VERAPAMIL HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Bryant Ranch Prepack

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Verapamil hydrochloride extended-release tablets 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 HCl tablets are contraindicated in: - Severe left ventricular dysfunction (see WARNINGS ) - Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock - Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) - Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) - Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (eg, Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS ) - Patients with known hypersensitivity to verapamil hydrochloride

Přehled produktů:

Verapamil hydrochloride extended-release tablets, USP 240 mg are supplied as light blue, capsule shaped, bevelled edged, scored, film coated tablets debossed with C 77 on one side and plain on other side. NDC: 71335-1394-1: 30 Tablets in a BOTTLE NDC: 71335-1394-2: 90 Tablets in a BOTTLE NDC: 71335-1394-3: 60 Tablets in a BOTTLE NDC: 71335-1394-4: 10 Tablets in a BOTTLE NDC: 71335-1394-5: 100 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] and protect from light and moisture. Dispense in tight, light-resistant containers. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 NDC: 71335-1394-1: 30 Tablets in a BOTTLE NDC: 71335-1394-2: 90 Tablets in a BOTTLE NDC: 71335-1394-3: 60 Tablets in a BOTTLE NDC: 71335-1394-4: 10 Tablets in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
VERAPAMIL HYDROCHLORIDE
EXTENDED-RELEASE TABLETS USP
EXTENDED RELEASE
FILM COATED TABLETS
DESCRIPTION
Verapamil hydrochloride extended-release tablets, USP is a calcium ion
influx inhibitor
(slow-channel blocker or calcium ion antagonist). Verapamil
hydrochloride extended-
release tablets, USP is available for oral administration as light
blue, oval shaped, scored,
film coated tablets containing 240 mg of verapamil hydrochloride USP;
as light blue,
capsule shaped, bevelled edged, scored, film coated tablets containing
180 mg of
verapamil hydrochloride USP. The tablets are designed for sustained
release of the drug
in the gastrointestinal tract; sustained-release characteristics are
not altered when the
tablet is divided in half.
The structural formula of verapamil HCl USP is:
C
H
N O ∙ HCl
M.W.=491.08
BENZENEACETONITRILE, Α-[3-[[2-(3,4-
DIMETHOXYPHENYL)ETHYL]METHYLAMINO] PROPYL]-3,4-DIMETHOXY-
Α-(1-METHYLETHYL) HYDROCHLORIDE
Verapamil HCl, USP is an almost white, crystalline powder, practically
free of odor, with a
bitter taste. It is soluble in water, chloroform, and methanol.
Verapamil HCl, USP is not
chemically related to other cardioactive drugs.
Inactive ingredients include colloidal silicon dioxide, hypromellose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone,
sodium alginate, and
film coating contains FD&C Blue No. 1 Brilliant Blue FCF aluminum
lake, hypromellose,
iron oxide yellow, titanium dioxide and triacetin.
Verapamil hydrochloride extended-release tablets USP, 180 mg and 240
mg meet USP
Dissolution Test 3.
CLINICAL PHARMACOLOGY
Verapamil HCl is a calcium ion influx inhibitor (slow-channel blocker
or calcium ion
antagonist) that exerts its pharmacologic effects by modulating the
influx of ionic
27
38
2
4
calcium across the cell membrane of the arterial smooth muscle as well
as in conductile
and contractile myocardial cells.
MECHANISM OF ACTION
Essential hypertension
V