Asthma/COPD:

Indications for UTIBRON NEOHALER:

Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema.

Limitations of Use:

Not indicated for relief of acute bronchospasm or for treatment of asthma.

Adult:

For oral inhalation use only with Neohaler device; do not swallow caps. Administer at the same time of the day (AM + PM). Inhale contents of one capsule (27.5mcg/15.6mcg) twice 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 or potentially life-threatening episodes of 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 immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Severe milk protein hypersensitivity. Cardiovascular disorders (eg, coronary insufficiency, cardiac arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Hypokalemia. Hyperglycemia. Severe renal impairment or ESRD requiring dialysis. Severe hepatic impairment: not studied. Pregnancy (Cat.C). Labor & delivery. Nursing mothers: not recommended.

Pharmacologic Class:

Long-acting beta2-agonist (LABA) + anticholinergic.

Interactions:

Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Concomitant xanthine derivatives, steroids, or diuretics may potentiate hypokalemia. Caution with non-K+-sparing diuretics. Extreme caution with MAOIs, tricyclics, or others that prolong QTc interval. Antagonized by β-blockers; if needed, use cardioselective agents if no acceptable alternatives. Additive effects with concomitant other anticholinergic-containing drugs; avoid.

Adverse Reactions:

Nasopharyngitis, hypertension, back pain, oropharyngeal pain; paradoxical bronchospasm, hypersensitivity reactions.

Generic Availability:

NO

How Supplied:

Blister pack—6, 60 (w. one Neohaler device)