Matching articles for "Nymalize"
In Brief: Nimodipine Oral Solution (Nymalize)
The Medical Letter on Drugs and Therapeutics • August 19, 2013; (Issue 1423)
The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after subarachnoid hemorrhage...
The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after subarachnoid hemorrhage from a ruptured intracranial aneurysm. An older formulation of nimodipine has been available for such use for many years.1
Since 1988, nimodipine has been available only in liquid-filled gel capsules (Nimotop, and generics) that a conscious patient could swallow intact. For unconscious patients, the package insert included instructions for use of a needle and syringe to aspirate the liquid from the capsules and inject it into a feeding tube. However, some healthcare providers mistakenly injected the nimodipine liquid into IV tubing instead; IV nimodipine can cause severe hypotension, cardiac arrest and death. In 2006, the FDA added a boxed warning to the labeling regarding the dangers of giving oral nimodipine intravenously, but errors continued to occur. In 2010, the FDA warned again that nimodipine should only be administered orally or through a nasogastric or gastric feeding tube.2
Nymalize, a 60 mg/20 mL solution, can be administered orally or through a nasogastric or gastric feeding tube. Use of the oral syringe supplied with the drug for administration through a feeding tube should prevent erroneous IV injection. No new clinical trials were required for approval of Nymalize.
1. Nimodipine for cerebral vasospasm after subarachnoid hemorrhage. Med Lett Drugs Ther 1989; 31:47.
2. FDA Drug Safety Communication: serious medication errors from intravenous administration of nimodipine oral capsules. Available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220386.htm. Accessed August 6, 2013.
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Since 1988, nimodipine has been available only in liquid-filled gel capsules (Nimotop, and generics) that a conscious patient could swallow intact. For unconscious patients, the package insert included instructions for use of a needle and syringe to aspirate the liquid from the capsules and inject it into a feeding tube. However, some healthcare providers mistakenly injected the nimodipine liquid into IV tubing instead; IV nimodipine can cause severe hypotension, cardiac arrest and death. In 2006, the FDA added a boxed warning to the labeling regarding the dangers of giving oral nimodipine intravenously, but errors continued to occur. In 2010, the FDA warned again that nimodipine should only be administered orally or through a nasogastric or gastric feeding tube.2
Nymalize, a 60 mg/20 mL solution, can be administered orally or through a nasogastric or gastric feeding tube. Use of the oral syringe supplied with the drug for administration through a feeding tube should prevent erroneous IV injection. No new clinical trials were required for approval of Nymalize.
1. Nimodipine for cerebral vasospasm after subarachnoid hemorrhage. Med Lett Drugs Ther 1989; 31:47.
2. FDA Drug Safety Communication: serious medication errors from intravenous administration of nimodipine oral capsules. Available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220386.htm. Accessed August 6, 2013.
Download complete U.S. English article