• Asthma/COPD

Asthma/COPD:

Indications for STIOLTO RESPIMAT:

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

Limitations of Use:

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

Adult:

Take at same time each day. 2 inhalations once daily; max 2 inhalations/24hrs.

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 hypersensitivity reactions occur; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension). Convulsive disorders. Thyrotoxicosis. Prolongation of the QT interval. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Narrow-angle glaucoma. Monitor for signs/symptoms of prostatic hyperplasia, GI or GU obstruction. Risk of hypokalemia or hyperglycemia. Moderate to severe renal impairment: monitor for anticholinergic effects. Severe hepatic impairment. Pregnancy. Labor & delivery. Nursing mothers.

Pharmacologic Class:

Anticholinergic + long-acting beta-2 agonist (LABA).

Interactions:

Avoid with other anticholinergics. Caution with concomitant other adrenergic drugs. Concomitant xanthine derivatives, steroids, diuretics may potentiate hypokalemia. Extreme caution with MAOIs, tricyclics, or drugs known to prolong QTc interval. Antagonized by β-blockers; if needed, consider cardioselective agents. Potentiated by strong CYP450 and P-gp inhibitors (eg, ketoconazole).

Adverse Reactions:

Nasopharyngitis, cough, back pain; paradoxical bronchospasm, urinary retention, hypokalemia, hypersensitivity reactions.

Generic Availability:

NO

How Supplied:

Inhaler (w. cartridge)—4g (60 inh)