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Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
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).
History
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Other Information
NYMALIZE contains nimodipine, a dihydropyridine calcium channel blocker. Nimodipine is isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate. It has a molecular weight of 418.5 and a molecular formula of C21H26N2O7. The structural formula is:
Nimodipine is a yellow crystalline substance, practically insoluble in water.
NYMALIZE Oral Solution contains 60 mg of nimodipine per 20 mL. In addition, the oral solution contains the following inactive ingredients: ethanol, glycerin, methylparaben, polyethylene glycol, sodium phosphate monobasic, sodium phosphate dibasic, and water.
Sources
Nymalize Manufacturers
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Arbor Pharmaceuticals
Nymalize | Arbor Pharmaceuticals
2.1 Administration InstructionsAdminister 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)].
2.2 Administration by Oral RouteThe recommended oral dosage is 20 mL (60 mg) every 4 hours for 21 consecutive days.
2.3 Administration Via Nasogastric or Gastric TubeUsing 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.
2.4 Dosage Adjustments in Patients with CirrhosisIn patients with cirrhosis, reduce the dosage to 10 mL (30 mg) every 4 hours [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].
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