THEOPHYLLINE- theophylline anhydrous solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)

Disponible desde:

Pharmaceutical Associates, Inc.

Designación común internacional (DCI):

THEOPHYLLINE ANHYDROUS

Composición:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. Theophylline oral solution is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Resumen del producto:

Theophylline oral solution is a clear red solution with a mixed fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. Theophylline oral solution is available in the following oral dosage form: NDC 0121-4794-15 (Unit dose cups of 15 mL, 10 cups per tray). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

THEOPHYLLINE- THEOPHYLLINE ANHYDROUS SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
THEOPHYLLINE
ORAL SOLUTION
RX ONLY
DESCRIPTION
Theophylline is structurally classified as a methylxanthine. It occurs
as a white, odorless, crystalline
powder with a bitter taste. Anhydrous theophylline has the chemical
name 1H-Purine- 2,6-dione, 3,7-
dihydro-1,3 -dimethyl-, and is represented by the following structural
formula:
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of 180.17.
Theophylline oral solution is available as a liquid intended for oral
administration, containing 80 mg of
theophylline anhydrous and 20% alcohol in each 15 mL (tablespoonful).
Theophylline oral solution also contains the following inactive
ingredients: citric acid, FD&C Red No.
40, glycerin, saccharin sodium, imitation tutti frutti fruit flavor
and purified water. Theophylline oral
solution has a pH of 3.0 - 4.0.
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 uptake through an ade