Riik: Kanada
keel: inglise
Allikas: Health Canada
PINDOLOL
SANDOZ CANADA INCORPORATED
C07AA03
PINDOLOL
10MG
TABLET
PINDOLOL 10MG
ORAL
100
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0112362003; AHFS:
CANCELLED POST MARKET
2017-05-26
_Sandoz Pindolol _ _ _ _Page 1 of 30 _ PRODUCT MONOGRAPH PR SANDOZ PINDOLOL (Pindolol tablets U.S.P.) Tablets 5, 10 and 15 mg Antihypertensive / Antianginal agent Sandoz Canada Inc. 145 Jules-Léger Date of Revision: February 2, 2012 Boucherville, QC, Canada J4B 7K8 Submission Control No.: 152699 _Sandoz Pindolol _ _ _ _Page 2 of 30 _ PR SANDOZ PINDOLOL (PINDOLOL TABLETS U.S.P.) TABLETS 5, 10 AND 15 MG THERAPEUTIC CLASSIFICATION Antihypertensive/Antianginal Agent ACTIONS Sandoz Pindolol is a ß-adrenergic-receptor-blocking agent which possesses partial agonist activity (intrinsic sympathomimetic activity - I.S.A.). It is used in the treatment of hypertension and/or the prophylaxis of angina pectoris. Hypertension The mechanism of the antihypertensive effect of pindolol 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) a reduction in total peripheral resistance c) inhibition of the vasomotor centres d) inhibition of renin release by the kidneys Angina Pectoris The mechanism of the antianginal effect of pindolol has not been established. Sandoz Pindolol may reduce the oxygen requirement of the heart at any level of effort by blocking catecholamine- induced increases in the heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction. However, oxygen requirements may be increased by such actions as increases in left ventricular fibre length, end diastolic pressure and the systolic ejection period. When the net effect is beneficial in patients with angina, it manifests itself during exercise or stress by delaying the onset of pain and reducing the incidence and severity of anginal attacks. In man, orally-administered pindolol is rapidly and almost completely absorbed (≥95%) from the gastrointestinal tract. The mean absolute bioavailability after oral administration is about 87- 92%. Plasma levels of 10 to 30 nanogram/mL are Lugege kogu dokumenti