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Nimotop (Nimodipine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Nimotop (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)

DOSAGE AND ADMINISTRATION

DO NOT ADMINISTER NIMOTOP CAPSULES INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES (see WARNINGS). If Nimotop 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.

Nimotop is given orally in the form of ivory colored, soft gelatin 30 mg capsules for subarachnoid hemorrhage.

Unless otherwise prescribed, the 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. Grapefuit juice is to be avoided (See PRECAUTIONS, Drug Interactions). Oral Nimotop therapy should commence as soon as possible or within 96 hours of the diagnosis of subarachnoid hemorrhage (aSAH).

Duration of use:

Nimodipine capsules may be used during anaesthesia or surgical procedures. In the event of surgical invention, administration of nimodipine should be continued, with dosages as above, to complete the 21 day period.

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%). The efficacy and safety of this method of administration has not been demonstrated in clinical trials.

In patients who develop adverse reactions the dose should be reduced as necessary or the treatment discontinued.

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 effects and side-effects, e.g. reduction in blood pressure, 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.

Upon co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers a dose adjustment may be necessary.

HOW SUPPLIED

Each ivory colored, soft gelatin NIMOTOP capsule is imprinted with the word Nimotop and contains 30 mg of nimodipine. The 30 mg capsules are packaged in unit dose foil pouches and supplied in cartons containing 100 capsules. The product is also available in child resistant unit dose safety pak foil pouches containing 30 capsules per carton. The capsules should be stored in the manufacturer’s original foil package at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [See USP controlled Room Temperature.]

Capsules should be protected from light and freezing.

StrengthNDC CodeCapsule Identification
Unit Dose
Package of 100:

30 mg

50419-855-48

Nimotop
Unit Dose
Package of 30:

30 mg

50419-855-70

Nimotop

Distributed by:

Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470

Manufactured by:

Catalent Pharma Solutions
St. Petersburg, FL 33716

Rx Only

809096681/08BAY e 97365202-7-A-U.S.-14

©2007 Bayer HealthCare Pharmaceuticals Inc.13771Printed in USA

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