Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
INDACATEROL MALEATE (UNII: 2JEC1ITX7R) (INDACATEROL - UNII:8OR09251MQ)
Novartis Pharmaceuticals Corporation
INDACATEROL MALEATE
INDACATEROL 75 ug
PRESCRIPTION DRUG
New Drug Application
ARCAPTA NEOHALER- INDACATEROL MALEATE CAPSULE NOVARTIS PHARMACEUTICALS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARCAPTA NEOHALER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARCAPTA NEOHALER. ARCAPTA™ NEOHALER™ (INDACATEROL INHALATION POWDER) INITIAL U.S. APPROVAL: 2011 WARNING: ASTHMA-RELATED DEATH _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ LONG-ACTING BETA -ADRENERGIC AGONISTS (LABA) INCREASE THE RISK OF ASTHMA-RELATED DEATH (5.1). A PLACEBO-CONTROLLED STUDY WITH ANOTHER LONG-ACTING BETA -ADRENERGIC AGONIST (SALMETEROL) SHOWED AN INCREASE IN ASTHMA-RELATED DEATHS IN PATIENTS RECEIVING SALMETEROL. (5.1) THIS FINDING OF AN INCREASED RISK OF ASTHMA-RELATED DEATH WITH SALMETEROL IS CONSIDERED A CLASS EFFECT OF LABA, INCLUDING INDACATEROL, THE ACTIVE INGREDIENT IN ARCAPTA NEOHALER. THE SAFETY AND EFFICACY OF ARCAPTA NEOHALER IN PATIENTS WITH ASTHMA HAVE NOT BEEN ESTABLISHED. ARCAPTA NEOHALER IS NOT INDICATED FOR THE TREATMENT OF ASTHMA. (4, 5.1) RECENT MAJOR CHANGES Contraindications (4) 09/2012 Warnings and Precautions, Immediate Hypersensitivity Reactions (5.4) 09/2012 INDICATIONS AND USAGE ARCAPTA NEOHALER is a long-acting beta -adrenergic agonist indicated for: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. (1.1) Important limitations: ARCAPTA NEOHALER is NOT indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2) ARCAPTA NEOHALER is NOT indicated for asthma. (1.2) DOSAGE AND ADMINISTRATION For oral inhalation only. DO NOT swallow ARCAPTA capsule. ARCAPTA capsules should ALWAYS be used with the NEOHALER inhaler ONLY. 75 mcg inhaled every day (once-daily). (2) DOSAGE FORMS AND STRENGTHS Inhalation powder hard capsules: 75 mcg. (3) CONTRAINDICATIONS All LABA are contraindicated in patients with asthma without use Preberite celoten dokument