Nimodipine

NYMALIZE is 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). 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).

Nimodipine is a dihydropyridine calcium channel blocker. The contractile processes of smooth muscle cells are dependent upon calcium ions, which enter these cells during depolarization as slow ionic transmembrane currents. Nimodipine inhibits calcium ion transfer into these cells and thus inhibits contractions of vascular smooth muscle. In animal experiments, nimodipine had a greater effect on cerebral arteries than on arteries elsewhere in the body perhaps because it is highly lipophilic, allowing it to cross the blood-brain barrier, concentrations of nimodipine as high as 12.5 ng/mL have been detected in the cerebrospinal fluid of nimodipine-treated SAH patients. The precise mechanism of action of nimodipine in reducing the incidence and severity of ischemic deficits in adult patients with SAH from ruptured intracranial berry aneurysms is unknown.

Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes. Give one hour before a meal or two hours after a meal. Start dosing within 96 hours of the SAH. Recommended dose is 10 mL (60 mg) every 4 hours for 21 consecutive days. Nasogastric or Gastric Tube Administration: Administer 10 mL (60 mg) every 4 hours with supplied prefilled oral syringe. Refill syringe with 10 mL of 0.9% saline water solution, flush remaining contents from nasogastric or gastric tube into stomach. Patients with Cirrhosis: Reduce dosage to 5 mL (30 mg) every 4 hours.

None. None

Hypotension: Monitor blood pressure. Patients with Cirrhosis: Higher risk of adverse reactions. Monitor blood pressure and pulse. CYP3A4 Strong Inhibitors: May significantly increase risk of hypotension. Concomitant use with NYMALIZE should generally be avoided. CYP3A4 Strong Inducers: May significantly reduce efficacy of nimodipine.

The safety and efficacy of NYMALIZE (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH. NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules. The following clinically significant adverse reaction appears in other sections of the labeling: Hypotension. Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.

Anti-Hypertensives: May increase risk of hypotension. Monitor blood pressure. CYP3A4 Moderate and Weak Inhibitors: May increase risk of hypotension. Dose reduction of NYMALIZE may be needed. Avoid grapefruit juice. CYP3A4 Moderate and Weak Inducers: May reduce efficacy of NYMALIZE. Dose increase may be needed.

Store between 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Do not refrigerate. Protect from light.