Country: Canada
Language: English
Source: Health Canada
VERAPAMIL HYDROCHLORIDE
RECRO GAINESVILLE LLC
C08DA01
VERAPAMIL
180MG
CAPSULE (SUSTAINED-RELEASE)
VERAPAMIL HYDROCHLORIDE 180MG
ORAL
100
Prescription
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Active ingredient group (AIG) number: 0113846004; AHFS:
APPROVED
2015-06-03
1 PRODUCT M O NOGRAPH VERELAN ® Verapamil HCl Sustained Release Capsules 120 mg, 180 mg and 240 mg ANTIHYPERTENSIVE AGENT MANUFACTURED BY: DATE OF REVISION: Recro Gainesville LLC September 21, 2017 1300 Gould Drive Gainesville, Georgia, USA DISTRIBUTED BY: To be determined CONTROL#: 204929 2 PRODUCT MONOGRAPH VERELAN ® Verapamil HCl, Sustained Release Capsules 120 mg 180 mg and 240 mg Antihypertensive Agent ACTIONS AND CLINICAL PHARMACOL OGY Verapamil is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) which exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. MECHANISM OF ACTION IN ESSENTIAL HYPERTENSION: Verapamil HCl exerts antihypertensive effects by inducing peripheral vasodilation and reducing peripheral vascular resistance usually without reflex tachycardia. These effects are mediated by inhibition of calcium ion influx into smooth muscle cells of the arteriolar wall. Verapamil does not blunt hemodynamic response to isometric or dynamic exercise. Compared to baseline verapamil administration did not affect electrolytes, glucose and creatinine. The hypotensive effect of verapamil is not blunted by an increase in sodium intake. PHARMACOKINETICS IMMEDIATE RELEASE FORMULATIONS OF VERAPAMIL: With the immediate release formulations, more than 90% of the orally administered dose of verapamil is absorbed. Because of rapid biotransformation during its first pass through the portal circulation, bioavailability ranges from 20% to 35%. Peak plasma concentrations are reached between 1 and 2 hours after oral administration. Chronic oral administration of 120 mg of verapamil every 6 hours resulted in plasma levels of verapamil ranging from 125 ng/mL to 400 ng/mL, with higher values reported occasionally. A nonlinear correlation between the verapamil dose administered and 3 verapamil plasma levels does exist. In initial dose titration with verapamil a rela Read the complete document