VERAPAMIL HYDROCHLORIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

REMEDYREPACK INC.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 extended-release 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 (eg, Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS )  6.Patients with known hypersensitivity to verapamil hydrochloride

Proizvod sažetak:

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: 70518-3533-00 NDC: 70518-3533-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH 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 and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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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, capsule shaped,
bevelled edged, scored, film coated tablets containing 240 mg of
verapamil
hydrochloride USP; as light blue, oval shaped, scored, film coated
tablets containing 180
mg of verapamil hydrochloride USP; and light blue, oval shaped, film
coated tablets
containing 120 mg of verapamil hydrochloride USP (equivalent to 111.08
mg verapamil
free base). 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:
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, 120 mg, 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
calcium across the cell membrane of the arterial smooth muscle as well
as in conductile
and contractile myocardial cells.
MECHANISM OF ACTION
ESSENTIAL HYPERTENSION: Verapamil exerts