Xopenex Brand of Levalbuterol

#1 prescribed short-acting beta-agonist among specialists1...

WHY CHOOSE XOPENEX FOR MY PATIENTS?
XOPENEX brand of levalbuterol provides proven efficacy and safety in adult and pediatric patients suffering from asthma and chronic obstructive pulmonary disease (COPD).

How is it different?

XOPENEX contains only the therapeutically active single (R)-isomer.

Racemic albuterol is a 50:50 mix of both the (S)- isomer and the (R)-isomer.2 XOPENEX contains only the single (R)-isomer. The (R)-isomer is known to be the isomer responsible for the bronchodilation provided by racemic albuterol.

XOPENEX Inhalation Solution (nebulizer) and XOPENEX HFA (inhaler/puffer) have demonstrated proven efficacy and safety, as seen in several pivotal clinical trials,1-3 and contains only the therapeutically active single (R)-isomer.

What is the preclinical impact of the active (R)-isomer: XOPENEX?

  • Potent binding to the beta2-receptor2,3
  • Produces all of the bronchodilation4
  • Enhances the effects of steroids5
  • Has no effect on or reduces inflammatory stimuli5,6

The clinical significance of these preclinical findings is not known.

XOPENEX - THE ONLY SHORT-ACTING BETA-AGONIST WITH ONLY THE (R)-ISOMER

XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol 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.

Click here for XOPENEX HFA Important Safety Information.

XOPENEX® (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Click here for XOPENEX Inhalation Solution Important Safety Information.

References:
1. IMS National Prescription Audit Plus, MAT, May 2006-April 2007 (includes pulmonoligists and pediatricians).
2. Page CP, Morley J. Contrasting properties of albuterol stereoisomers. J Clin Immunol. 1999;104(2, pt 2):S31-S41.
3. Mitra S, Ugur M, Ugur O, et al. (S)-albuterol increases intracellular free calcium by muscarinic receptor activation and a phospholipase C-dependent mechanism in airway smooth muscle. Mol Pharmacol. 1998;53(3):347-354.
4. Penn RB, Frielle T, McCullough JR, et al. Comparison of R-, S-, and RS-albuterol interaction with human β1- and β2-adrenergic receptors. Clin Rev Allergy Immunol. 1996;14(1):37-45.
5. Lötvall J, Palmqvist M, Arvidsson P, et al. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001;108(5):726-731.
6. Ameredes BT, Calhoun WJ. Modulation of GM-CSF release by enantiomers of beta-agonists in human airway smooth muscle. J Allergy Clin Immunol. 2005;116(1):65-72.
7. Agrawal DK, Ariyarathna K, Kelbe PW. (S)-albuterol activates pro-constrictory and pro-inflammatory pathways in human bronchial smooth muscle cells. J Allergy Clin Immunol. 2004;113(3):503-510.

Why should I specify XOPENEX HFA

Click here for patient prescribing information
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Important Safety Information

Patients receiving the highest dose of XOPENEX® (levalbuterol HCl) Inhalation Solution should be monitored closely for adverse effects, and the risk of such effects should be balanced against the potential for improved efficacy.

XOPENEX Inhalation Solution and XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol are contraindicated in patients with a history of hypersensitivity to levalbuterol hydrochloride or levalbuterol tartrate, respectively, racemic albuterol, or any component of the drug product. XOPENEX® brand of levalbuterol and other β-agonists can cause paradoxical bronchospasm, which may be life threatening: see the accompanying prescribing information regarding potential drug interaction with β-blockers, diuretics, digoxin, or MAOI and tricyclic antidepressants. If additional adrenergic drugs, including other short-acting sympathomimetic bronchodilators or epinephrine, are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Due to the cardiovascular side effects associated with β-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), diabetes, hyperthyroidism, or convulsive disorders.

XOPENEX Inhalation Solution

In patients aged 6 to 11 years, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX Inhalation Solution at either 0.31 mg or 0.63 mg and more frequently than patients receiving placebo) were headache, rhinitis, pharyngitis, asthma, fever, viral infection, rash, accidental injury, diarrhea, asthenia, lymphadenopathy, and urticaria.

In patients 12 years and older, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX Inhalation Solution at either 0.63 mg or 1.25 mg and more frequently than patients receiving placebo) were viral infection, rhinitis, nervousness, tremor, flu syndrome, sinusitis, accidental injury, anxiety, cough increased, pain, tachycardia, turbinate edema, migraine, dizziness, dyspepsia, and leg cramps.

XOPENEX HFA Inhalation Aerosol

In patients aged 4 to 11 years, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX HFA at 90 mcg and more frequently than patients receiving placebo) were vomiting, accidental injury, pharyngitis, and bronchitis.

In patients 12 years and older, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX HFA at 90 mcg and more frequently than patients receiving placebo) were asthma, pharyngitis, rhinitis, pain, and dizziness.