THEOPHYLLINE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

American Health Packaging

INN (Nome Internazionale):

THEOPHYLLINE ANHYDROUS

Composizione:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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. THEOPHYLINE ORAL SOLUTION, USP is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Dettagli prodotto:

THEOPHYLLINE ORAL SOLUTION, USP is a clear red solution with a fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. 15 mL unit dose cups: 50 cups (5 x 10) NDC 60687-258-71 RECOMMENDED STORAGE Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. DO NOT USE IF SEAL IS BROKEN.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

THEOPHYLLINE- THEOPHYLLINE SOLUTION
AMERICAN HEALTH PACKAGING
----------
THEOPHYLLINE ORAL SOLUTION, USP
RX ONLY
8425871/0219F
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, USP is available as a liquid intended for
oral
administration, containing 80 mg of theophylline anhydrous in each 15
mL
(tablespoonful).
THEOPHYLLINE ORAL SOLUTION, USP also contains the following inactive
ingredients:
citric acid, sodium saccharin, sodium benzoate, glycerin, propylene
glycol, FD&C Red
#40, natural and artificial fruity flavor and purified water.
THEOPHYLLINE ORAL
SOLUTION, USP has a pH of 4.3 – 4.7.
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).
7
8
4
2
Theophylline increases the force of contraction of diaphragmatic
muscles. This action
appears to be due