Description
Indications and Usage for Akzaventa® Maintenance Treatment of COPD Akzaventa® (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Akzaventa® Inhalation Solution is for use by nebulization only. Important Limitations of Use Akzaventa® Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)]. Akzaventa® Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of Akzaventa® Inhalation Solution in asthma have not been established. Akzaventa® Dosage and Administration The recommended dose of Akzaventa® (arformoterol tartrate) Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended. Akzaventa® Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. Akzaventa® Inhalation Solution should not be swallowed. Akzaventa® Inhalation Solution should be stored refrigerated in foil pouches. After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away. Slideshow COPD: Could You Be At Risk? If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be reevaluated and additional therapeutic options should be considered. No dose adjustment is required for patients with renal or hepatic impairment. However, since the clearance of Akzaventa® Inhalation Solution is prolonged in patients with hepatic impairment, they should be monitored closely. The drug compatibility (physical and chemical), efficacy, and safety of Akzaventa® Inhalation Solution when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of Akzaventa® Inhalation Solution have been established in clinical trials when administered using the nebulizer (with a face mask or mouthpiece) and the PARI DURA NEB™ 3000 compressor. The safety and efficacy of Akzaventa® Inhalation Solution delivered from non-compressor based nebulizer systems have not been established. Dosage Forms and Strengths Akzaventa® (arformoterol tartrate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each 2 mL vial contains 15 mcg of arformoterol equivalent to 22 mcg of arformoterol tartrate.
