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:

Physicians Total Care, Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil hydrochloride 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.

Product summary:

Verapamil Hydrochloride Extended-release Tablets, USP are available containing 120 mg, 180 mg or 240 mg of verapamil hydrochloride, USP. The 120 mg tablets are blue film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 244 on the other side. They are available as follows: NDC 54868-4432-0 bottles of 30 tablets The 180 mg tablets are blue film-coated, oval tablets debossed with M to the left of the score and 312 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 54868-3300-2 bottles of 30 tablets NDC 54868-3300-3 bottles of 60 tablets NDC 54868-3300-4 bottles of 90 tablets NDC 54868-3300-1 bottles of 100 tablets The 240 mg tablets are blue film-coated, modified capsule-shaped tablets debossed with M to the left of the score and 411 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 54868-2207-6 bottles of 10 tablets NDC 54868-2207-2 bottles of 30 tablets NDC 54868-2207-0 bottles of 60 tablets NDC 54868-2207-5 bottles of 90 tablets NDC 54868-2207-3 bottles of 100 tablets NDC 54868-2207-7 bottles of 180 tablets Store at 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 using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED AUGUST 2010 VERAT:R5 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma         74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
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.
The structural formula of verapamil hydrochloride is given below:
C
H N O • HCL M.W. = 4 91.07
(±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile
monohydrochloride
Verapamil hydrochloride, USP is an almost white, crystalline powder,
practically free of odor, with a
bitter taste. It is soluble in water, chloroform and methanol.
Verapamil hydrochloride is not chemically
related to other cardioactive drugs.
Each extended-release tablet, for oral administration, contains 120
mg, 180 mg or 240 mg of verapamil
hydrochloride. In addition, each tablet contains the following
inactive ingredients: FD&C Blue No. 1
Aluminum Lake, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl
alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and
titanium dioxide.
Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet _USP
Dissolution Test 1_.
Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240
mg meet _USP Dissolution_
_Test 3_.
CLINICAL PHARMACOLOGY
Verapamil hydrochloride 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 antihypertensive effects by decreasing systemic
vascular resistance, usually without
orthostatic decreases in blood pressure or reflex tachycardia;
bradycardia (rate less than 50 beats/min)
is uncommon (1.4%).