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Nymalize: Uses, Dosage & Safety Information

Nymalize

Nymalize

Nymalize

Nimodipine
Nymalize is nimodipine oral solution for subarachnoid haemorrhage. Its 6 mg per mL strength is twice that of the generic 3 mg per mL solution, so the same 60 mg dose is 10 mL of one and 20 mL of the other, and the volumes are not interchangeable. Nymalize is a prescription-only medicine.
  • ActiveIngredient: Nimodipine
  • DosageForm: Oral solution
  • Dosage: 60 mg/10 mL, 30 mg/5 mL (6 mg/mL)
  • Indications: Subarachnoid haemorrhage from ruptured intracranial aneurysm
  • Manufacturer: Azurity Pharmaceuticals
  • Storage: Store at 20–25°C; do not refrigerate or freeze
  • Drug Status: Prescription Only
Drug Status: Prescription Only
Description

What is Nymalize?

The pharmacology of the drug, its trials and the boxed warning against injection are covered under nimodipine.

Millilitres are not interchangeable between the two products
Nymalize is twice as concentrated as the generic nimodipine oral solution, so the same dose fills half the volume; measuring by millilitres from the wrong product doubles or halves the dose.
Read across those figures: 10 mL is a full dose of Nymalize and a half dose of the generic; 20 mL is a full dose of the generic and a double dose of Nymalize. The safe unit of communication here is milligrams.12

Nymalize was approved under NDA 203340 as a ready-to-give liquid, supplied in unit-dose prefilled oral syringes, including syringes with the ENFit connector.1 The pharmacology of the drug itself, and the reason its route is the subject of a boxed warning, are covered under the molecule and its boxed warning.

General Instructions

How to Take Nymalize

Enterally only. By mouth, nasogastric tube or gastric tube. Never intravenously or by any other parenteral route.1

Check milligrams against millilitres before every dose. Two concentrations of nimodipine solution are on the market, and the volume that carries a full dose differs between them.

Give one hour before a meal or two hours after. Food lowers absorption of this drug substantially.

Through a tube, flush afterwards. Draw up the saline volume stated in the labelling into the supplied syringe and flush the remainder into the stomach, so the dose left coating the tube still reaches the patient.1

Every four hours for 21 days, starting within 96 hours of the haemorrhage.

Use only the supplied syringe. The oral syringe that comes with the product is marked for enteral use; never transfer the solution into a syringe that fits an intravenous line.1

If a dose is late. Ask the care team before giving it, because doses are scheduled every four hours around the clock.

Side Effects

What Are the Side Effects of Nymalize?

The safety of this oral solution rests on trials of nimodipine capsules, to which it has comparable bioavailability. The most common reactions, at 1% or more and above placebo, were low blood pressure, headache, nausea and slow heart rate.1

At the Labelled 60 mg Every 4 Hours
FrequencyEffect60 mg (n = 494)Placebo (n = 479)
CommonFall in blood pressure3.8%1.2%
CommonHeadache1.2%0.2%
CommonNausea1.2%0%
CommonSlow heart rate1.0%0%

Source: 1

Dosing Points That Affect Exposure
PointWhat the labelling says
Labelled volume10 mL (60 mg) every 4 hours for 21 days. By arithmetic, 20 mL would deliver 120 mg — twice the labelled dose
Tube administrationAfter giving the dose, refill the syringe with 10 mL of 0.9% saline and flush the remaining contents from the tube into the stomach
CirrhosisReduce to 5 mL (30 mg) every 4 hours

Source: 1

Seek immediate medical attention if:
  • Any amount has entered a vascular line — treat as an emergency regardless of volume
  • Blood pressure falls sharply after a dose
  • A dose has been given from the wrong concentration and the milligram amount is uncertain
Uses

What is Nymalize Used For?

Nymalize is approved to improve neurological outcome after subarachnoid haemorrhage from a ruptured intracranial aneurysm — the same indication as the capsules, in a presentation designed for patients who cannot reliably swallow one.

The labelling allows it to be given by mouth or through a nasogastric or gastric tube.1

What the presentation changes

The labelling directs administration only by an enteral route — by mouth, nasogastric tube or gastric tube — and specifies the tube procedure: give 10 mL from the supplied prefilled oral syringe, then refill the syringe with 10 mL of 0.9 per cent saline and flush the remaining contents through the tube into the stomach.1

Nothing in that sequence requires drawing liquid out of a capsule, and nothing produces a needle-compatible syringe on the ward. That is the whole purpose of the product.

▶Clinical detailstechnical detail

The ENFit connector is the engineering half of the same answer. It is a standardised enteral fitting whose thread and diameter are deliberately incompatible with intravenous luer connectors, so a syringe filled for a feeding tube cannot be attached to a vascular line by mistake.

