ISRADIPINE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Compra

Scarica Scheda tecnica (SPC)
09-06-2023

Principio attivo:

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

Commercializzato da:

AvKARE

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Isradipine Capsules, USP 2.5 mg Brown opaque, imprinted with “ ” IS 2.5. Bottles of 100 capsules (NDC 42291-062-01) 5 mg Caramel opaque, imprinted with “ ” IS 5. Store and Dispense Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature] and dispense in a tight, light-resistant container Rx Only Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 06/17 AV 05/23 (P)

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

                                ISRADIPINE- ISRADIPINE CAPSULE
AVKARE
----------
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.
_Active Ingredient: _isradipine
_Inactive Ingredients: _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.
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.
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
anesthetized animals have
shown that the vasodilating effect occurs at doses lower than those
which affect
contractility. In patients with norm
                                
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