Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
ATENOLOL
SEPTA PHARMACEUTICALS INC
C07AB03
ATENOLOL
100MG
TABLET
ATENOLOL 100MG
ORAL
30/100/500
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0113847001; AHFS:
APPROVED
2011-06-16
1 PRODUCT MONOGRAPH PR SEPTA-ATENOLOL Atenolol Tablets, BP 25, 50 and 100 mg Beta-adrenergic receptor blocking agent Septa Pharmaceuticals Inc., Date of Preparation: 6460 Van Deemter Court, June 7, 2011 Mississauga, Ontario Canada L5T 1S1 Control#: 147538 2 PRODUCT MONOGRAPH NAME OF DRUG Pr SEPTA-ATENOLOL Atenolol Tablets, BP 25mg, 50mg and 100 mg THERAPEUTIC CLASSIFICATION Beta-adrenergic receptor blocking agent ACTION AND CLINICAL PHARMACOLOGY Atenolol is a beta 1 -selective, beta adrenergic blocking agent, devoid of membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities. It is a racemic mixture and the beta 1 properties reside in the S (-) enantiomer. Beta 1 -selectivity decreases with increasing dose. The mechanism of the antihypertensive effect has not been established. Among the factors that may be involved are: (a) competitive ability to antagonize catecholamine-induced tachycardia at the ß-receptor sites in the heart, thus decreasing cardiac output (b) inhibition of renin release by the kidneys (c) inhibition of the vasomotor centres The mechanism of the anti-anginal effect is also uncertain. An important factor may be the reduction of myocardial oxygen requirements by blocking catecholamine-induced increase in heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction. In man atenolol reduces both isoproterenol-and exercise-induced increases in heart rate over the dose range of 50 to 200 mg. At an oral dose of 100 mg the ß1 -blocking effects persist for at least 24 hours; the reduction in exercise-induced heart rate increase being about 32% and 13%, 2 and 24 hours after dosing, respectively. The logarithm of the plasma atenolol level correlates with the degree of ß1 -blockade but not with the antihypertensive effect. 3 PHARMACOKINETICS Approximately 40 to 50 % of an oral dose of atenolol is absorbed from the gastrointestinal tract, the remainder being excreted unchanged in the feces. Peak plasma concentrations occur 2 to 4 hours after dosing and Perskaitykite visą dokumentą