This matters because the hazard being addressed is not ignorance. Staff in critical care know the drug is oral; the failure mode is a correctly prepared syringe that physically fits the wrong port during a busy handover. A connector that will not mate removes the possibility rather than warning against it.1

Safety Advice

Interactions Alcohol:

Consult your doctor
The labelling does not list an alcohol interaction; treatment is given in hospital after a brain haemorrhage.

Interactions Other Medications:

Unsafe
The most serious combination listed is with strong CYP3A4 inhibitors: clarithromycin, telithromycin, HIV protease inhibitors, azole antifungals including ketoconazole, nefazodone (contraindicated): nimodipine concentrations rise sharply. Every other combination, with its effect, is in the Interactions table.

Special Groups Pregnancy:

Consult your doctor
Discuss with the treating team; there are no adequate studies in pregnant women.

Special Groups Breastfeeding:

Consult your doctor
It is not known whether nimodipine passes into human milk; it appears in rat milk. The decision belongs to the treating team.

Special Groups Elderly:

Use with caution
No age-specific dose, but hypotension is the dose-limiting effect and is less well tolerated with age. Blood pressure is monitored throughout.

Special Groups Children:

Consult your doctor
Safety and effectiveness in children have not been established for this indication.

Effects on Activities Driving:

Consult your doctor
Not applicable during the treatment course, which follows a brain haemorrhage. Return to driving is a neurological decision.

Effects on Activities Operating Machinery:

Consult your doctor
The same applies — recovery from the haemorrhage is the limiting factor, not the medicine.
Warnings

Critical Warnings for Nymalize Use

Enteral administration only

Oral, nasogastric or gastric tube. Intravenous and other parenteral routes are prohibited.1

Two concentrations exist; orders in millilitres are unsafe

Nymalize is 6 mg per mL and the generic solution is 3 mg per mL. Prescriptions, handovers and administration records should state milligrams.

Reduce the dose in cirrhosis

Five millilitres (30 mg) every four hours rather than ten.1

Strong CYP3A4 inhibitors remain contraindicated

The interaction belongs to the molecule and is unchanged by the liquid form.

Do not give with food

One hour before or two hours after a meal, for absorption rather than tolerability.1

See Interactions for the full list.

Dosage

Dosage

Nimodipine Oral Solutions: Dose
ProductConcentrationVolume for 60 mgVolume for 30 mg
Nymalize, NDA 2033406 mg per mL10 mL5 mL
Nimodipine oral solution, ANDA 2169373 mg per mL20 mL10 mL

Source: 12

The same number of millilitres, two different doses
Ten millilitres is 60 mg of Nymalize and 30 mg of the generic solution. Twenty millilitres is 60 mg of the generic and 120 mg of Nymalize — twice the approved dose, at which hypotension roughly doubled in the capsule trials.
Dosing and Adjustments
SituationNymalize dose
Standard10 mL (60 mg) at 4-hour intervals for 21 consecutive days
Cirrhosis5 mL (30 mg) at 4-hour intervals
Start windowWithin 96 hours of the subarachnoid haemorrhage
Any parenteral routeNot permitted at any dose
Renal impairment—No labelled dose adjustment; elimination is predominantly hepatic

Source: 1

Interactions

What Does Nymalize Interact With?

Interacting Substances
Interacting substanceEffect and riskSeverityDocumentation
Strong CYP3A4 inhibitors: clarithromycin, telithromycin, HIV protease inhibitors, azole antifungals including ketoconazole, nefazodoneNimodipine concentrations rise sharply; hypotensionContraindicatedExcellent — labelled contraindication
Strong CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, phenobarbitalConcentrations fall; efficacy may be lostMajorGood — labelled warning
Other antihypertensive agentsAdditive lowering of blood pressureMajorGood — labelled precaution
Food taken with the doseReduced absorptionModerateExcellent — basis of the labelled timing instruction

Source: 1

Two of these rows point in opposite directions: inhibitors raise exposure enough to be forbidden, inducers lower it enough to threaten the reason for treating at all.

FAQs
Same drug, different concentration. Nymalize is 6 mg per mL; the generic solution is 3 mg per mL. A 60 mg dose is 10 mL of one and 20 mL of the other.
Because doses get communicated in millilitres. Ten millilitres is a full dose of Nymalize and half a dose of the generic; twenty millilitres is a full dose of the generic and double the approved dose of Nymalize.
The capsule labelling describes piercing the capsule, drawing out the liquid and transferring it to an oral syringe that cannot accept a needle, labelled not for IV use. Nymalize supplies the drug as a ready-to-give liquid in prefilled oral syringes instead.
Yes. The labelling lists 30 mg per 5 mL and 60 mg per 10 mL unit-dose prefilled syringes, including versions with an ENFit enteral connector.
Ten millilitres from the supplied prefilled oral syringe, then the syringe is refilled with 10 mL of 0.9 per cent saline and the remaining drug flushed through the tube into the stomach.
Evidence and Reported Data

