Nimodipine (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

There have been no reported instances of drug abuse or dependence with nimodipine

OVERDOSAGE

There have been no reports of overdosage from the oral administration of nimodipine. Symptoms of overdosage would be expected to be related to cardiovascular effects such as excessive peripheral vasodilation with marked systemic hypotension. Clinically significant hypotension due to nimodipine overdosage may require active cardiovascular support with pressor agents. Specific treatments for calcium channel blocker overdose should also be given promptly. Since nimodipine is highly protein-bound, dialysis is not likely to be of benefit.

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)

HOW SUPPLIED

Nimodipine Capsules

30 mg — Oblong, white opaque, soft gelatin capsules in

Unit Dose Package of 30 NDC 23155-108-30
Unit Dose Package of 100 NDC 23155-108-00

Printed H108 in black ink.

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

Iss. 02/2014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 23155-108-30
Heritage Pharmaceuticals Inc.
Nimodipine Capsules
30 mg
Rx only
30 Capsules

6fb8ce9c-figure-02
(click image for full-size original)
NIMODIPINE nimodipine capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-108
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIMODIPINE (NIMODIPINE) NIMODIPINE 30 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
FERROSOFERRIC OXIDE
HYPROMELLOSES
GELATIN
PEPPERMINT OIL
POLYETHYLENE GLYCOLS
MANNITOL
PROPYLENE GLYCOL
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code H108
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23155-108-30 3 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK (23155-108-11)
1 NDC:23155-108-11 10 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (23155-108-30)
2 NDC:23155-108-00 10 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK (23155-108-11)
2 NDC:23155-108-11 10 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (23155-108-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076740 03/21/2008
Labeler — Heritage (780779901)
Registrant — Banner Pharmacaps (945494508)
Establishment
Name Address ID/FEI Operations
Banner Pharmacaps 945494508 MANUFACTURE (23155-108)

Revised: 02/2014 Heritage

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