Nimodipine sandbox

Nimodipine sandbox
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Black Box Warning

BOXED WARNING See full prescribing information for complete Boxed Warning. 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).

Overview

Nimodipine sandbox is a Calcium Channel Blocker that is FDA approved for the {{{indicationType}}} of 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. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Hypotension， Diarrhea， Nausea， Headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Subarachnoid Hemorrhage

• Indication (For both capsule and solution)

• 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).

• Dosing information (In capsule)

• 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.
• Recommended dosage: 60 mg (two 30 mg capsules) PO q4h 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)

• Dosing information （In solution）

• Administration Instructions

• Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes. For all routes of administration, begin NYMALIZE within 96 hours of the onset of SAH. Administer one hour before a meal or two hours after a meal for all routes of administration [see Clinical Pharmacology (12.3)].

• Administration by Oral Route

• Recommended oral dosage: 20 mL (60 mg) PO q4h for 21 consecutive days.

• Administration Via Nasogastric or Gastric Tube

• Using the supplied oral syringe labeled "ORAL USE ONLY", administer 20 mL (60 mg) every 4 hours into a nasogastric or gastric tube for 21 consecutive days. For each dose, refill the syringe with 20 mL of 0.9% saline solution and then flush any remaining contents from nasogastric or gastric tube into the stomach.

• Dosage Adjustments in Patients with Cirrhosis

• In patients with cirrhosis, reduce the dosage to 10 mL (30 mg) every 4 hours [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nimodipine sandbox in adult patients.

Non–Guideline-Supported Use

Cluster headache

• Dosing information

• Total daily doses of 60 to 120 mg

Adjunct treatment of Dementia

• Dosing information

• 180 mg/day
• 30 mg PO tid

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Nimodipine sandbox FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nimodipine sandbox in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nimodipine sandbox in pediatric patients.

Contraindications

There is limited information regarding Nimodipine sandbox Contraindications in the drug label.

Warnings

BOXED WARNING See full prescribing information for complete Boxed Warning. 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).

There is limited information regarding Nimodipine sandbox Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Nimodipine sandbox Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Nimodipine sandbox Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Nimodipine sandbox Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Nimodipine sandbox in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nimodipine sandbox in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nimodipine sandbox during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nimodipine sandbox in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Nimodipine sandbox in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Nimodipine sandbox in geriatric settings.

Gender

There is no FDA guidance on the use of Nimodipine sandbox with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nimodipine sandbox with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nimodipine sandbox in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nimodipine sandbox in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nimodipine sandbox in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nimodipine sandbox in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Nimodipine sandbox Administration in the drug label.

Monitoring

There is limited information regarding Nimodipine sandbox Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Nimodipine sandbox and IV administrations.

Overdosage

There is limited information regarding Nimodipine sandbox overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Nimodipine sandbox Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Nimodipine sandbox Mechanism of Action in the drug label.

Structure

There is limited information regarding Nimodipine sandbox Structure in the drug label.

Pharmacodynamics

There is limited information regarding Nimodipine sandbox Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Nimodipine sandbox Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Nimodipine sandbox Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Nimodipine sandbox Clinical Studies in the drug label.

How Supplied

There is limited information regarding Nimodipine sandbox How Supplied in the drug label.

Storage

There is limited information regarding Nimodipine sandbox Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Nimodipine sandbox Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Nimodipine sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Nimodipine sandbox Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Nimodipine sandbox Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.