VERAPAMIL HYDROCHLORIDE tablet, film coated, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bryant Ranch Prepack

INN (Nama Antarabangsa):

VERAPAMIL HYDROCHLORIDE

Komposisi:

VERAPAMIL HYDROCHLORIDE 240 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Verapamil HCl Extended-Release Tablets are indicated for the management of essential hypertension. Verapamil Hydrochloride Extended-Release Tablets are contraindicated in: - Severe left ventricular dysfunction (see WARNINGS ). - Hypotension (systolic pressure less than 90 mmHg) 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 (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS ). - Patients with known hypersensitivity to verapamil hydrochloride.

Ringkasan produk:

Verapamil Hydrochloride Extended-Release Tablets, USP 120 mg are supplied as ivory, round, unscored, film-coated tablets debossed with “120” on one side on the other side, packaged in bottles of 100 tablets and unit-dose boxes of 100 tablets. Verapamil Hydrochloride Extended-Release Tablets USP, 180 mg are supplied as light orange, capsule-shaped, scored, film-coated tablets debossed with “7301” on one side, on the other side, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets. Verapamil Hydrochloride Extended-Release Tablets USP, 240 mg are supplied as ivory, capsule-shaped, scored, film-coated tablets debossed with “7300” on one side, on the other side, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets. Store between 20˚ to 25˚ C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT AND MOISTURE. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. You may report side effects to FDA at 1-800-FDA-1088 . TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 4/2012

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
VERAPAMIL HCL EXTENDED-RELEASE TABLETS USP
RX ONLY
DESCRIPTION
Verapamil hydrochloride is a calcium ion influx inhibitor (slow
channel blocker or calcium ion
antagonist).
The tablets are designed for extended-release of the drug in the
gastrointestinal tract; extended-release
characteristics are not altered when the tablet is divided in half.
Verapamil hydrochloride is chemically designated as
Benzeneacetonitrile, α-[3-[[2-(3,4-
dimethoxyphenyl)ethyl]-methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)-monohydrochloride
and
has the following structural formula:
C
H N O ●HCl M.W. 491.07
Verapamil hydrochloride is a white or practically white crystalline
powder, practically odorless with a
bitter taste. It is soluble in water, methanol, and chloroform.
Verapamil hydrochloride is not chemically
related to other cardioactive drugs.
Each extended-release tablet, for oral administration, contains 240
mg, 180 mg or 120 mg verapamil
hydrochloride. In addition to verapamil hydrochloride the tablets
contain the following inactive
ingredients: magnesium stearate, microcrystalline cellulose, povidone
and sodium alginate. The coating
for verapamil 240 mg tablets contains: D&C Yellow No. 10 aluminum
lake, hydroxypropyl cellulose,
hypromellose, polyethylene glycol and titanium dioxide. The coating
for verapamil 180 mg tablets
contains: FD&C Yellow No. 6 aluminum lake, hypromellose, polyethylene
glycol, polysorbate 80 and
titanium dioxide. The coating for verapamil 120 mg tablets contains:
hypromellose, polydextrose
powder, polyethylene glycol, titanium dioxide, triacetin and yellow
iron oxide.
All three strengths: 120 mg, 180 mg, and 240 mg meet USP Drug Release
Test #2.
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