THEO-24 theophylline anhydrous capsule extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Avera McKennan Hospital

INN (Internationale Bezeichnung):

THEOPHYLLINE ANHYDROUS

Zusammensetzung:

THEOPHYLLINE ANHYDROUS 300 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

THEO-24- THEOPHYLLINE ANHYDROUS CAPSULE, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
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THEO-24
(THEOPHYLLINE ANHYDROUS)
EXTENDED-RELEASE CAPSULES
RX ONLY
DESCRIPTION
THEOPHYLLINE
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.
Theo-24 is available as capsules intended for oral administration,
containing 100 mg, 200 mg, 300 mg,
or 400 mg of anhydrous theophylline per capsule, in an
extended-release formulation which allows a
24-hour dosing interval for appropriate patients.
Inactive ingredients are edible ink (which contains synthetic black
iron oxide, FD&C Blue No. 1, FD&C
Blue No. 2, FD&C Yellow No. 6, D&C Yellow No. 10, FD&C Red No. 40),
ethylcellulose, gelatin,
pharmaceutical glaze, colloidal silicon dioxide, starch, sucrose,
talc, titanium dioxide, and coloring
agents: 100 mg - includes FD&C Yellow No. 6; 200 mg - FD&C Red No. 3
and D&C Yellow No. 10;
300 mg - FD&C Blue No. 1 and FD&C Red No. 40; 400 mg - FD&C Red No. 40
and D&C Red No.
28.
Theo-24 Extended-release capsules meet Drug Release Test 6 as
published in the current USP
monograph for Theophylline Extended-release Capsules.
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
®
7
8
4
2
isozymes of phosphodiesterase (PDE III and, to a lesser extent, PDE
IV) while non-bronchodilator
prophylactic actions are probably mediated