ELIXOPHYLLIN- theophylline anhydrous liquid

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Nostrum Laboratories, Inc.

INN (Nama Internasional):

THEOPHYLLINE ANHYDROUS

Komposisi:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Ringkasan produk:

ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) is a clear red solution with a mixed fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) is available in bottles of 473 mL                        NDC 70408-644-34 RECOMMENDED STORAGE Store at 25o C (77o F); excursions permitted to 15o - 30o C (59o - 86o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Avoid exposure to excessive heat. Manufactured by: Nostrum Laboratories, Inc. Bryan, Ohio 43506 Iss.: 07/2016 7231T04

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ELIXOPHYLLIN- THEOPHYLLINE ANHYDROUS LIQUID
NOSTRUM LABORATORIES, INC.
----------
ELIXOPHYLLIN ELIXIR
(THEOPHYLLINE ORAL SOLUTION, USP)
(BRAND OF THEOPHYLLINE ANHYDROUS)
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:
The molecular formula of anhydrous theophylline is C7H8N4O2 with a
molecular weight of 180.17.
ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) is available as
a liquid intended for oral
administration, containing 80 mg of theophylline anhydrous and 20%
alcohol in each 15 mL
(tablespoonful).
ELIXOPHYLLIN Elixir (Theophylline Oral Solution, USP) also contains
the following inactive
ingredients: anhydrous citric acid, glycerin, saccharin sodium,
artificial tutti fruiti flavor #051880A,
FD&C red #40 and purified water. ELIXOPHYLLIN Elixir (Theophylline
Oral Solution, USP) has a
pH of 3.0-4.0.
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).
Theoph