Nymalize 30 mg/5mL
nimodipine · SOLUTION · Azurity Pharmaceuticals, Inc.
Nymalize is a solution containing nimodipine at 30 mg/5mL, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Nymalize
- Generic Name
- nimodipine
- NDC Code (Product)
24338-230- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Strength
- 30 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA203340
- Drug Class
- Dihydropyridine Calcium Channel Blocker [EPC]
- Marketing Start
- 05/04/2020
Recall History
Arbor Pharmaceuticals Inc.
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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). NYMALIZE is a dihydropyridine calcium channel blocker 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). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes. ( 2.1 ) Give one hour before a meal or two hours after a meal. ( 2.1 ) Start dosing within 96 hours of the SAH. ( 2.1 ) Recommended dose is 10 mL (60 mg) every 4 hours for 21 consecutive days. ( 2.2 ) Nasogastric or Gastric Tube Administration: Administer 10 mL (60 mg) every 4 hours with supplied prefilled oral syringe. Refill syringe with 10 mL of 0.9% saline water solution; flush remaining contents from nasogastric or gastric tube into stomach. ( 2.3 ) Patients with Cirrhosis: Reduce dosage to 5 mL (30 mg) every 4 hours. ( 2.4 ) 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 10 mL (60 mg) every 4 hours for 21…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Anti-Hypertensives : May increase risk of hypotension. Monitor blood pressure. ( 7.1 ) CYP3A4 Moderate and Weak Inhibitors: May increase risk of hypotension. Monitor blood pressure. Dose reduction of NYMALIZE may be needed. Avoid grapefruit juice. ( 7.2 ) CYP3A4 Moderate and Weak Inducers: May reduce efficacy of NYMALIZE. Dose increase may be needed. ( 7.3 ) 7.1 Blood Pressure Lowering Drugs Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa. In Europe, nimodipine was observed to occasionally intensify the effect of antihypertensive drugs taken concomitantly by hypertensive patients; this phenomenon was not observed in North American clinical trials. Blood pressure should be carefully monitored, and dose adjustment of the blood pressure lowering drug(s) may be necessary. 7.2 CYP3A4 Inhibitors Nimodipine plasma concentration can be significantly increased when concomitantly administered with strong CYP3A4 inhibitors. As a consequence, the b…
Adverse Reactions
6 ADVERSE 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 [see Warnings and Precautions (5.1) ]. Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 s…
Frequently Asked Questions
What is Nymalize used for?
Nymalize contains nimodipine. It is a solution taken oral. Consult your doctor for specific uses.
Is Nymalize a controlled substance?
Nymalize is not classified as a controlled substance by the DEA.
What is the generic name for Nymalize?
The generic name for Nymalize is nimodipine. There are 3 other brand versions of nimodipine.
What is the NDC code for Nymalize 30 mg/5mL?
The NDC (National Drug Code) for Nymalize 30 mg/5mL is 24338-230, listed by Azurity Pharmaceuticals, Inc..