Evidence Scope

What we know
  • Nymalize is 6 mg per mL, supplied as 60 mg in 10 mL and 30 mg in 5 mL in unit-dose prefilled oral syringes, including ENFit syringes.1
  • A separate nimodipine oral solution is marketed at 3 mg per mL, delivering 60 mg in 20 mL.2
  • Administration is enteral only; the tube procedure includes a 10 mL saline flush after the dose.1
  • Cirrhosis requires 5 mL (30 mg) every four hours instead of 10 mL.1
What remains uncertain
  • Whether the solution and the capsules perform identically in the sickest patients. The approval rests on pharmacokinetic comparison rather than on a fresh outcome trial in subarachnoid haemorrhage, so outcome equivalence is inferred from exposure rather than measured directly.
  • Postmarketing limits. Spontaneous reports can flag potential problems but cannot establish how often they occur; there is no denominator and reporting is voluntary.

Who was this medicine studied in?

No FDA Drug Trials Snapshot exists for this product. Snapshots cover new molecular entities at original approval, and Nymalize is a new presentation of a molecule approved decades earlier. The clinical evidence for benefit after subarachnoid haemorrhage comes from the capsule programme described on the molecule page.3

Who this is and is not appropriate for

Typically considered for: adults being treated after aneurysmal subarachnoid haemorrhage who cannot reliably swallow capsules, including those fed by nasogastric or gastric tube, where a measured liquid and an enteral-only connector remove a preparation step.

Not appropriate for: administration by any parenteral route; patients taking a contraindicated strong CYP3A4 inhibitor; any situation where the prescribed dose has been communicated in millilitres without the milligram amount, until that is clarified. In cirrhosis the volume is halved rather than the product avoided.1

Product listings and approval status are taken from FDA databases.5

Concentrations and Volumes

Nymalize once also came as a 3 mg per mL solution; that strength is recorded as discontinued, with a Federal Register determination that it was not withdrawn for safety or effectiveness reasons. The current Nymalize strength is 6 mg per mL, and generic nimodipine oral solution is 3 mg per mL, the reference standard for that concentration.4

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA Prescribing Information, NYMALIZE (nimodipine) oral solution, NDA 203340 — Sections 2.1–2.4 Dosage and Administration, 3 Dosage Forms and Strengths, 4 Contraindications, 5 Warnings and Precautions, 7 Drug Interactions, 11 Description, 16 How Supplied
    Label revised 2024-08 · Accessed 2026-09-24
    Used for: the 6 mg per mL concentration and the 60 mg / 10 mL and 30 mg / 5 mL presentations; the unit-dose prefilled and ENFit syringes; the enteral-only administration instruction; the nasogastric and gastric tube procedure with the 10 mL saline flush; the 96-hour start window and 21-day course; the cirrhosis dose reduction; the contraindicated CYP3A4 inhibitors and the inducer warning.
    dailymed.nlm.nih.gov — NYMALIZE SPL
  2. FDA Prescribing Information, nimodipine oral solution 3 mg/mL, ANDA 216937 — Section 3 Dosage Forms and Strengths and Section 2 Dosage and Administration
    Accessed 2026-09-24
    Used for: the existence of a second marketed concentration at 3 mg per mL delivering 60 mg in 20 mL, which is the basis for the volume comparison on this page.
    dailymed.nlm.nih.gov
  3. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-24
    Used for: the basis for stating that no Snapshot exists: the programme covers new molecular entities at original approval, which a reformulation is not.
    fda.gov — Drug Trials Snapshots
  4. Drugs@FDA — application records NDA 203340 (Nymalize) and ANDA 216937 (nimodipine oral solution)
    Records accessed 2026-09-27
    Used for: the discontinued 3 mg/mL Nymalize strength and its Federal Register determination, the current 6 mg/mL strength, and the reference-standard generic 3 mg/mL solution.
    accessdata.fda.gov — Drugs@FDA
  5. FDA Orange Book — Nymalize
    Current edition · Accessed 2026-10-02
    Used for: reference-standard and generic availability.
    accessdata.fda.gov — Orange Book

How this page was sourced

Both labellings are cited because the page is a comparison between two marketed concentrations, and a reader should be able to check each figure against its own document.

Nothing is claimed about how often volume confusion occurs. The page states the arithmetic and leaves the frequency where the evidence leaves it — unmeasured.

FAERS aggregates are not included here. Under §4.13 the block belongs on the page representing the active ingredient. Reports are retrieved by ingredient and cover every nimodipine formulation, capsules and oral solution alike containing it, so they are shown on the nimodipine page rather than attached to this brand.

Review cycle. Clinical review completed 2 October 2026. Next review due by 2 October 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.