NIMODIPINE capsule, liquid filled

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

American Health Packaging

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 capsules.

Podsumowanie produktu:

Nimodipine capsules 30 mg are clear yellow solution filled in oblong gray opaque colored softgel capsules, laser imprinted “A297”. The capsules are available in the following: Unit dose packages of 20 (5 x 4) NDC 68084-912-32 Unit dose packages of 100 (25 x 4) NDC 68084-912-31 Storage: The capsules should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Capsules should be protected from light and freezing. FOR YOUR PROTECTION: Do not use if blister is torn or broken. American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Ascend Laboratories LLC as follows: (30 mg / 20 UD) NDC 68084-912-32 packaged from NDC 67877-297 (30 mg / 100 UD) NDC 68084-912-31 packaged from NDC 67877-297 Distributed by: American Health Packaging Columbus, OH 43217 8291232/0618

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

NIMODIPINE- NIMODIPINE CAPSULE, LIQUID FILLED
AMERICAN HEALTH PACKAGING
----------
NIMODIPINE CAPSULES
FOR ORAL USE
8291232/0618
RX ONLY
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,
21
26
2
7
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 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 demonstrate a f