ELIXOPHYLLIN - theophylline anhydrous liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Caraco Pharma, Inc.

INN (International Name):

THEOPHYLLINE ANHYDROUS

Composition:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

ELIXOPHYLLIN Elixir is a clear red solution with a mixed fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. ELIXOPHYLLIN Elixir is available in bottles of 473 mL                        NDC 49708-644-90 RECOMMENDED STORAGE Store at 25o C (77o F); excursions permitted to 15o - 30o C (59o - 86o F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: SUN Pharmaceutical Industries, Inc. 705 East Mulberry Street Bryan, Ohio 43506 Distributed By: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive Detroit, MI 48202 Iss.: 11/2012 7231T01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ELIXOPHYLLIN - THEOPHYLLINE ANHYDROUS LIQUID
CARACO PHARMA, INC.
----------
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 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 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 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).
Theophylline increases the force of contraction of diaphragmatic
muscles. This action appears to be
due to enhancement of calcium uptake through an adenosine-mediated
channel.
SERUM CONCENTRATION-EFFEC