NIMODIPINE- nimodipine capsule, liquid filled

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Cardinal Health

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

Nimodipine Capsules 30 mg - Oblong, white opaque, soft gelatin capsules in Overbagged with 10 capsules per bag NDC 55154-4184-0 The capsules should be stored in the manufacturer’s original package. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Capsules should be protected from light and freezing. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265 Distributed by: Cardinal Health Dublin, OH 43017 L51227260318 Iss. 02/2014

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NIMODIPINE- NIMODIPINE CAPSULE, LIQUID FILLED
CARDINAL HEALTH
----------
NIMODIPINE CAPSULES
FOR ORAL USE
RX ONLY
BOXED WARNING
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. 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 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 humans is unknown.
Although the clinical studies
described below demonstrate a favorab