ISRADIPINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISRADIPINE (UNII: YO1UK1S598) (ISRADIPINE - UNII:YO1UK1S598)

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

ISRADIPINE

Composition:

ISRADIPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isradipine capsules are indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics. Isradipine is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.

Product summary:

Isradipine Capsules, USP 2.5 mg are Filled Gelatin Capsules Size #3, Cap: White Opaque/Body: White Opaque with Imprint "A-263" on cap and body. Available in bottles of 100's (NDC 60429-385-01) Isradipine Capsules, USP 5 mg are Filled Gelatin Capsules Size #3, Cap: Flesh Opaque/Body: Flesh Opaque with Imprint "A-264" on cap and body. Available in bottles of 100's (NDC 60429-386-01). Store 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. Manufactured By: Elite Laboratories, Inc. Northvale, NJ 07647 Distributed By: Epic Pharma, LLC. Laurelton, NY 11413 Manufactured in USA Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012 Revised November 2014 MF263REV11/14 OE1511

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISRADIPINE- ISRADIPINE CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
ISRADIPINE CAPSULES, USP
2.5 MG AND 5 MG
RX ONLY
DESCRIPTION
Isradipine is a calcium antagonist available for oral administration
in capsules containing 2.5 mg or 5
mg. The structural formula of isradipine is:
Chemically, isradipine is 3,5-Pyridinedicarboxylic acid,
4-(4-benzofurazanyl)-1,4-dihydro-2,6-
dimethyl-,methyl 1-methylethyl ester. Isradipine is a yellow, fine
crystalline powder which is odorless
or has a faint characteristic odor. Isradipine is practically
insoluble in water (<10 mg/L at 37°C), but is
soluble in ethanol and freely soluble in acetone, chloroform and
methylene chloride.
_Active Ingredient: _isradipine
_Inactive Ingredients: _colloidal silicon dioxide, corn starch,
gelatin, lactose monohydrate,
microcrystalline cellulose, polyethylene glycol, red iron oxide (5
mg), sodium lauryl sulfate, and
titanium dioxide.
Black ink contains the following ingredients: Black Iron Oxide, D&C
Yellow #10 Aluminum Lake,
FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40
Aluminum Lake, n-
Butyl Alcohol, Propylene Glycol, and Shellac Glaze in SD-45 Alcohol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Isradipine is a dihydropyridine calcium channel blocker. It binds to
calcium channels with high affinity
and specificity and inhibits calcium flux into cardiac and smooth
muscle. The effects observed in
mechanistic experiments _in vitro _and studied in intact animals and
man are compatible with this mechanism
of action and are typical of the class.
Except for diuretic activity, the mechanism of which is not clearly
understood, the pharmacodynamic
effects of isradipine observed in whole animals can also be explained
by calcium channel blocking
activity, especially dilating effects in arterioles which reduce
systemic resistance and lower blood
pressure, with a small increase in resting heart rate. Although like
other dihydropyridine calcium
channel blockers, isradipine has negative inotropic effects _in
vitro_, studies condu