THEOPHYLLINE (ANHYDROUS)- theophylline tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

THEOPHYLLINE ANHYDROUS

Composition:

THEOPHYLLINE ANHYDROUS 200 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. Theophylline (Anhydrous) Extended-Release Tablets is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Product summary:

Theophylline (Anhydrous) Extended-Release Tablets 200 mg are supplied as elliptical, white, bisected, uncoated tablets, embossed with “PLIVA 482”. Theophylline (Anhydrous) Extended-Release Tablets 300 mg are supplied as capsule, white, bisected, uncoated tablets, embossed with “PLIVA 459”. They are supplied by State of Florida DOH Central Pharmacy as follows: Store  at  25°C  (77°F);  excursions  permitted  between  15°-30°C  (59°-86°F).  (See  USP  Controlled Room Temperature) Dispense in tight, light-resistant container as defined in the USP. Manufactured by: PLIVA Inc. Pomona, NY 10970 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE (ANHYDROUS)- THEOPHYLLINE TABLET, EXTENDED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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THEOPHYLLINE (ANHYDROUS) EXTENDED-RELEASE TABLETS
DESCRIPTION
Theophylline (Anhydrous) Extended-Release 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 Extended-Release tablet for oral administration, contains 200 or
300 mg of anhydrous
theophylline per tablet.
Inactive ingredients: glyceryl behenate, silicified microcrystalline
cellulose, silicon dioxide, and
magnesium stearate.
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 adenosi