THEOPHYLLINE tablet, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Bionpharma Inc.,

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Theophylline Extended-release Tablets 300 mg: White to off-white, capsule-shaped, uncoated tablet, with break line (functional score) and debossing with ‘ TL1 ’ on one side and plain on the other side. NDC 69452-267-20 Bottle of 100 450 mg: White to off-white, capsule-shaped, uncoated tablet, with break line (functional score) and debossing with ‘ TL2 ’ on one side and plain on the other side. NDC 69452-268-20 Bottle of 100 Dispense in a well-closed container, with child-resistant closure [as defined in the USP]. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Bionpharma Inc. Princeton, NJ 08540 USA MADE IN INDIA Revised: 07/2023 FDA-03

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
BIONPHARMA INC.,
----------
THEOPHYLLINE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Theophylline is structurally classified as a methylxanthine. It occurs
as a white, odorless,
crystalline powder. It is slightly soluble in water and chloroform,
sparingly soluble in
ethanol, very slightly soluble in ether and dichloromethane.
Theophylline anhydrous, USP
has the chemical name 1 _H-_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
300 mg or 450 mg
of theophylline anhydrous, USP. Tablets also contain inactive
ingredients: hypromellose,
lactose monohydrate, 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 bronchodilation 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
7
8
4
2
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
mus