Brand Name
Nymalize
Generic Name
NiMODipine
View Brand Information FDA approval date: November 07, 2017
Classification: Dihydropyridine Calcium Channel Blocker
Form: Capsule, Solution
What is Nymalize (NiMODipine)?
Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition .
Approved To Treat
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Brand Information
Nymalize (nimodipine)
1INDICATIONS 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).
2DOSAGE FORMS AND STRENGTHS
Oral Solution (6 mg per mL):
- 60 mg per 10 mL, pale yellow solution in unit-dose prefilled syringe
- 30 mg per 5 mL, pale yellow solution in unit-dose prefilled syringe
- 30 mg per 5 mL, pale yellow solution in unit-dose prefilled ENFit
- 60 mg per 10 mL (6 mg/mL), pale yellow solution in 8 oz bottle
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The safety and efficacy of NYMALIZE (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH. NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules.
The following clinically significant adverse reaction appears in other sections of the labeling:
- Hypotension
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical trials of nimodipine oral capsules in patients with SAH, eleven percent (92 of 823) of nimodipine-treated patients reported adverse events compared to six percent (29 of 479) of placebo-treated patients. The most common adverse event was decreased blood pressure in 4.4% of nimodipine-treated patients. The events reported with a frequency greater than 1% are displayed in Table 1 by dose.
SAH is frequently accompanied by alterations in consciousness that may lead to an under-reporting of adverse experiences. As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed in SAH trials.
5OVERDOSAGE
There have been no reports of overdosage from the oral administration of nimodipine. Symptoms of overdosage would be expected to be related to cardiovascular effects such as excessive peripheral vasodilation with marked systemic hypotension. Clinically significant hypotension due to nimodipine overdosage may require active cardiovascular support with pressor agents and specific treatments for calcium channel blocker overdose. Since nimodipine is highly protein-bound, dialysis is not likely to be of benefit.
6DESCRIPTION
NYMALIZE contains nimodipine, a dihydropyridine calcium channel blocker. Nimodipine is isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(
Nimodipine is a yellow crystalline substance, practically insoluble in water.
NYMALIZE Oral Solution contains 60 mg of nimodipine per 10 mL. In addition, the oral solution contains the following inactive ingredients: ethanol, glycerin, methylparaben, polyethylene glycol 400.
7CLINICAL STUDIES
The safety and efficacy of NYMALIZE (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH. NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules.
Nimodipine has been shown in 4 randomized, double-blind, placebo-controlled trials to reduce the severity of neurological deficits resulting from vasospasm in patients who have had a recent SAH (Studies 1, 2, 3, and 4).
The trials used doses ranging from 20-30 mg to 90 mg every 4 hours, with drug given for 21 days in 3 studies, and for at least 18 days in the other. Three of the four trials followed patients for 3-6 months. Three of the trials studied relatively well patients, with all or most patients in Hunt and Hess Grades I - III (essentially free of focal deficits after the initial bleed). Study 4 studied much sicker patients with Hunt and Hess Grades III - V. Studies 1 and 2 were similar in design, with relatively unimpaired SAH patients randomized to nimodipine or placebo. In each, a judgment was made as to whether any late-developing deficit was due to spasm or other causes, and the deficits were graded. Both studies showed significantly fewer severe deficits due to spasm in the nimodipine group; Study 2 showed fewer spasm-related deficits of all severities. No effect was seen on deficits not related to spasm. See
Study 3 was a 554-patient trial that included SAH patients with all grades of severity (89% were in Hunt and Hess Grades I-III). In Study 3, patients were treated with placebo or 60 mg of nimodipine every 4 hours. Outcomes were not defined as spasm related or not but there was a significant reduction in the overall rate of brain infarction and severely disabling neurological outcome at 3 months (Table 3):
Study 4 enrolled much sicker patients, (Hunt and Hess Grades III-V), who had a high rate of death and disability, and used a dose of 90 mg every 4 hours, but was otherwise similar to Study 1 and Study 2. Analysis of delayed ischemic deficits, many of which result from spasm, showed a significant reduction in spasm-related deficits. Among analyzed patients (72 nimodipine, 82 placebo), there were the following outcomes (Table 4).
