Theophylline Extended-Release Tablets

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Bryant Ranch Prepack

INN（国际名称）:

THEOPHYLLINE ANHYDROUS

组成:

THEOPHYLLINE ANHYDROUS 200 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

Product: 63629-2792 NDC: 63629-2792-1 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-2792-2 60 TABLET, EXTENDED RELEASE in a BOTTLE

授权状态:

Abbreviated New Drug Application

产品特点

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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THEOPHYLLINE EXTENDED-RELEASE TABLETS
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:
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
100 mg, 200 mg, 300 mg or 450 mg
of anhydrous theophylline. Tablets also contain as inactive
ingredients: hypromellose, anhydrous
lactose, 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
bronchodilatation is mediated by the inhibition of
two isozymes of phosphodiesterase (PDE lll 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 lll or antagonism of adenosine
receptors. Some of the adverse effects
associated with theophylline appear to be mediated by inhibition of
PDE lll (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-mediated
channel.
SERUM CONCENT