THEO-24- theophylline anhydrous capsule, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Endo Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

THEOPHYLLINE ANHYDROUS

रचना:

THEOPHYLLINE ANHYDROUS 100 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. Theo-24 is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

उत्पाद समीक्षा:

Theo-24 (theophylline anhydrous) is supplied in extended-release capsules containing 100, 200, 300 or 400 mg of anhydrous theophylline. Theo-24 100 mg capsules are orange opaque and natural, with markings Theo-24, 100 mg, AP, and 2832, supplied as: NDC Number               Size 52244-100-10               bottle of 100 Theo-24 200 mg capsules are orange opaque and clear, with markings Theo-24, 200 mg, AP, and 2842, supplied as: NDC Number               Size 52244-200-10               bottle of 100 Theo-24 300 mg capsules are Swedish orange and natural, with markings Theo-24, 300 mg, AP, and 2852, supplied as: NDC Number               Size 52244-300-10               bottle of 100 Theo-24 400 mg capsules are pink opaque and natural, with markings Theo-24, 400 mg, AP, and 2902, supplied as: NDC Number               Size 52244-400-10               bottle of 100 Store below 77° F (25° C).

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

THEO-24- THEOPHYLLINE ANHYDROUS CAPSULE, EXTENDED RELEASE
ENDO PHARMACEUTICALS, INC.
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THEO-24
(THEOPHYLLINE ANHYDROUS)
EXTENDED-RELEASE CAPSULES 100, 200, 300, & 400 MG
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 act