NIMODIPINE capsule, liquid filled

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

NIMODIPINE (UNII: 57WA9QZ5WH) (NIMODIPINE - UNII:57WA9QZ5WH)

Verfügbar ab:

BIONPHARMA INC.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Nimodipine Capsules 30 mg - Oblong, white opaque, soft gelatin capsules in Printed NM1 in black ink. The capsules should be stored in the manufacturer’s original package. Store at 20°to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Capsules should be protected from light and freezing. Distributed by: Bionpharma Inc. 600 Alexander Road, Princeton, NJ 08540 Rev. 01/20

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NIMODIPINE- NIMODIPINE CAPSULE, LIQUID FILLED
BIONPHARMA INC.
----------
NIMODIPINE CAPSULES
FOR ORAL USE
RX ONLY
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 ANDDOSAGE 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. In addition the
capsules contain the
following inactive ingredients: gelatin, glycerin, hypromellose, iron
oxide black, kosher
glycerin, mannitol, peppermint oil, polyethylene glycol, propylene
glycol, sorbitol, sorbitol
21
26
2
7
glycerin, mannitol, peppermint oil, polyethylene glycol, propylene
glycol, sorbitol, sorbitol
anhydrides and titanium dioxide.
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 been detected
in the
cerebrospinal fluid of nimodipine-treated subarachnoid hemorrhage
(SAH) patients.
The precise mechanism of action of nimodipine in