ISRADIPINE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Carilion Materials Management

INN (Medzinárodný Name):

ISRADIPINE

Zloženie:

ISRADIPINE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Isradipine is 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.

Prehľad produktov:

NDC:68151-1333-0 in a PACKAGE of 1 CAPSULES

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ISRADIPINE- ISRADIPINE CAPSULE
CARILION MATERIALS MANAGEMENT
----------
ISRADIPINE CAPSULES, USP
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 37ºC), but is
soluble in ethanol and freely soluble in acetone, chloroform and
methylene chloride.
isradipine _Active Ingredient:_
colloidal silicon dioxide, red iron oxide (2.5 mg capsule only, yellow
iron oxide, gelatin, anhydrous
lactose, magnesium stearate, sodium lauryl sulfate, starch (corn),
titanium dioxide, black ink: black iron
oxide, shellac and potassium hydroxide. _Inactive Ingredients:_
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 and studied in intact animals and man are
compatible with this mechanism of
action and are typical of the class. _in vitro_
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 studies
conducted in intact anesthetized
animals have shown that the vasodilating effect occurs at doses lower
than those which affect
contractility. In patients with normal ventricular function,
isradipine’s afterload reducing properties