VERAPAMIL HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 240 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS ). - Patients with known hypersensitivity to verapamil hydrochloride.

Product summary:

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. 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 blisterpacks of 30 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 blisterpacks of 30 and 31 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. E 1/2012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 not
chemically related to other cardioactive drugs.
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.
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: sodium alginate, microcrystalline cellulose, povidone,
magnesium stearate. The coating for
verapamil 240 mg tablets contains: hydroxypropyl cellulose,
hypromellose, titanium dioxide,
polyethylene glycol, D&C Yellow No. 10 Aluminum lake. The coating for
verapamil 180 mg tablets
contains: hypromellose, titanium dioxide, polyethylene glycol, FD & C
Yellow No. 6 Aluminum lake,
polysorbate 80. The coating for verapamil 120 mg tablets contains:
hypromellose, titanium dioxide,
polyethylene glycol, polydextrose powder, triacetin, synthetic 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 mem