THEOPHYLLINE tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Glenmark Pharmaceuticals Inc., USA

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Theophylline Extended-release Tablets: 300 mg: White to off-white, capsule shaped, uncoated tablet, debossed with “G7” and “21” separated with a score line on one side and plain on the other side. 450 mg: White to off-white, capsule shaped, uncoated tablet, debossed with “G7” and “22” separated with a score line on one side and plain on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, with child resistant closure [as defined in the USP]. Manufactured by: Glenmark Pharmaceuticals Limited Plot No. S-7, Colvale Industrial Estate Colvale - Bardez, Goa 403 513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com September 2019

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
GLENMARK PHARMACEUTICALS INC., USA
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THEOPHYLLINE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION:
Theophylline is structurally classified as a methylxanthine. It occurs
as a white, practically
odorless, crystalline powder. Theophylline Anhydrous, USP has the
chemical name 1,3-
dimethyl-3,7-dihydro-1_H_-purine-2,6-dione, and is represented by the
following structural
formula:
C H N O M.W. 180.17 g/mol.
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 as inactive
ingredients: anhydrous
lactose, 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
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
7
8
4
2
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 throug