NIMODIPINE - nimodipine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Caraco Pharmaceutical Laboratories, Ltd.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Nimodipine capsules 30 mg are clear yellow solution filled in oblong opaque light yellow softgel capsules, imprinted “135” in black ink. The capsules are available as follows: NDC 57664-135-64                           Unit Dose Blisters of 30 (6 x 5) NDC 57664-135-65                           Unit Dose Blisters of 100 (4 x 25) 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. For Institutional Use Only. Distributed by:            Caraco Pharmaceutical Laboratories, Ltd.                                       Detroit, MI 48202                                       Affiliate of                                       Sun Pharmaceutical Industries, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIMODIPINE - NIMODIPINE CAPSULE
CARACO PHARMACEUTICAL LABORATORIES, LTD.
----------
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 in a vehicle of glycerin,
peppermint oil, purified water and
polyethylene glycol. The soft gelatin shell contains gelatin, D&C
Yellow #10, glycerin, titanium
dioxide and purified water. The ingredients in the edible imprinting
ink contain ammonium hydroxide,
black iron oxide, n-butyl alcohol, isopropyl alcohol, shellac glaze in
ethanol and propylene glycol. In
addition, the capsule may contain trace amounts of fractionated
coconut oil.
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
21
26
2
7.
been detected in the cerebrospinal fluid of nimodipine-treated
subarachnoid