AMINOPHYLLINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMINOPHYLLINE DIHYDRATE (UNII: C229N9DX94) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)

Available from:

Medical Purchasing Solutions, LLC

INN (International Name):

AMINOPHYLLINE DIHYDRATE

Composition:

AMINOPHYLLINE DIHYDRATE 25 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Aminophylline Injection, USP 25 mg/mL is supplied in single-dose containers as follows: NDC No. Container Volume Total Content 0409-7385-01 Ampul 10 mL 250 mg 0409-7386-01 Ampul 20 mL 500 mg 0409-5921-01 Partial-fill Fliptop Vial 10 mL 250 mg 0409-5922-01 Partial-fill Fliptop Vial 20 mL 500 mg     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.   Revised: November, 2009       Printed in USA                                                           EN-2301                                                 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOPHYLLINE- AMINOPHYLLINE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
AMINOPHYLLINE
INJECTION, USP
25 MG/ML AMINOPHYLLINE, DIHYDRATE
(EQUIVALENT TO 19.7 MG/ML OF ANHYDROUS THEOPHYLLINE)
AMPUL
FLIPTOP VIAL Rx only
_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:
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