ELIXOPHYLLIN- theophylline anhydrous liquid

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Carilion Materials Management

INN (Међународно име):

THEOPHYLLINE ANHYDROUS

Састав:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Резиме производа:

Product: 68151-0644 NDC: 68151-0644-1 20 mL in a SYRINGE, PLASTIC

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ELIXOPHYLLIN- THEOPHYLLINE ANHYDROUS LIQUID
CARILION MATERIALS MANAGEMENT
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ELIXOPHYLLIN ELIXIR
(THEOPHYLLINE ORAL SOLUTION, USP)
(BRAND OF THEOPHYLLINE ANHYDROUS)
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 C7H8N4O2 with a
molecular weight of 180.17.
ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) is available as
a liquid intended for oral
administration, containing 80 mg of theophylline anhydrous and 20%
alcohol in each 15 mL
(tablespoonful).
ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) also contains
the following inactive
ingredients: anhydrous citric acid, glycerin, saccharin sodium,
artificial tutti fruiti flavor #051880A,
FD&C red #40 and purified water. ELIXOPHYLLIN Elixir (Theophylline
Oral Solution, USP) 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).
The