THEOPHYLLINE tablet, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Alembic Pharmaceuticals Limited

INN (International Nazwa):

THEOPHYLLINE ANHYDROUS

Skład:

THEOPHYLLINE ANHYDROUS 300 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Theophylline Extended-release Tablets: 300 mg: White to off-white, Capsule shaped, uncoated tablet, with break line and debossing with 'HP62” on one side and plain on other side.     46708-025-30 Bottle of 30  46708-025-31 Bottle of 100  46708-025-71 Bottle of 500  46708-025-91 Bottle of 1000    450 mg: White to off-white, Capsule shaped, uncoated tablet, with break line and debossing with 'HP63” on one side and plain on other side.    46708-026-30 Bottle of 30  46708-026-31 Bottle of 100  46708-026-71 Bottle of 500    Dispense in a well-closed container, with child resistant closure [as defined in the USP]. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] Manufactured by: Alembic Pharmaceuticals Limited, (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India.   Made in India Revised: 02/2014

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

THEOPHYLLINE - THEOPHYLLINE TABLET, EXTENDED RELEASE
ALEMBIC PHARMACEUTICALS LIMITED
----------
THEOPHYLLINE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
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
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 anhydrous theophylline. Tablets also contain as 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
7
8
4
2
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
cha