THEOPHYLLINE(ANHYDROUS) - theophylline tablet, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

PACK Pharmaceuticals, LLC

INN (mednarodno ime):

THEOPHYLLINE ANHYDROUS

Sestava:

THEOPHYLLINE ANHYDROUS 400 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Theophylline (Anhydrous) Extended-Release Tablets 400 mg are supplied as round, white, bisected, uncoated tablets, embossed with “N” “T4”, available in bottles of 100 tablets (NDC 16571-011-10). 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: Nostrum Laboratories, Inc. Kansas City, MO 64120 Distributed By: PACK Pharmaceuticals, LLC Buffalo Grove, IL 60089

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

THEOPHYLLINE(ANHYDROUS) - THEOPHYLLINE TABLET, EXTENDED RELEASE
PACK PHARMACEUTICALS, LLC
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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 400 or
600 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 adenosine-mediated