NIMODIPINE- nimodipine capsule, liquid filled

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Major Pharmaceuticals

INN (International Name):

NIMODIPINE

রচনা:

NIMODIPINE 30 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Nimodipine capsules 30 mg are clear yellow solution filled in oblong gray opaque colored softgel capsules, imprinted “A297” in black ink. The capsules are available as follows:                                                 Strength        NDC Code              Capsule Identification Unit Dose Package of 100 (10 x 10):         30 mg             [0904-6566-61]      A297 Unit Dose Package of 30 (3 x 10):             30 mg             [0904-6566-04]      A297 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. Distributed by: Major® Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBER 12/2015                                                                                       Printed in USA

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

NIMODIPINE- NIMODIPINE CAPSULE, LIQUID FILLED
MAJOR PHARMACEUTICALS
----------
NIMODIPINE CAPSULES
FOR ORAL USE
RX ONLY
ASCEND LABORATORIES, LLC
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,
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
21
26
2
7
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 demons