Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)
Aucta Pharmaceuticals, Inc
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Formoterol Fumarate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)]. Formoterol Fumarate Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of Formoterol Fumarate Inhalation Solution in asthma have not been established. Use of a LABA, including Formoterol Fumarate Inhalation Solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS (5.1)]. Formoterol Fumarate Inhalation Solution is not indicated for the treatment of asthma. There are limited available data with Formoterol Fumarate Inhalation Solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Beta-agonists may interfere with uterine contractility (see Clinical Considerations). In animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rat
Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL is supplied as clear, colorless sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below. Carton of 30 individually wrapped unit dose vials, NDC 73289-0060-1 Carton of 60 individually wrapped unit dose vials, NDC 73289-0060-2 Storage and Handling: Prior to dispensing to the patient : Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat. After dispensing to the patient : Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.
Abbreviated New Drug Application
FORMOTEROL FUMARATE- FORMOTEROL FUMARATE DIHYDRATE SOLUTION AUCTA PHARMACEUTICALS, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FORMOTEROL FUMARATE INHALATION SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE INHALATION SOLUTION INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Formoterol Fumarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) Important limitations of use: Formoterol Fumarate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2, 5.2) Formoterol Fumarate Inhalation Solution is not indicated to treat asthma. ( 1.2) DOSAGE AND ADMINISTRATION For oral inhalation only. One 20 mcg/2 mL vial every 12 hours ( 2) For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor ( 2) DOSAGE FORMS AND STRENGTHS Inhalation Solution (unit dose vial for nebulization); 20 mcg/2 mL solution (3) (5) CONTRAINDICATIONS Use of a LABA, including Formoterol Fumarate Inhalation Solution, without an inhaled corticosteroid is contraindicated in patients with asthma. (4) (6) WARNINGS AND PRECAUTIONS LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma- related events.(5.1) (7) Do not initiate Formoterol Fumarate Inhalation Solution in acutely deteriorating patients.(5.2) (7) Do not use for relief of acute symptoms. Concomitant short-acting beta2-agonists can be used as needed for acute relief.(5.2) (7) Do not exceed the recommended dose. Excessive use of Formoterol Fumarate Inhalation Solution or use in conjunction with other medications containing long-acting Lees het volledige document