These highlights do not include all the information needed to use NYMALIZE ® safely and effectively. See full prescribing information for NYMALIZE.
NYMALIZE (nimodipine) oral solution
Initial U.S. Approval: 1988
INDICATIONS AND USAGE
NYMALIZE is a dihydropyridine calcium channel blocker indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). (
1)
DOSAGE AND ADMINISTRATION
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Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes (2.1)
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Give one hour before a meal or two hours after a meal (2.1)
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Start dosing within 96 hours of the SAH (2.1)
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Recommended dose is 20 mL (60 mg) every 4 hours for 21 consecutive days (2.2)
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Nasogastric or Gastric Tube Administration: Administer 20 mL (60 mg) every 4 hours with supplied oral syringe. Refill syringe with 20 mL of 0.9% saline water solution; flush remaining contents from nasogastric or gastric tube into stomach (2.3)
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Patients with Cirrhosis: Reduce dosage to 10 mL (30 mg) every 4 hours (2.4)
DOSAGE FORMS AND STRENGTHS
Oral solution: 60 mg per 20 mL (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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Hypotension: Monitor blood pressure (5.1)
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Patients with Cirrhosis: Higher risk of adverse reactions. Monitor blood pressure and pulse (5.2)
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CYP3A4 Strong Inhibitors: May significantly increase risk of hypotension. Concomitant use with NYMALIZE should generally be avoided (5.3)
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CYP3A4 Strong Inducers: May significantly reduce efficacy of nimodipine. Concomitant use with NYMALIZE should generally be avoided (5.4)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia (6)
To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Anti-Hypertensives: May increase risk of hypotension. Monitor blood pressure (7.1)
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CYP3A4 Moderate and Weak Inhibitors: May increase risk of hypotension. Monitor blood pressure. Dose reduction of NYMALIZE may be needed. Avoid grapefruit juice. (7.2)
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CYP3A4 Moderate and Weak Inducers: May reduce efficacy of NYMALIZE. Dose increase may be needed (7.3)
USE IN SPECIFIC POPULATIONS
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Pregnancy: Based on animal data may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2013