Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
ISRADIPINE (UNII: YO1UK1S598) (ISRADIPINE - UNII:YO1UK1S598)
AvKARE
ORAL
PRESCRIPTION DRUG
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.
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)
Abbreviated New Drug Application
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 Baca dokumen lengkapnya