VERAPAMIL HYDROCHLORIDE tablet, film coated, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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 a break line on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture and store in a dry place. Keep tablets in original/pharmacy container. 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 Pharmaceuticals Inc., USA at 1 [phone]. Manufactured by: Glenmark Pharmaceuticals Limited Plot No. S-7, Colvale Industrial Estate Colvale - Bardez, Goa-403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com November 2019

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS
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:
1. C
H
N
O
·HCl M.W. 491.06 g/mol
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, freely soluble in chloroform,
sparingly soluble in alcohol
and practically insoluble in ether. Verapamil HCl, USP is not
chemically related to other
cardio active drugs.
In addition to verapamil HCl, USP, the Verapamil Hydrochloride
Extended-Release
Tablets, USP contain the following inactive ingredients: colloidal
silicon dioxide,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol,
povidone, sodium alginate, 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
27
38
2
4
240
Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black
V