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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil hydrochloride extended-release tablets 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 pharmacolo

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 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 0378-2120-01 bottles of 100 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 0378-2180-01 bottles of 100 tablets NDC 0378-2180-05 bottles of 500 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 0378-1411-77 bottles of 90 tablets NDC 0378-1411-01 bottles of 100 tablets NDC 0378-1411-05 bottles of 500 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 U.S.A. REVISED: 11/2019 VERAT:R12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 uncom