Inhalation solution approved for bronchospasm in children. (Product Marketplace).Sepracor announces that the U.S. Food and Drug Administration (FDA) has approved Xopenex[R] brand levalbuterol levalbuterol /lev·al·bu·ter·ol/ (lev?al-bu´ter-ol) R- albuterol; a ß-adrenergic agent used as the hydrochloride salt as a bronchodilator for the treatment and prophylaxis of reversible bronchospasm. HCI inhalation 1. the drawing of air or other substances into the lungs.inhala´tional 2. the drawing of an aerosolized drug into the lungs with the breath. 3. any drug or solution of drugs administered (as by means of nebulizers nebulizer /neb·u·liz·er/ (neb´u-li?zer) atomizer; a device for throwing a spray. solution for the treatment or prevention of bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma.neb·u·liz·er (n  b y or aerosols) by the nasal or oral respiratory route.bron·cho·spasm (br  ng in children 6 to 11 years old with reversible obstructive airway disease, such as asthma. Xopenex will be marketed for use in a nebulizer at dosage 1. Administration of a therapeutic agent in prescribed amounts. 2. Determination of the amount to be so administered. 3. The amount so administered. Results of a multicenter, randomized, double-blind, placebo-controlled pediatric study were included in the supplemental New Drug Application (sNDA) submission to the FDA in March 2001. In one of the largest pediatric asthma studies ever conducted for a beta-agonist beta-agonist n. (n = 338), the safety and efficacy of levalbuterol inhalation solution were evaluated at dosage strengths of 0.31 and 0.63 mg, and racemic An agent, such as albuterol, that stimulates beta-receptors in the autonomic nervous system. r albuterol albuterol /al·bu·ter·ol/ (al-bu´ter-ol) a ß agonist used as the base or sulfate salt as a bronchodilator. Of or relating to a chemical compound that contains equal quantities of dextrorotatory and levorotatory forms and therefore does not rotate the plane of incident polarized light. al·bu·ter·ol (  l-by inhalation solution at dosage strengths of 1.25 and 2.5 mg, compared with placebo, in patients with mild to moderate asthma. Both pediatric dosage strengths of levalbuterol were found to be safe and effective, according to lead investigator Henry Milgrom, MD. The study was published in the December 2001 issue of The Journal of Allergy and Clinical Immunology. The 0.31-mg dose is the lowest pediatric Xopenex dose approved by the FDA for the treatment or prevention of bronchospasm. This dose was found to be effective and to have an acceptable beta-mediated side effect profile. The recommended dosage for patients 6 to 11 years of age is 0.31 mg administered three times a day by nebulization nebulization /neb·u·li·za·tion/ (neb?u-li-za´shun) 1. conversion into an aerosol or spray. 2. treatment by an aerosol. . Routine dosing should not exceed 0.63 mg three times a day. Adverse events that occurred in [greater than or equal to]2% of patients receiving Xopenex inhalation solution or racemic albuterol and more frequently than patients receiving placebo included flu syndrome, tachycardia or increased heart rate, nervousness, and tremor. Circle 127 on Reader Service Card |
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