AMINOPHYLLINE dihydrate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMINOPHYLLINE DIHYDRATE (UNII: C229N9DX94) (AMINOPHYLLINE - UNII:27Y3KJK423)

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

AMINOPHYLLINE DIHYDRATE

Composition:

AMINOPHYLLINE DIHYDRATE 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOPHYLLINE- AMINOPHYLLINE DIHYDRATE TABLET
WEST-WARD PHARMACEUTICAL CORP
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AMINOPHYLLINE TABLETS, USP
REV. 12/02RX ONLY
DESCRIPTION
Aminophylline is a 2:1 complex of theophylline and ethylenediamine.
Theophylline is structurally
classified as a methyxanthine. Aminophylline occurs as a white or
slightly yellowish granule or
powder, with a slight ammoniacal odor. Aminophylline has the chemical
name 1_H_-Purine-2,6-dione,3,7-
dihydro-1,3-dimethyl-,compound with 1,2 ethanedamine (2:1) and is
represented by the following
structural formula:
The molecular formula of aminophylline dihydrate is C
H N O •(H O) with a molecular weight of
456.46.
Aminophylline is available as tablets intended for oral
administration, containing 100 mg or 200 mg of
Aminophylline, USP (calculated as the dihydrate) per tablet
(equivalent to 79 mg or 158 mg of
theophylline anhydrous).
Inactive ingredients: Magnesium Stearate and Microcrystalline
Cellulose.
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.,
non-bronchodilator prophylactic effects). While the mechanisms of
action of theophylline are not
known with certainty, studies in animals suggest that
bronchodilatation is mediated by the inhibition of
two isozymes of phosphodiesterase (PDE III and, to a lesser extent,
PDE IV) while non-bronchodilator
prophylactic actions are probably mediated through one or more
different molecular mechanisms, that
do not involve inhibition of PDE III or antagonism of adenosine
receptors. Some of the adverse effects
associated with theophylline appear to be mediated by inhibition of
PDE III (e.g., hypotension,
tachycardia, headache, and emesis) and adenosine receptor antagonism
(e.g., alterations in cerebral
blood flow).
Theophylline increases the force of contraction of diaphragmatic
muscles. This action appears to be
due to enhancement of calcium