THEOPHYLLINE (ANHYDROUS)- theophylline tablet, extended release

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:

State of Florida DOH Central Pharmacy

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 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 is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

產品總結:

Theophylline (Anhydrous) Extended-Release Tablets 200 mg are supplied as elliptical, white, bisected, uncoated tablets, embossed with “PLIVA 482”. Theophylline (Anhydrous) Extended-Release Tablets 300 mg are supplied as capsule, white, bisected, uncoated tablets, embossed with “PLIVA 459”. They are supplied by State of Florida DOH Central Pharmacy as follows: Store  at  25°C  (77°F);  excursions  permitted  between  15°-30°C  (59°-86°F).  (See  USP  Controlled Room Temperature) Dispense in tight, light-resistant container as defined in the USP. Manufactured by: PLIVA Inc. Pomona, NY 10970 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

授权状态:

Abbreviated New Drug Application

产品特点

THEOPHYLLINE (ANHYDROUS)- THEOPHYLLINE TABLET, EXTENDED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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THEOPHYLLINE (ANHYDROUS) EXTENDED-RELEASE TABLETS
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 200 or
300 mg of anhydrous
theophylline per tablet.
Inactive ingredients: glyceryl behenate, silicified microcrystalline
cellulose, silicon dioxide, and
magnesium stearate.
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 adenosi