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Xopenex HFA (Levalbuterol Tartrate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should be used with caution with XOPENEX HFA Inhalation Aerosol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

  1. Beta-blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-adrenergic agonists, such as XOPENEX HFA Inhalation Aerosol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.
  2. Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop and thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.
  3. Digoxin: Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving XOPENEX HFA Inhalation Aerosol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and XOPENEX HFA Inhalation Aerosol.
  4. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: XOPENEX HFA Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.

OVERDOSAGE

The expected symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with the abuse of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol. Treatment consists of discontinuation of XOPENEX HFA Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of XOPENEX HFA Inhalation Aerosol.

Following intravenous administration in mice, the median lethal levalbuterol HCl dose was approximately 66 mg/kg (approximately 500 times the maximum recommended daily inhalation dose of levalbuterol tartrate for adults on a mg/m2 basis and approximately 230 times the maximum recommended daily inhalation dose of levalbuterol tartrate for pediatric patients on a mg/m2 basis). Following intravenous administration in rats, the median lethal levalbuterol HCl dose was approximately 60 mg/kg (approximately 900 times the maximum recommended daily inhalation dose of levalbuterol tartrate for adults on a mg/m2 basis and approximately 430 times the maximum recommended daily inhalation dose of levalbuterol tartrate for children on a mg/m2 basis). The inhalation median lethal dose has not been determined in animals. In dogs, inhaled doses of levalbuterol HCl up to 2.73 mg/kg (approximately 140 times the maximum recommended daily inhalation dose of levalbuterol tartrate for adults on a mg/m2 basis and approximately 65 times the maximum recommended daily inhalation dose of levalbuterol tartrate for children on a mg/m2 basis) were tolerated without animal deaths.

CONTRAINDICATIONS

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of XOPENEX HFA Inhalation Aerosol.

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