País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
AMINOPHYLLINE DIHYDRATE (UNII: C229N9DX94) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Hospira, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. Aminophylline is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product including ethylenediamine.
Aminophylline Injection, USP 25 mg/mL is supplied in single-dose containers as follows: Unit of Sale Concentration Each NDC 0409-5921-10 Carton containing 25 250 mg/10 mL (25 mg/mL) NDC 0409-5921-09 10 mL Partial-fill Single-dose Fliptop Vial Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] PROTECT FROM LIGHT. Store in carton until time of use. SINGLE-DOSE CONTAINER. Discard unused portion. Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA N+ and NOVAPLUS are registered trademarks of Vizient, Inc. LAB-1015-2.0 Revised: 11/2017
Abbreviated New Drug Application
AMINOPHYLLINE- AMINOPHYLLINE INJECTION, SOLUTION HOSPIRA, INC. ---------- AMINOPHYLLINE RX ONLY INJECTION, USP 25 MG/ML AMINOPHYLLINE, DIHYDRATE (EQUIVALENT TO 19.7 MG/ML OF ANHYDROUS THEOPHYLLINE) FLIPTOP VIAL _DESCRIPTION_ Aminophylline Injection, USP is a sterile, nonpyrogenic solution of aminophylline in water for injection. Aminophylline (dihydrate) is approximately 79% of anhydrous theophylline by weight. Aminophylline Injection is administered by slow intravenous injection or diluted and administered by intravenous infusion. The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Aminophylline is a 2:1 complex of theophylline and ethylenediamine. Theophylline is structurally classified as a methylxanthine. Aminophylline occurs as a white or slightly yellowish granule or powder, with a slight ammoniacal odor. Aminophylline has the chemical name 1H-Purine-2, 6-dione, 3,7-dihydro-1,3-dimethyl-, compound with 1,2-ethanediamine (2:1). The structural formula of aminophylline (dihydrate) is as follows: The molecular formula of aminophylline dihydrate is C H N O • 2(H O) with a molecular weight of 456.46. Aminophylline Injection, USP contains aminophylline (calculated as the dihydrate) 25 mg/mL (equivalent to 19.7 mg/mL anhydrous theophylline) prepared with the aid of ethylenediamine. The solution may contain an excess of ethylenediamine for pH adjustment. pH is 8.8 (8.6 to 9.0). The osmolar concentration is 0.17 mOsmol/mL (calc.). _CLINICAL PHARMACOLOGY_ MECHANISM OF ACTION: 16 24 10 4 2 Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., nonbronchodilator prophylactic effects). While the mechanisms of action of theophylline are not known with certainty, studies in animals suggest that bronchodilation is mediated by the inhibi Leia o documento completo