VERELAN CAPSULE (SUSTAINED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VERAPAMIL HYDROCHLORIDE

MAH:

RECRO GAINESVILLE LLC

ATC_code:

C08DA01

INN:

VERAPAMIL

dosage:

120MG

pharmaceutical_form:

CAPSULE (SUSTAINED-RELEASE)

composition:

VERAPAMIL HYDROCHLORIDE 120MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0113846001; AHFS:

authorization_status:

APPROVED

authorization_date:

2015-06-03

SPC

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