VERAPAMIL HYDROCHLORIDE tablet, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

구성:

VERAPAMIL HYDROCHLORIDE 120 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 drugs, from a variety of ph

제품 요약:

Each film-coated extended-release tablet for oral administration contains 120 mg, 180 mg, or 240 mg of verapamil hydrochloride, USP. 120 mg: Yellow, oval-shaped, biconvex, film-coated tablets, debossed with “116” on one side and plain on the other side. NDC 57664-116-83    Bottles of 30     CRC NDC 57664-116-88    Bottles of 100   CRC NDC 57664-116-08    Bottles of 100   NDC 57664-116-13    Bottles of 500 NDC 57664-116-18    Bottles of 1000 180 mg : Yellow, oval-shaped, biconvex, film-coated tablets, debossed with “117” on one side and scored on the other side. NDC 57664-117-83    Bottles of 30 CRC NDC 57664-117-88    Bottles of 100 CRC NDC 57664-117-08    Bottles of 100   NDC 57664-117-13    Bottles of 500 NDC 57664-117-18    Bottles of 1000 240 mg : Yellow, capsule-shaped, biconvex, film-coated tablets, debossed with “118” on one side and scored on the other side. NDC 57664-118-83    Bottles of 30 CRC NDC 57664-118-88    Bottles of 100 CRC NDC 57664-118-08    Bottles of 100   NDC 57664-118-13    Bottles of 500 NDC 57664-118-18    Bottles of 1000 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. Distributed by:  Sun Pharmaceutical Industries, Inc.                             Cranbury, NJ 08512 Rev. 10/2017

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, 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 s