Drug Catalog - Product Detail
NIMODIPINE 30MG CAP 30
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
23155-0512-30 | AVET PHARMACEUTICALS | 30 | 30MG | CAPSULE |
PACKAGE FILES




Generic Name
NIMODIPINE
Substance Name
NIMODIPINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077811
Description
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 21 H 26 N 2 O 7 . 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 and polyethylene glycol. The gelatin shell contains FD&C Yellow No. 6 Aluminum Lake, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, shellac, sorbitol and titanium dioxide. structure
How Supplied
HOW SUPPLIED Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted "HP 512" with black ink. They are supplied as follows: Strength NDC Code Unit Dose Package of 30: (3 blister cards; each containing 10 capsules) 30 mg 23155-512-30 Unit Dose Package of 100: (10 blister cards; each containing 10 capsules) 30 mg 23155-512-00 The capsules should be stored in the manufacturer's original package. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Capsules should be protected from light and freezing. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000272US03 Revised: 06/2024 avet-logo
Indications & Usage
INDICATIONS AND USAGE 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 to V).
Dosage and Administration
DOSAGE AND ADMINISTRATION DO NOT ADMINISTER NIMODIPINE CAPSULES INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES (see WARNINGS ). If nimodipine is inadvertently administered intravenously, clinically significant hypotension may require cardiovascular support with pressor agents. Specific treatments for calcium channel blocker overdose should also be given promptly. Nimodipine is given orally in the form of soft gelatin 30 mg capsules for subarachnoid hemorrhage. The recommended oral dose is 60 mg (two 30 mg capsules) every 4 hours for 21 consecutive days. In general, the capsules should be swallowed whole with a little liquid, preferably not less than one hour before or two hours after meals. Grapefruit juice is to be avoided (see PRECAUTIONS, Drug Interactions ). Oral nimodipine therapy should commence as soon as possible within 96 hours of the onset of subarachnoid hemorrhage. If the capsule cannot be swallowed, e.g., at the time of surgery, or if the patient is unconscious, a hole should be made in both ends of the capsule with an 18 gauge needle, and the contents of the capsule extracted into a syringe. A parenteral syringe can be used to extract the liquid inside the capsule, but the liquid should always be transferred to a syringe that cannot accept a needle and that is designed for administration orally or via a naso-gastric tube or PEG. To help minimize administration errors, it is recommended that the syringe used for administration be labeled "Not for IV Use". The contents should then be emptied into the patient's in situ naso-gastric tube and washed down the tube with 30 mL of normal saline (0.9%). Severely disturbed liver function, particularly liver cirrhosis, may result in an increased bioavailability of nimodipine due to a decreased first pass capacity and a reduced metabolic clearance. The reduction in blood pressure and other adverse effects may be more pronounced in these patients. Dosage should be reduced to one 30 mg capsule every 4 hours with close monitoring of blood pressure and heart rate; if necessary, discontinuation of the treatment should be considered. Strong inhibitors of CYP3A4 should not be administered concomitantly with nimodipine (see CONTRAINDICATIONS ). Strong inducers of CYP3A4 should generally not be administered with nimodipine (see WARNINGS ). Patients on moderate and weak inducers of CYP3A4 should be closely monitored for lack of effectiveness, and a nimodipine dose increase may be required. Patients on moderate and weak CYP3A4 inhibitors may require a nimodipine dose reduction in case of hypotension (see PRECAUTIONS, Drug Interactions ).