VERAPAMIL HYDROCHLORIDE- verapamil hydrochloride tablet, film coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Unit Dose Services

INN (Tên quốc tế):

VERAPAMIL HYDROCHLORIDE

Thành phần:

VERAPAMIL HYDROCHLORIDE 240 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Verapamil hydrochloride extended-release tablets USP 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 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 pharma

Tóm tắt sản phẩm:

Product: 50436-6914 NDC: 50436-6914-1 10 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 50436-6914-3 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
UNIT DOSE SERVICES
----------
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP
RX ONLY
DESCRIPTION
Verapamil hydrochloride extended-release tablets USP are calcium ion
influx inhibitor (slow channel
blocker or calcium ion antagonist). Verapamil hydrochloride
extended-release tablets USP are available
for oral administration as brown colored, oval, biconvex, film-coated
tablets containing 120 mg
verapamil hydrochloride USP, as brown colored, oval, biconvex,
film-coated tablets containing 180 mg
verapamil hydrochloride USP, and as brown colored, oval, biconvex,
film-coated tablets containing 240
mg 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 given below:
C
H N O ·HCl..........M.W. 491.06
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.
In addition to verapamil HCl USP, the verapamil hydrochloride
extended-release tablets USP contain
the following ingredients: colloidal silicon dioxide, sodium alginate,
hypromellose, magnesium
stearate, microcrystalline cellulose, povidone, polyethylene glycol
and titanium dioxide. The following
are the color additives per tablet strength:
Strength (mg)
Color Additive(s)
120
Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black
180
Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black
240
Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black
Verapamil hydrochloride extended-release tablets USP, 120 mg, 180 mg
and 240 mg meet USP
Dissolution Test 1.
CLINICAL PHARMACOLOGY