Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
THEOPHYLLINE
TEVA CANADA LIMITED
R03DA04
THEOPHYLLINE
100MG
TABLET (EXTENDED-RELEASE)
THEOPHYLLINE 100MG
ORAL
100/500/1000
Prescription
RESPIRATORY SMOOTH MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0103582002; AHFS:
MARKETED
2011-05-21
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 Belgenin tamamını okuyun