(levalbuterol tartrate) Inhalation Aerosol
The active component of XOPENEX HFA inhalation aerosol 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)-α1[[(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 inhalation aerosol 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.
After priming with 4 actuations, each actuation of the inhaler delivers 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator 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)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
- chest pain and fast, pounding, or uneven heart beats;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp...
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 drugs (such as albuterol, metaproterenol, salmeterol); 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: diabetes, heart problems (such as irregular heartbeat, angina, previous heart attack), high blood pressure, kidney disease, seizure, overactive thyroid (hyperthyroidism).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic...
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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