"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 hydrochloride) Inhalation Solution
XOPENEX Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see CLINICAL PHARMACOLOGY]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:
The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3•HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water.
Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States.
XOPENEX Inhalation Solution is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).
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 (Xopenex)?
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: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.
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