THEOPHYLLINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, 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 54838-556-80 RECOMMENDED STORAGE Store at 20° to 25°C (68° to 77°); [see USP Controlled Room Temperature]. Dispense in tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE- THEOPHYLLINE SOLUTION
LANNETT COMPANY, INC.
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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 O 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&C Red
#40, natural and artificial fruity flavor and purified water.
THEOPHYLLINE ORAL
SOLUTION, USP has a pH of 4.3 - 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 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)
7
8
4
2
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