VERAPAMIL HYDROCHLORIDE- verapamil hydrochloride tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Mylan Pharmaceuticals Inc.

Designació comuna internacional (DCI):

VERAPAMIL HYDROCHLORIDE

Composición:

VERAPAMIL HYDROCHLORIDE 80 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Verapamil hydrochloride tablets are indicated for the treatment of the following: Angina Arrhythmias Verapamil hydrochloride 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

Resumen del producto:

Verapamil Hydrochloride Tablets, USP are available containing 80 mg or 120 mg of verapamil hydrochloride, USP. The 80 mg tablets are white, film-coated, round tablets debossed with MYLAN above the score and 512 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0512-77 bottles of 90 tablets NDC 0378-0512-01 bottles of 100 tablets The 120 mg tablets are white, film-coated, round tablets debossed with MYLAN above the score and 772 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0772-77 bottles of 90 tablets NDC 0378-0772-01 bottles of 100 tablets NDC 0378-0772-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2017 VER:R10

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Verapamil hydrochloride is a calcium ion influx inhibitor
(slow-channel blocker or calcium ion
antagonist) available for oral administration in film-coated tablets
containing 80 mg or 120 mg of
verapamil hydrochloride.
The structural formula of verapamil hydrochloride is:
C
H N O •HCL M.W. 4 91.07
Benzeneacetonitrile,
α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy
α-(1-
methylethyl) hydrochloride
Verapamil hydrochloride, USP 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.
Inactive ingredients include calcium sulfate, colloidal silicon
dioxide, croscarmellose sodium,
hydroxypropyl cellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, pregelatinized starch (corn), sodium lauryl sulfate, talc and
titanium dioxide.
CLINICAL PHARMACOLOGY
Verapamil hydrochloride tablets are 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
_ANGINA_
The precise mechanism of action of verapamil hydrochloride tablets as
an antianginal agent remains to
be fully determined, but includes the following two mechanisms:
1.
27
38
2
4
_Relaxation and prevention of coronary artery spasm:_ Verapamil
hydrochloride tablets dilate the
main coronary arteries and coronary arterioles, both in normal and
ischemic regions, and is a
potent inhibitor of coronary artery spasm, whether spontaneous or
ergonovine-induced. This
property increases myocardial oxygen delivery in patients with
coronary artery spasm and is
2.
_ARRHYTHMIA_
Electrical activity through the AV node dep