UNIPHYL- theophylline anhydrous tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

theophylline anhydrous (UNII: 0I55128JYK) (theophylline anhydrous - UNII:0I55128JYK)

Available from:

Purdue Pharmaceutical Products LP

INN (International Name):

theophylline anhydrous

Composition:

theophylline anhydrous 400 mg

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

Product summary:

Uniphyl® (theophylline, anhydrous) Controlled-Release Tablets 400 mg are supplied in white, opaque plastic, child-resistant bottles containing 100 tablets (NDC 67781-251-01) or 500 tablets (NDC 67781-251-05). Each round, white 400 mg tablet bears the symbol PF on the scored side and U400 on the other side. Uniphyl® (theophylline, anhydrous) Controlled-Release Tablets 600 mg are supplied in white, opaque plastic, child-resistant bottles containing 100 tablets (NDC 67781-252-01). Each rectangular, concave, white 600 mg tablet bears the symbol PF on the scored side and U 600 on the other side. Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

UNIPHYL- THEOPHYLLINE ANHYDROUS TABLET
PURDUE PHARMACEUTICAL PRODUCTS LP
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UNIPHYL TABLETS
(THEOPHYLLINE, ANHYDROUS)
400 MG AND 600 MG
UNICONTIN
CONTROLLED-RELEASE SYSTEM
DESCRIPTION
Uniphyl
(theophylline, anhydrous) Tablets in a controlled-release system
allows a 24-hour dosing
interval for appropriate patients.
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.
Each controlled-release tablet for oral administration, contains 400
or 600 mg of anhydrous
theophylline.
Inactive Ingredients: cetostearyl alcohol, hydroxyethyl cellulose,
magnesium stearate, povidone and
talc.
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
cha