VERAPAMIL HYDROCHLORIDE- verapamil hydrochloride tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Heritage Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

VERAPAMIL HYDROCHLORIDE

Koostumus:

VERAPAMIL HYDROCHLORIDE 80 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Verapamil hydrochloride tablets USP are indicated for the treatment of the following: Angina 1. Angina at rest including: - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract ) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension 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

Tuoteyhteenveto:

Verapamil Hydrochloride Tablets, USP 80 mg tablets are round, standard concave, white film-coated, scored, debossed "HP" above and "26" below on one side and plain on the reverse side, supplied as: Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature] and protect from light. Dispense in a tight, light-resistant container using a child-resistant closure. MANUFACTURED FOR: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000178US07 Issued: 11/17

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET
HERITAGE PHARMACEUTICALS INC.
----------
VERAPAMIL HYDROCHLORIDETABLETS, USP 80 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERAPAMIL HYDROCHLORIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERAPAMIL
HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL:
DESCRIPTION
Verapamil hydrochloride (verapamil HCl) is a calcium ion influx
inhibitor (slow-channel blocker or
calcium ion antagonist) available for oral administration in
film-coated tablets containing 80 mg of
verapamil hydrochloride.
The structural formula of verapamil HCl is:
C27H38N2O4• HCl M.W. = 491.08
Benzeneacetonitrile, a-[3-[[2-(3,4-dimethoxyphenyl)ethyl]
methylamino]propyl]-3,4-dimethoxy-a-(1-
methylethyl) hydrochloride
Verapamil HCl is an almost white, crystalline powder, practically free
of odor, with a bitter taste. It is
soluble in water, chloroform, and methanol. Verapamil HCl is not
chemically related to other
cardioactive drugs.
Inactive ingredients include colloidal silicon dioxide, dibasic
calcium phosphate dihydrate, magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, light
mineral oil, sodium lauryl sulfate,
titanium dioxide and hypromellose.
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
Angina: The precise mechanism of action of verapamil hydrochloride as
an antianginal agent remains to
be fully determined, but includes the following two mechanisms:
ARRHYTHMIA: Electrical activity through the AV node depends, to a
significant degree, upon calcium
influx through the slow channel. By decreasing the influx of calcium,
verapamil hydrochloride
prolongs the effective refractory per