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Nymalize

"On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was av"...

Nymalize

INDICATIONS

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).

DOSAGE AND ADMINISTRATION

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].

Administration by Oral Route

The recommended oral dosage is 20 mL (60 mg) every 4 hours 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, CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Oral Solution: 60 mg per 20 mL (3 mg/mL), pale yellow solution

Storage And Handling

NDC 24338-200-16: 16 oz. bottle (473 mL)

NDC 24338-200-12: Carton containing 12 individually wrapped packages. Each package contains one 20 mL Unit-Dose cup (NDC 24338-200-20) and one oral syringe.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Protect from light.

Do not refrigerate.

Manufactured for: Atlanta, GA 30328. Manufactured by: Importfab, Pointe-Claire, QC, Canada H9R 1C9. Distributed By Arbor Pharmaceuticals, Inc., Atlanta, GA 30328. Revised: May 2013

Last reviewed on RxList: 5/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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