STRIVERDI RESPIMAT

Olodaterol showed linear pharmacokinetics. On repeated once-daily inhalation steady-state of olodaterol plasma concentrations was achieved after 8 days, and the extent of exposure was increased up to 1.8-fold as compared to a single dose.

AbsorptionOlodaterol reaches maximum plasma concentrations generally within 10 to 20 minutes following drug inhalation. In healthy volunteers, the absolute bioavailability of olodaterol following inhalation was estimated to be approximately 30%, whereas the ab...

The STRIVERDI RESPIMAT clinical development program included three dose-ranging trials in COPD patients, four dose-ranging trials in asthma patients, and eight confirmatory trials in patients with COPD. Dose-ranging trials The first COPD dose-ranging trial was a randomized, double-blind, placebo-controlled, single-dose, 5-way cross-over trial in 36 patients. Results demonstrated dose-related improvements in forced expiratory volume in one second (FEV 1 ) compared to placebo. The difference in trough FEV 1 from placebo for the 2, 5, 10, and 20 mcg doses were 0.07L (95% CI 0.03, 0.11), 0.10L (0....

Long-acting beta 2 -adrenergic agonists, such as STRIVERDI RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STRIVERDI RESPIMAT is not indicated for the treatment of asthma [see Warnings and Precautions (5.1) ] . Most common adverse reactions (incidence ≥2% and more than placebo) are nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain and arthralgia....

Use of a LABA, including STRIVERDI RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1) ] . STRIVERDI RESPIMAT is not indicated for the treatment of asthma. Use of a LABA, including STRIVERDI RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma. ( 4 )

LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate STRIVERDI RESPIMAT in acutely deteriorating COPD patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 ) Do not exceed the recommended dosage. Excessive use of STRIVERDI RESPIMAT, or use in conjunction with other medications containing LABA can result in clinical...

7 DRUG INTERACTIONS Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3 , 7.1 ) Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 7.2 , 7.3 ) MAO inhibitors, tricyclic antidepressants, and drugs that prolong QTc interval may potentiate effect on cardiovascular system. Use with extreme cautio...