THEOPHYLLINE solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Bryant Ranch Prepack

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Theophylline oral solution 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 oral solution is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Tóm tắt sản phẩm:

Theophylline Oral Solution, USP 80 mg/15 mL is an orange-flavored, clear, colorless to slightly yellow solution. Each 15 mL (one tablespoonful) contains 80 mg theophylline anhydrous. Theophylline Oral Solution, USP is available in bottles of 16 fl. oz. (473 mL) NDC 72162-2038-02 Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted from 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child resistant containers.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

THEOPHYLLINE- THEOPHYLLINE SOLUTION
BRYANT RANCH PREPACK
----------
THEOPHYLLINE ORAL SOLUTION, USP
80 MG/15 ML
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 1H-
Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the
following
structural formula:
STRUCTURE
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of
180.17.
Theophylline Oral Solution, USP is available as a solution intended
for oral administration,
containing 80 mg of theophylline anhydrous per 15 mL (one
tablespoonful). Theophylline
Oral Solution is alcohol free.
Theophylline Oral Solution also contains the following inactive
ingredients: anhydrous
citric acid, glycerin, methylparaben, orange oil, polysorbate 80,
propylene glycol, purified
water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol
solution.
Theophylline Oral Solution has pH of 4.3 to 4.7.
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
7
8
4
2
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 c