THEOPHYLLINE- theophylline anhydrous solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Marlex Pharmaceuticals 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. THEOPHYLLINE ORAL SOLUTION, USP is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Product summary:

THEOPHYLLINE ORAL SOLUTION, USP is a clear red solution with a fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. THEOPHYLLINE ORAL SOLUTION, USP is available in bottles of 473 mL             NDC 10135-0604-08             Bottles of 473mL (16 ounces)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE- THEOPHYLLINE ANHYDROUS SOLUTION
MARLEX PHARMACEUTICALS INC
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THEOPHYLLINE
THEOPHYLLINE ORAL SOLUTION, USP 80 MG/ 15 ML
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 C H N 0
with a molecular weight of 180.17.
THEOPHYLLINE ORAL SOLUTION, USP is available as a liquid intended for
oral administration,
containing 80 mg of theophylline anhydrous in each 15 mL
(tablespoonful).
THEOPHYLLINE ORAL SOLUTION, USP also contains the following inactive
ingredients: citric
acid, sodium saccharin, sodium benzoate, glycerin, propylene glycol,
FD and C Red #40, natural and
artificial fruity flavor and purified water. THEOPHYLLINE ORAL
SOLUTION, USP has a pH of 4.0
– 5.0.
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 appea