THEOPHYLLINE tablet, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Carilion Materials Management

INN (Algemene Internationale Benaming):

THEOPHYLLINE ANHYDROUS

Samenstelling:

THEOPHYLLINE ANHYDROUS 300 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Theophylline extended-release tablets are 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 extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Product samenvatting:

Product: 68151-1393 NDC: 68151-1393-1 1 TABLET, EXTENDED RELEASE in a BLISTER PACK

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

THEOPHYLLINE - THEOPHYLLINE TABLET, EXTENDED RELEASE
CARILION MATERIALS MANAGEMENT
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THEOPHYLLINE EXTENDED-RELEASE TABLETS
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 1_H-_Purine -2, 6-dione, 3,7-
dihydro-1, 3-dimethyl-, and is represented by the following structural
formula:
C H N O M.W. 180.17.
This product allows a 12-hour dosing interval for a majority of
patients and a 24-hour dosing interval
for selected patients (see DOSAGE AND ADMINISTRATION section for
description of appropriate
patient populations).
Each extended-release tablet for oral administration contains either
300 mg or 450 mg of anhydrous
theophylline. Tablets also contain as inactive ingredients:
hypromellose, lactose monohydrate,
magnesium stearate and povidone.
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 bronchodilation
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 to enhancement of calcium uptake through an adenosine-mediated
ch