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#Anoro laba lama trial#

See prior Warning and Precaution regarding CYP3A4 inhibitors. Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors as increased systemic exposure to vilanterol and cardiovascular adverse effects may occur.

Adverse reactions (incidence ≥1% and more common than placebo) in subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.

#Anoro laba lama trial#

In addition to the 6-month efficacy trials with ANORO, a 12-month trial evaluated the safety of umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD.

The most common adverse reactions (≥1% and more common than placebo) reported in four 6‑month clinical trials with ANORO (and placebo) were: pharyngitis, 2% (<1%) sinusitis, 1% (<1%) lower respiratory tract infection, 1% (<1%) constipation, 1% (<1%) diarrhea, 2% (1%) pain in extremity, 2% (1%) muscle spasms, 1% (<1%) neck pain, 1% (<1%) and chest pain, 1% (<1%).

Be alert to hypokalemia and hyperglycemia.

Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.

Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.

Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with narrow-angle glaucoma.

Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

ANORO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. If such effects occur, ANORO may need to be discontinued.

Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles.

Discontinue ANORO if such reactions occur.

Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of ANORO.

If paradoxical bronchospasm occurs, discontinue ANORO and institute alternative therapy.

Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur.Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA. ANORO should not be used more often or at higher doses than recommended or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result.Acute symptoms should be treated with an inhaled, short-acting beta 2-agonist. ANORO is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms.ANORO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.Available data do not suggest an increased risk of death with use of LABA in patients with COPD. These findings are considered a class effect of LABA monotherapy. Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. ANORO is not indicated for the treatment of asthma. The safety and effectiveness of ANORO in patients with asthma have not been established.use of a long-acting beta 2-adrenergic agonist (LABA), including vilanterol, one of the active ingredients in ANORO, without an inhaled corticosteroid (ICS), in patients with asthma.patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients.