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언어: 영어
출처: NLM (National Library of Medicine)
NIMODIPINE (UNII: 57WA9QZ5WH) (NIMODIPINE - UNII:57WA9QZ5WH)
Major Pharmaceuticals
NIMODIPINE
NIMODIPINE 30 mg
ORAL
PRESCRIPTION DRUG
Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). The concomitant use of nimodipine with strong inhibitors of CYP3A4 such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some anti-HIV protease inhibitors (e.g., delaviridine, indinavir, nelfinavir, ritonavir, saquinavir), some azole antimycotics (e.g., ketoconazole, itraconazole, voriconazole) and some antidepressants (e.g., nefazadone) is contraindicated because of a risk of significant hypotension (see PRECAUTIONS, Drug Interactions ). There have been no reported instances of drug abuse or dependence with nimodipine capsules.
Nimodipine capsules 30 mg are clear yellow solution filled in oblong gray opaque colored softgel capsules, imprinted “A297” in black ink. The capsules are available as follows: Strength NDC Code Capsule Identification Unit Dose Package of 100 (10 x 10): 30 mg [0904-6566-61] A297 Unit Dose Package of 30 (3 x 10): 30 mg [0904-6566-04] A297 Storage: The capsules should be stored in manufacturer’s original foil package at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Capsules should be protected from light and freezing. Distributed by: Major® Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBER 12/2015 Printed in USA
Abbreviated New Drug Application
NIMODIPINE- NIMODIPINE CAPSULE, LIQUID FILLED MAJOR PHARMACEUTICALS ---------- NIMODIPINE CAPSULES FOR ORAL USE RX ONLY ASCEND LABORATORIES, LLC DO NOT ADMINISTER NIMODIPINE CAPSULES INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS HAVE OCCURRED WHEN THE CONTENTS OF NIMODIPINE CAPSULES HAVE BEEN INJECTED PARENTERALLY (SEE WARNINGS AND DOSAGE AND ADMINISTRATION). DESCRIPTION Nimodipine capsules belongs to the class of pharmacological agents known as calcium channel blockers. Nimodipine is isopropyl 2 – methoxyethyl 1, 4 – dihydro – 2, 6 – dimethyl – 4 – (m- nitrophenyl) – 3, 5 – pyridinedicarboxylate. It has a molecular weight of 418.5 and a molecular formula of C H N O . The structural formula is: Nimodipine is a yellow crystalline substance, practically insoluble in water. Nimodipine capsules are formulated as soft gelatin capsules for oral administration. Each liquid filled capsule contains 30 mg of nimodipine in a vehicle of glycerin, peppermint oil, purified water and polyethylene glycol 400. The soft gelatin capsule shell contains gelatin, glycerin, purified water, titanium dioxide and iron oxide black. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Nimodipine is a calcium channel blocker. The contractile processes of smooth muscle cells are dependent upon calcium ions, which enter these cells during depolarization as slow ionic transmembrane currents. Nimodipine inhibits calcium ion transfer into these cells and thus inhibits contractions of vascular smooth muscle. In animal experiments, nimodipine had a greater effect on cerebral arteries than on arteries elsewhere in the body perhaps because it is highly liphophilic, allowing it to cross the blood-brain barrier; concentrations of nimodipine as high as 12.5 ng/mL have 21 26 2 7 been detected in the cerebrospinal fluid of nimodipine-treated subarachnoid hemorrhage (SAH) patients. The precise mechanism of action of nimodipine in humans is unknown. Although the clinical studies described below demons 전체 문서 읽기