VERAPAMIL HYDROCHLORIDE tablet, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)

Dostępny od:

PD-Rx Pharmaceuticals, Inc.

INN (International Nazwa):

VERAPAMIL HYDROCHLORIDE

Skład:

VERAPAMIL HYDROCHLORIDE 180 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive d

Podsumowanie produktu:

Each film-coated extended-release tablet for oral administration contains 180 mg of verapamil hydrochloride, USP. 180 mg : Yellow, oval-shaped, biconvex, film-coated tablets, debossed with “117” on one side and scored on the other side. NDC 43063-561-30    Bottles of 30 Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. 5180966 Rev. 10/2017

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PD-RX PHARMACEUTICALS, INC.
----------
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
Verapamil hydrochloride is a calcium ion influx inhibitor
(slow-channel blocker or calcium
ion antagonist). The tablets are designed for extended-release of the
drug in the
gastrointestinal tract, extended-release characteristics are not
altered when the tablet is
divided in half.
The structural formula of verapamil hydrochloride:
C
H
N
O
•HCl M.W.491.06
The chemical name is: Benzeneacetronitrile,
α[3-[[2-(3,4-dimethoxyphenyl)
ethyl]methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl)
hydrochloride
Verapamil hydrochloride is an almost white, crystalline powder,
practically free of odor,
with a bitter taste. It is soluble in water, chloroform, and methanol.
Verapamil
hydrochloride is not chemically related to other cardioactive drugs.
Each film-coated extended-release tablet for oral administration
contains 120 mg, 180
mg, or 240 mg of verapamil hydrochloride, USP. Each tablet contains
the following
inactive ingredients: carnauba wax, D&C yellow #10 aluminum lake,
hypromellose, iron
oxide yellow, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene
glycol 8000, povidone, sodium alginate, titanium dioxide and
triacetin.
Meets USP Dissolution Test 7.
CLINICAL PHARMACOLOGY
Verapamil hydrochloride is a calcium ion influx inhibitor
(slow-channel blocker or calcium
ion antagonist) that 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
_ESSENTIAL HYPERTENSION_:
Verapamil exerts antihypertensive effects by decreasing systemic
vascular resistance,
usually without orthostatic decreases in blood pressure or reflex
tachycardia;
bradycardia (rate less than 50 beats/min) is uncommon (1.4%). During
isometric or
dynamic exercise, verapamil does not alter systolic c