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:

General Injectables & Vaccines, Inc.

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: 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. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1171-1.0 Revised: 03/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOPHYLLINE- AMINOPHYLLINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
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AMINOPHYLLINE INJECTION, USP
AMINOPHYLLINE INJECTION, USP
25 MG/ML AMINOPHYLLINE, DIHYDRATE
(EQUIVALENT TO 19.7 MG/ML OF ANHYDROUS THEOPHYLLINE)
AMPUL
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:
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
by the inhibition of
two isozymes of phosphodiesterase (PDE III and, to a lesser e