Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
NIMODIPINE (UNII: 57WA9QZ5WH) (NIMODIPINE - UNII:57WA9QZ5WH)
Caraco Pharmaceutical Laboratories, Ltd.
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.
Nimodipine capsules 30 mg are clear yellow solution filled in oblong opaque light yellow softgel capsules, imprinted “135” in black ink. The capsules are available as follows: NDC 57664-135-64 Unit Dose Blisters of 30 (6 x 5) NDC 57664-135-65 Unit Dose Blisters of 100 (4 x 25) 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. For Institutional Use Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Abbreviated New Drug Application
NIMODIPINE - NIMODIPINE CAPSULE CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- DO NOT ADMINISTER NIMODIPINE 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 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 USP in a vehicle of glycerin, peppermint oil, purified water and polyethylene glycol. The soft gelatin shell contains gelatin, D&C Yellow #10, glycerin, titanium dioxide and purified water. The ingredients in the edible imprinting ink contain ammonium hydroxide, black iron oxide, n-butyl alcohol, isopropyl alcohol, shellac glaze in ethanol and propylene glycol. In addition, the capsule may contain trace amounts of fractionated coconut oil. 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 lipophilic, 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 Διαβάστε το πλήρες έγγραφο