Asthma/COPD:

Indications for ARCAPTA NEOHALER:

Long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and/or emphysema.

Limitations of Use:

Not indicated to treat acute deteriorations of COPD or for treatment of asthma.

Adult:

For oral inhalation use only with Neohaler device; do not swallow caps. Remove cap from blister pack immediately before use. Inhale contents of one 75mcg cap daily.

Children:

Not established.

Contraindications:

Use of LABA without inhaled corticosteroid (ICS) in asthma.

Warnings/Precautions:

LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acute deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Hypokalemia. Hyperglycemia. Diabetes. Ketoacidosis. Severe hepatic impairment. Pregnancy (Cat.C). Labor & delivery. Nursing mothers.

Pharmacologic Class:

Long-acting beta-2 agonist (LABA).

Interactions:

See Contraindications. Avoid other sympathomimetics (except short-acting bronchodilators). Extreme caution with MAOIs, tricyclics, others that prolong QTc interval. Antagonized by β-blockers. K+-depleting diuretics, theophylline, aminophylline, steroids may potentiate hypokalemia.

Adverse Reactions:

Cough, oropharyngeal pain, nasopharyngitis, headache, nausea; hypersensitivity reactions (discontinue immediately and use alternative therapy).

Generic Availability:

NO

How Supplied:

Blister pack—30 + one Neohaler device