"July 25, 2014 -- When the blood-thinner drug Pradaxa (dabigatran) was FDA-approved in 2010 to prevent stroke in people at high risk, a major selling point was that it doesn't require frequent blood tests like the old standby drug, warfarin.
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
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
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.
Additional Nymalize Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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