TEVA-THEOPHYLLINE SR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

THEOPHYLLINE

Available from:

TEVA CANADA LIMITED

ATC code:

R03DA04

INN (International Name):

THEOPHYLLINE

Dosage:

300MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

THEOPHYLLINE 300MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Prescription

Therapeutic area:

RESPIRATORY SMOOTH MUSCLE RELAXANTS

Product summary:

Active ingredient group (AIG) number: 0103582004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-05-08

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TEVA-THEOPHYLLINE SR
(Theophylline Anhydrous)
100, 200 and 300 mg Tablets (Sustained Release)
Teva Standard
Bronchodilator
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
May 6, 2011
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control No:
147027
2
Pr
TEVA-THEOPHYLLINE SR
(Theophylline Anhydrous)
100, 200 and 300 mg Tablets (Sustained Release)
Teva Standard
THERAPEUTIC CLASSIFICATION
Bronchodilator
AGTION AND CLINICAL PHARMACOLOGY
TEVA-THEOPHYLLINE SR (theophylline) relieves bronchospasm and
increases flow
rates and vital capacity through the relaxation of the smooth muscle
of the bronchial
airways and pulmonary blood vessels. It also produces other actions
typical of the
xanthine derivatives: coronary vasodilation, diuresis, increase in
gastric secretion, and
cardiac, cerebral and skeletal muscle stimulation. The actions of
theophylline may be
mediated through inhibition of phosphodiesterase and the consequent
increase in
intracellular cyclic adenosine monophosphate, but the exact
mechanism(s) has not been
determined.
Theophylline is usually readily absorbed and distributed into all body
compartments.
Protein binding is approximately 55 to 65 %. The primary site of
metabolism is the liver.
The therapeutic serum concentration range commonly accepted is 10 to
20 _µ_g/mL (55 to
110 _µ_g/mL; levels above 20 _µ_g/mL are associated with toxic
reactions. A number of
variables influence the pharmacokinetics of theophylline. These
include age, disease
state, smoking and concomitant medications. Therefore, the optimum
therapeutic
maintenance dose should be determined by individual titration.
TEVA-THEOPHYLLINE SR (theophylline) are sustained release tablets
which produce
blood levels between 5 to 8 hours after dosing in adults and between 4
to 6 hours after
dosing in children 6 years of age and older. Once the steady state
level has been reached
(3 days), the therapeutic blood levels persist for 12 hours in most
adult patients. The
mean elimination half-life of theophylline in nonsmoking