Dosing & Uses
Dosage Forms & Strengths
oral solution (Nymalize)
Indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their postictus neurological condition (ie, Hunt and Hess Grades I-V)
60 mg PO q4hr for 21 days; begin therapy within 96 hours of subarachnoid hemorrhage
Renal impairment: Supplemental dose not necessary in hemodialysis or peritoneal dialysis
Hepatic impairment: Decrease dose to 30 mg PO q4hr; closely monitor BP and HR
Subarachnoid Hemorrhage (Orphan)
New dosage form
Orphan designation for intraventricular injection for treatment of subarachnoid hemorrhage
- Edge Therapeutics, Inc; 211 Warren Street, Newark, NJ 07103
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Reduction in systemic blood pressure (1-8%)
Abdominal discomfort (2%)
Black Box Warnings
Do not administer contents of gel capsule or oral solution IV or by other parenteral routes
Deaths and serious life-threatening adverse events (ie, significant hypotension requiring pressor support) have occurred when injected parenterally
Parenteral administration; risk of death (see Black Box Warnings)
Congestive heart failure
Reflex tachycardia resulting in angina and/or MI in patients with obstructive coronary disease reported
Metabolism decreased in patients with hepatic impairment
Use caution in hepatic impairment or hypertrophic subaortic stenosis
Peripheral edema may occur within 2-3 weeks of initiating therapy
Hypotension with or without syncope is possible (particularly with severe aortic stenosis)
Intestinal pseudo-obstruction and ileus have been reported rarely
A decreased dose may be required with strong CYP3A4 inhibitors
Pregnancy & Lactation
Pregnancy Category: C
Lactation: unknown; avoid
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Ca channel blocker with minimal effects on conduction in heart; primary effect is upon cerebral arteries to prevent vasospasm
Highly lipophilic, allowing it to cross the blood-brain barrier
Peak Plasma Time: 1 hr
Peak Plasma Concentration: 80 ng/mL
Protein Bound: 95%
Vd: 0.43 L/kg
Hepatic P450 enzyme CYP3A4
Half-Life: 1-2 hr
Total Body Clearance: 0.84 L/kg (healthy); 1.18 L/kg (SAH)
Excretion: Urine (50%); feces (32%)
Gel capsule: Swallow capsule whole; if unable to swallow, may withdraw liquid content out with syringe and administer PO
Oral solution: Administer only enterally (eg, oral, nasogastric tube, or gastric tube route); for each dose, refill the syringe with 20 mL of 0.9% NaCl and then flush any remaining contents from NG or gastric tube into the stomach
Do not administer gel capsule contents or oral solution IV or any other parenteral route (see Black Box Warnings)
Take at least 1 hr before or 2 hr after meals
Avoid grapefruit juice
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