quibron-t- Theophyllin, anhydrous tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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下载 产品特点 (SPC)
09-11-2006

有效成分:

theophylline, anhydrous (UNII: 0I55128JYK) (theophylline - UNII:C137DTR5RG)

可用日期:

Monarch Pharmaceuticals, Inc.

INN(国际名称):

Theophyllin, anhydrous

药物剂型:

TABLET

组成:

300 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. QUIBRON® -T ACCUDOSE® Tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

產品總結:

Quibron® -T Tablets: Bottles of 100, ivory, in the ACCUDOSE® Tablet design with “M 020” debossed on one side, containing 300 mg of anhydrous theophylline. NDC 61570-020-01 Store from 15°-25°C (59°-77°F) Rx only. Manufactured for Monarch Pharmaceuticals® , Inc., Bristol, TN 37620 Manufactured by Bristol-Myers Squibb, Princeton, NJ 08543

产品特点

                                QUIBRON-T- THEOPHYLLIN, ANHYDROUS TABLET
MONARCH PHARMACEUTICALS, INC.
----------
QUIBRON -T
(THEOPHYLLINE TABLETS USP)
ACCUDOSE TABLETS
IMMEDIATE-RELEASE BRONCHODILATOR
DES CRIPTION
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 1HPurine- 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.
Quibron -T is available as tablets intended for oral administration,
containing 300 mg of anhydrous
theophylline per tablet. Quibron -T is an oral bronchodilator in an
immediate-release formulation in the
ACCUDOSE Tablet design. With functional trisects and bisects, Quibron
-T Tablets can be
accurately divided into 100-, 150-, and 200-mg segments to provide a
variety of dosing increments, as
required.
QUIBRON -T TABLETS
One-third tablet
= 100 mg
One-half tablet
= 150 mg
Two-thirds tablet = 200 mg
One tablet
= 300 mg
INACTIVE INGREDIENTS: microcrystalline cellulose, yellow ferric oxide,
hydroxypropyl methylcellulose
2910, lactose monohydrate, magnesium stearate, colloidal silicon
dioxide, and sodium starch glycolate.
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
assoc
                                
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