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:

Mylan Pharmaceuticals Inc.

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. Theophylline (anhydrous) extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Product summary:

Theophylline (Anhydrous) Extended-Release Tablets are available containing 400 mg or 600 mg of theophylline, USP. The 400 mg tablet is a white, round, scored tablet, embossed with N over T4 . They are available as follows: NDC 0378-0486-01 bottles of 100 tablets The 600 mg tablet is a white, oblong, scored tablet embossed with NT6 . They are available as follows: NDC 0378-0487-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120 FEBRUARY 2016 NOS:THEOT:R1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE (ANHYDROUS)- THEOPHYLLINE TABLET, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Theophylline (anhydrous) extended-release tablets in a
controlled-release system allows a 24-hour
dosing interval for appropriate patients.
Theophylline, USP 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 400 mg
or 600 mg of anhydrous
theophylline.
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 adenosine-mediated
channel.
SERUM CONCENTRATION-EFFECT RELATIONSHIP
Bron