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:

Cranbury 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 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.

Product summary:

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 473 mL NDC 60621-033-01. 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 container. Manufactured for: Cranbury Pharmaceuticals, Inc. Monmouth Junction, NJ 08852 www.cranburypharmaceutical.com Mfd. by: Tris Pharma, Inc. Monmouth Junction, NJ 08852

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE- THEOPHYLLINE ANHYDROUS SOLUTION
CRANBURY PHARMACEUTICALS INC
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THEOPHYLLINE ORAL SOLUTION
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 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
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 diaphragmat