THEOPHYLLINE tablet, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Sun Pharmaceutical Industries Limited

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

Theophylline Extended-Release Tablets: 300 mg: White to off-white, capsule shaped, uncoated functionally scored tablet debossed with a score line on one side and score line on other side. Tablet shall be free from physical defects. NDC 70095-017-01                            Bottle of 100 450 mg: White to off-white, capsule shaped, uncoated functionally scored tablet debossed with "3" and "7" separated with a score line on one side and score line on other side. Tablet shall be free from physical defects. NDC 70095-018-01                            Bottle of 100   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: Harman Finochem Limited A-100/1 Finished Dosage Form (FDF), M.I.D.C. Industrial Area, Shendra, Aurangabad, Maharashtra – 431007 INDIA   Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512   Revised: 11/2023

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

THEOPHYLLINE - THEOPHYLLINE TABLET, EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES LIMITED
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THEOPHYLLINE EXTENDED-RELEASE TABLETS
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:
C7H8N4O2 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, povidone and colloidal
silicone dioxide.
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
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