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:

Actavis Pharma, Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 80 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:

Verapamil Hydrochloride Tablets USP, 40 mg light peach film-coated tablets, debossed with WATSON 404 are available in bottles of 100. Verapamil Hydrochloride Tablets USP, 80 mg white, scored film-coated tablets, debossed with WATSON 343 are available in bottles of 100, 500, and 1000. Verapamil Hydrochloride Tablets USP, 120 mg white, scored film-coated tablets, debossed with WATSON 345 are available in bottles of 100, 500, and 1000. Bottles of 100 are supplied with child-resistant closures. Dispense in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA  Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA  Revised: November 2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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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
del