When data were combined for Study 3 and Study 4, the treatment difference on success rate (i.e., good recovery) on the Glasgow Outcome Scale was 25.3% (nimodipine) versus 10.9% (placebo) for Hunt and Hess Grades IV or V. Table 5 demonstrates that nimodipine tends to improve good recovery of SAH patients with poor neurological status post-ictus, while decreasing the numbers with severe disability and vegetative survival.
A dose-ranging study comparing 30 mg, 60 mg, and 90 mg doses found a generally low rate of spasm-related neurological deficits but no dose response relationship.
8HOW SUPPLIED/STORAGE AND HANDLING
NYMALIZE (nimodipine) Oral Solution 6 mg/mL is a pale yellow solution and is supplied as follows:
- NDC 24338-260-08: 8 oz. bottle (237 mL) 60 mg/10 mL (6 mg/mL)
- NDC 24338-260-12: Carton containing 12 individually wrapped 10 mL packages.
- NDC 24338-230-12: Carton containing 12 individually wrapped 5 mL packages.
- NDC 24338-230-30: Carton containing 12 blisters.
9PATIENT COUNSELING INFORMATION
Inform patients that the most frequent adverse reaction associated with nimodipine is decreased blood pressure [
Patients should be aware that ingestion of grapefruit or grapefruit juice should be avoided when taking NYMALIZE due to its ability to increase nimodipine plasma concentrations and potential to increase the risk of hypotension
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant during therapy
Advise female patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant
10PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label
Mfg. for Azurity Pharmaceuticals, Inc.
NDC 2433826010
Store at controlled
Nymalize
60 mg/10 mL
For Oral Use Only
Rev. 05/22
11PRINCIPAL DISPLAY PANEL - 10 mL Syringe Package
10 mL
Nymalize
60 mg / 10 mL
For Oral Use Only
Recommended Dosage:
Keep out of reach of children
Store between 20°C to 25°C (68°F - 77°F);
NDC: 24338-260-10
One 10 mL Unit-Dose Oral Syringe
Rx Only
EXP: 2023-05-31
Mfg For Azurity Pharmaceuticals, Inc. Woburn, MA 01801
NYM-OW10-S01
12PRINCIPAL DISPLAY PANEL - 10 mL Syringe Package Carton
NDC: 24338-260-12
Nymalize
60 mg/10 mL
Contains 12 Prefilled
For Oral Use Only
Distributed by:
13PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
Mfg. for Azurity Pharmaceuticals, Inc.
NDC 2433823005
Store at controlled
Nymalize
30 mg/5 mL
For Oral Use Only
Rev. 05/22
14PRINCIPAL DISPLAY PANEL - 5 mL Syringe Package
5 mL
Nymalize
30 mg / 5 mL
For Oral Use Only
Recommended Dosage:
Keep out of reach of children
Store between 20°C to 25°C (68°F - 77°F);
NDC: 24338-230-05
One 5 mL Unit-Dose Oral Syringe
Rx Only
EXP: 2023-04-30
Mfg For Azurity Pharmaceuticals, Inc. Woburn, MA 01801
NYM-OW05-S01
15PRINCIPAL DISPLAY PANEL - 5 mL Syringe Package Carton
NDC: 24338-230-12
Nymalize
30 mg/5 mL
Contains 12 Prefilled
For Oral Use Only
Distributed by:
16PRINCIPAL DISPLAY PANEL - 5 mL ENFit® Syringe Label
NDC 24338-230-15
Rx Only
Nymalize®
30 mg/5 mL
ENFit
For Oral Use Only
17PRINCIPAL DISPLAY PANEL - 5 mL ENFit® Syringe Blister Label
NDC 24338-230-15
Rx Only
Nymalize®
30 mg/5 mL ENFit
One 5 mL ENFit
For Oral Use Only
Store between 20°C to 25°C (68°F - 77°F); excursions permitted to 15°C to 30°C (59°F- 86°F).
Manufactured for:
azurity
Woburn, MA 01801
18PRINCIPAL DISPLAY PANEL - 5 mL ENFit® Syringe Carton Label
NDC 24338-230-30
Rx Only
Nymalize®
30 mg/5 mL ENFit® Syringe
Contains 12 Prefilled ENFit
For Oral Use Only
Recommended Dosage: See prescribing information.
Keep out of reach of children.
Package not child resistant.
Store between 20°C to 25°C (68°F - 77°F); excursions permitted to 15°C to 30°C (59°F- 86°F).
Manufactured for:
azurity® Pharmaceuticals
Woburn, MA 01801
