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:

State of Florida DOH Central Pharmacy

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil hydrochloride extended-release tablets USP are indicated for the management of essential hypertension. Verapamil hydrochloride is contraindicated in:

Product summary:

Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side. Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side. Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. You may report side effects to FDA at 1-800-FDA-1088 or Glenmark Generics Inc.,USA at 1 [phone].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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.
C