THEOPHYLLINE ANHYDROUS- theophylline tablet, extended release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Carilion Materials Management

INN:

THEOPHYLLINE ANHYDROUS

composition:

THEOPHYLLINE ANHYDROUS 400 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 (Anhydrous) Extended-Release Tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

leaflet_short:

Product: 68151-0667 NDC: 68151-0667-0 1 TABLET, EXTENDED RELEASE in a PACKAGE

authorization_status:

Abbreviated New Drug Application

SPC

THEOPHYLLINE ANHYDROUS- THEOPHYLLINE TABLET, EXTENDED RELEASE
CARILION MATERIALS MANAGEMENT
----------
THEOPHYLLINE (ANHYDROUS) EXTENDED-RELEASE TABLETS
400 MG AND 600 MG
RX ONLY
DESCRIPTION
Theophylline (Anhydrous) Extended-Release Tablets in a
controlled-release system allows a 24-hour
dosing interval for appropriate patients.
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.
Each extended-release tablet for oral administration contains 400 or
600 mg of anhydrous theophylline.
Inactive Ingredients: cetostearyl alcohol, hydroxyethyl cellulose,
magnesium stearate, povidone and
talc.
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 adenosine-mediate