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:

NCS HealthCare of KY, Inc dba Vangard Labs

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 Hydrochloride Tablets are contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS) 2. Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) 4. Second-or-third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) 5. Patients with atrial flutter or atrial fibrillation and an

Product summary:

Verapamil Hydrochloride Tablets USP, 80 mg white, scored tablets, debossed with WATSON 343 are available in blistercards of 30. Verapamil Hydrochloride Tablets USP, 120 mg white, scored tablets, debossed with WATSON 345 are available in blistercards of 30. Dispense in a tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: November 2008                1108B                                                         174388

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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VERAPAMIL HYDROCHLORIDE TABLETS USP
REVISED: NOVEMBER 2008
RX ONLY 174388
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. Verapamil hydrochloride is not chemically
related to other cardioactive
drugs.
The structural formula of verapamil hydrochloride is:
Benzeneacetonitrile,
α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-
methylethyl)-, monohydrochloride, (±)−
Verapamil hydrochloride is a white or practically white, crystalline
powder. It is practically odorless
and has a bitter taste. It is soluble in water, methanol, and
chloroform.
The inactive ingredients are 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, 80 mg light peach and 120 mg peach);
hydroxypropyl cellulose and titanium
dioxide (40 mg white, 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 inhibi