ISRADIPINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Epic Pharma, LLC

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 and 500's. 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 and 500's. 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   Manufactured for: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev. 03-2021-00 IN0515

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISRADIPINE- ISRADIPINE CAPSULE
EPIC PHARMA, LLC
----------
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 conducted in intact
ane