VERAPAMIL HYDROCHLORIDE- 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:

PD-Rx Pharmaceuticals, Inc.

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 - Angina at rest including: Vasospastic (Prinzmetal's variant) angina Unstable (crescendo, pre-infarction) angina - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina - Chronic stable angina (classic effort-associated angina) Arrhythmias - 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) - Prophylaxis of repetitive paroxysmal supraventricular tachycardia 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 thi

Product summary:

Verapamil Hydrochloride Tablets, USP are available containing 120 mg of verapamil hydrochloride, USP. 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 55289-481-30 bottles of 30 tablets NDC 55289-481-60 bottles of 60 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED
PD-RX 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:
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. _ 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 responsible for
the effectiveness of verapamil hydrochloride tablets in vasospastic
(Prinzmetal