VERAPAMIL HYDROCHLORIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Actavis Pharma, Inc.

INN (Medzinárodný Name):

VERAPAMIL HYDROCHLORIDE

Zloženie:

VERAPAMIL HYDROCHLORIDE 80 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. 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 accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS ) 6. Patients with known hypersensitivity to verapamil hydrochloride.

Prehľad produktov:

Verapamil hydrochloride tablets, USP are available as follows: 40 mg - Round, unscored, light peach film-coated tablets, debossed with WATSON 404 and are available in bottles of 100 (NDC 0591-0404-01). 80 mg - Round, white, scored film-coated tablets, debossed with WATSON 343 and are available in bottles of 100 (NDC 0591-0343-01), 500 (NDC 0591-0343-05), and 1000 (NDC 0591-0343-10). 120 mg - Round, white, scored film-coated tablets, debossed with WATSON 345 and are available in bottles of 100 (NDC 0591-0345-01), 500 (NDC 0591-0345-05), and 1000 (NDC 0591-0345-10). 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 In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 1/2024

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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VERAPAMIL HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Verapamil hydrochloride, 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, USP.
The structural formula of verapamil hydrochloride, USP 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, USP 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 de