VERAPAMIL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil Hydrochloride Tablets 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 is 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

Product summary:

NDC: 63629-4337-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 63629-4337-2: 90 Tablets in a BOTTLE, PLASTIC

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
VERAPAMIL HYDROCHLORIDE TABLETS USP
REVISED: NOVEMBER 2014
RX ONLY ​
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 40 mg,
80 mg, or 120 mg of verapamil hydrochloride.
The structural formula of verapamil hydrochloride is:
Benzeneacetonitrile,
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.
Inactive ingredients include anhydrous lactose, corn starch,
hypromellose 2910,
magnesium stearate, microcrystalline cellulose, polacrilin potassium,
and polyethylene
glycol 400. In addition the following coloring agents are used: FD&C
Yellow No. 6
Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg
light peach);
hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg
white).
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:
1_. Relaxation and prevention of coronary artery spasm:_ Verapamil
dilates 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