VERAPAMIL HYDROCHLORIDE tablet, film coated, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NuCare Pharmaceuticals,Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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. 120 mg: Bottles of 90 - NDC 68462-292-90 Bottles of 100 - NDC 68071-3446-0 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 February 2022

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
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
(equivalent to 111.08 mg verapamil free base), as brown colored, oval,
biconvex, film-
coated tablets containing 180 mg verapamil hydrochloride, USP
(equivalent to 166.62
mg verapamil free base), and as brown colored, oval, biconvex,
film-coated tablets
containing 240 mg verapamil hydrochloride, USP (equivalent to 222.16
mg verapamil
free base). 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)
27
38
2
4
120
Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black
180
Ferr