Levalbuterol Inhalation Solution Concentrate and Pergolide

• Generic Name: levalbuterol
• Dosage Forms: inhalation solution, concentrate
• Other Brand Names: Xopenex, Xopenex Concentrate, Xopenex HFA

Levalbuterol is a short-acting bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Levalbuterol inhalation is used to treat or prevent asthma attacks in adults and children who are at least 4 years old.

Levalbuterol inhalation may also be used for purposes not listed in this medication guide.

• Generic Name: pergolide
• Dosage Forms: tablet
• Other Brand Names:

Formoterol: Used concomitantly with long-term asthma controller therapy (e.g., inhaled corticosteroids) for prevention of bronchospasm in patients with reversible obstructive airway disease (e.g., asthma).

Monotherapy with long-acting β2-adrenergic agonists (e.g., formoterol) increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in children and adolescents. Use of formoterol alone for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) is contraindicated. (See Asthma-related Death and Serious Asthma-related Events under Cautions.)

Formoterol in fixed combination with budesonide or mometasone (formoterol/budesonide, formoterol/mometasone): Treatment of asthma only in patients not responding adequately to long-term asthma controller therapy (e.g., inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist.

Once asthma control achieved and maintained, assess patient at regular intervals and step down therapy (e.g., discontinue formoterol or formoterol/budesonide) if possible without loss of asthma control, and maintain patient on long-term asthma controller therapy (e.g., inhaled corticosteroids).

Do not use formoterol/budesonide in patients with asthma adequately controlled on low or medium dosage of inhaled corticosteroids.

Formoterol alone or in fixed combination with budesonide or mometasone not indicated for relief of acute bronchospasm; do not initiate in patients with rapidly deteriorating or potentially life-threatening episodes of asthma. (See Acute Exacerbations of Asthma or COPD under Cautions.)

Formoterol, formoterol/budesonide, or formoterol in fixed combination with glycopyrrolate (formoterol/glycopyrrolate): Long-term maintenance treatment of bronchospasm or airflow obstruction associated with COPD, including chronic bronchitis and emphysema.

Do not initiate formoterol alone or in fixed combination with budesonide or glycopyrrolate in patients with substantially worsening or acutely deteriorating COPD; do not use to treat acute symptoms. (See Acute Exacerbations of Asthma or COPD under Cautions.)

Use of long-acting β2 agonists (e.g., formoterol) with or without inhaled corticosteroids for acute exacerbations of COPD not evaluated. Use a short-acting inhaled β2-adrenergic agonist intermittently (as needed) for acute symptoms of COPD.