THEOPHYLLINE tablet, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Glenmark Pharmaceuticals Inc., USA

INN（国際名）:

THEOPHYLLINE ANHYDROUS

構図:

THEOPHYLLINE ANHYDROUS 400 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. Theophylline extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

製品概要:

Theophylline (Anhydrous) Extended-Release Tablets 400 mg are supplied in CRC bottles containing 100 tablets (NDC 68462-380-01) and non-CRC bottles containing 500 tablets (NDC 68462-380-05). Each white to off-white, round shaped, uncoated 400 mg tablet is debossed with ‘G70’ on either side of the break line and ‘400’ on the other side. Theophylline (Anhydrous) Extended-Release Tablets 600 mg are supplied in CRC bottles containing 100 tablets (NDC 68462-356-01) and non-CRC bottles containing 500 tablets (NDC 68462-356-05). Each white to off-white rectangular shaped, uncoated 600 mg tablet is debossed with ‘G70’ on either side of the score line and ‘600’ on the other side.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
GLENMARK PHARMACEUTICALS INC., USA
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THEOPHYLLINE (ANHYDROUS) EXTENDED RELEASE TABLETS 400 MG AND 600 MG
DESCRIPTION
Theophylline (anhydrous) Extended-Release Tablets in a
controlled-release system allows
a 24-hour dosing interval for appropriate patients.
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:
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of
180.17 g/mol.
Each extended-release tablet for oral administration contains 400 or
600 mg of
anhydrous theophylline.
Inactive Ingredients: cetostearyl alcohol, hydroxyethyl cellulose,
magnesium stearate,
povidone and talc.
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 bronchodilatation 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).
7
8
4
2
Theophylline increases the force of contraction of diaphragmatic
muscles. This action
appears to be due to enhancement of calcium uptake through an
adenosine-media