国家: 加拿大
语言: 英文
来源: Health Canada
DILTIAZEM HYDROCHLORIDE
PRO DOC LIMITEE
C08DB01
DILTIAZEM
120MG
CAPSULE (EXTENDED RELEASE)
DILTIAZEM HYDROCHLORIDE 120MG
ORAL
100
Prescription
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Active ingredient group (AIG) number: 0115863004; AHFS:
CANCELLED POST MARKET
2021-07-27
_Diltiazem TZ _ _Page 1 of 30 _ PRODUCT MONOGRAPH PR DILTIAZEM TZ Diltiazem Hydrochloride Extended-Release Capsules 120 mg, 180 mg, 240 mg, 300 mg and 360 mg Manufacturer’s Standard Antihypertensive/Antianginal Agent PRO DOC LTÉE Date of Revision: 2925, boul. Industriel April 06, 2021 Laval, Québec H7L 3W9 Submission Control No. 249784 _Diltiazem TZ _ _Page 2 of 30 _ PR DILTIAZEM TZ Diltiazem Hydrochloride Extended-Release Capsules 120 mg, 180 mg, 240 mg, 300 mg and 360 mg Antihypertensive/Antianginal Agent ACTION AND CLINICAL PHARMACOLOGY DILTIAZEM TZ (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (calcium entry blocker or calcium ion antagonist). MECHANISM OF ACTION The therapeutic effect of this group of drugs is believed to be related to their specific cellular action of selectively inhibiting transmembrane influx of calcium ions into cardiac muscle and vascular smooth muscle. The contractile processes of these tissues are dependent upon the movement of extracellular calcium into the cells through specific ion channels. Diltiazem blocks transmembrane influx of calcium through the slow channel without affecting, to any significant degree the transmembrane influx of sodium through the fast channel. This results in a reduction of free calcium ions available within cells of the above tissues. Diltiazem does not alter total serum calcium. HYPERTENSION: The antihypertensive effect of diltiazem is believed to be brought about largely by its vasodilatory action on peripheral blood vessels with resultant decrease in peripheral vascular resistance. ANGINA: The precise mechanism by which diltiazem relieves angina has not been fully determined, but it is believed to be brought about largely by its vasodilatory action. In angina of effort it appears that the action of diltiazem is related to the reduction of myocardial oxygen demand. This is probably caused by a decrease in blood pressure brought about by the reduction of peripheral resistance and of heart rate. HEMODYNAMIC AND ELECTROPHYSIOLOGIC 阅读完整的文件