NIMODIPINE capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

ANI Pharmaceuticals, Inc.

INN (International Nazwa):

NIMODIPINE

Skład:

NIMODIPINE 30 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Nimodipine Capsules are available as: 30 mg:  White, soft-gelatin, oblong-shape capsule. It contains a yellow solution; printed with ‘ANI 210’ in red ink. Unit Dose Package of 30 (10 x 3):       NDC 62559-210-31 Unit Dose Package of 100 (10 x 10):   NDC 62559-210-81 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.   Manufactured by: USGP, a division of Procaps S.A. Barranquilla, Colombia South America    Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9675 Rev 06/19

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

NIMODIPINE- NIMODIPINE CAPSULE
ANI PHARMACEUTICALS, 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 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. Nimodipine
capsules also contain
the following inactive ingredients: peppermint oil, glycerin,
polyethylene glycol, water,
gelatin type A, titanium dioxide, light mineral oil, alcohol, shellac
glaze, _n_-butyl alcohol,
propylene glycol, SDA alcohol, and FD&C red No. 40 aluminum lake.
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
21
26
2
7
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 humans is unknown.
Although the
clinical studies described bel