VERAPAMIL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 cl

Product summary:

Product: 50090-0156 NDC: 50090-0156-0 100 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
----------
VERAPAMIL HYDROCHLORIDE TABLETS, USP 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) tablets, USP 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 HCl is:
C
H
N
O
• 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:
1. _Relaxation and prevention of coronary artery spasm:_ Verapamil
hydrochloride dilates the main
coronary arteries and coronary arterioles, both in normal and ischemic
regions, and is a potent inhibitor
of coron