Rx Item-Nymalize 60Mg 20Ml Solution 12 By Safecor Health

NYMALIZE- nimodipine solution
Arbor Pharmaceuticals

1 INDICATIONS AND USAGE

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).

2 DOSAGE AND ADMINISTRATION

2.1 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 (12.3)].

2.2 Administration by Oral Route


The recommended oral dosage is 20 mL (60 mg) every 4 hours for 21 consecutive days.

2.3 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.

2.4 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 (5.2) , Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Oral Solution (3 mg per mL):

60 mg per 20 mL, pale yellow solution
30 mg per 10 mL, pale yellow solution

RX ITEM-Nymalize 60Mg 20Ml Solution 12 B
NDC 24338-0200-12 UPC/GTIN No. Mfg.Part No.20012

Nymalize 60Mg 20Ml Solution 12 By Safeco
BRAND: NYMALIZE NDC: 24338-0200-12,24338020012 UPC: 3-24338-20012-4,324338200124

NIMODIPINE ORAL SOLUTION
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