Nimodipine

What is Nimodipine?

• Nimodipine (NYMALIZE) is a dihydropyridine calcium channel blocker used in the treatment of cerebral vasospasm after subarachnoid hemorrhage.

What are the uses of this medicine?

• This medicine is used 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).

How does this medicine work?

• Nimodipine (nye moe' di preen) belongs to the dihydropyridine class of calcium channel blockers (similar to amlopidine and felodipine) and is used to treat cerebral vasospasm after subarachnoid hemorrhage.
• Like other calcium channel blockers, nimodipine acts by inhibition of the influx of calcium ions into smooth muscle cells during depolarization which results in vasodilation.
• Nimodipine has high lipid solubility and was developed specifically to treat cerebral vasospasm.
• Clinical trials have suggested that nimodipine reduces infarct size and complications after subarachnoid hemorrhage.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Coadministration with anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa may increase risk of hypotension. Monitor blood pressure.
• Nimodipine plasma concentration can be significantly increased when concomitantly administered with strong CYP3A4 inhibitors strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) .
• Nimodipine plasma concentration can also be increased in the presence of moderate and weak inhibitors of CYP3A4 (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil).
• Grapefruit juice inhibits CYP3A4. Ingestion of grapefruit/grapefruit juice is not recommended while taking nimodipine.
• Concomitant use of NYMALIZE with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort) should generally be avoided.
• Moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: Administration by Oral Route

• The recommended oral dosage is 20 mL (60 mg) every 4 hours for 21 consecutive days.

Administration Via Nasogastric or Gastric Tube

• Using the supplied oral syringe labeled "ORAL USE ONLY", administer 20 mL (60 mg) every 4 hours into a nasogastric or gastric tube for 21 consecutive days. For each dose, refill the syringe with 20 mL of 0.9% saline solution and then flush any remaining contents from nasogastric or gastric tube into the stomach.

Dosage Adjustments in Patients with Cirrhosis

• In patients with cirrhosis, reduce the dosage to 10 mL (30 mg) every 4 hours

Administration

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Oral solution (3 mg per mL):

• 60 mg per 20 mL
• 30 mg per 10 mL

This medicine is available in fallowing brand namesː

• NYMALIZE

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypotension
• headache
• nausea
• bradycardia

What special precautions should I follow?

• Blood pressure should be carefully monitored during treatment with NYMALIZE.
• Given that the plasma levels of nimodipine are increased in patients with cirrhosis, these patients are at higher risk of adverse reactions. Therefore, monitor blood pressure and pulse rate closely and administer a lower dosage .
• Concomitant use of strong inhibitors of CYP3A4 with nimodipine should generally be avoided because of a risk of significant hypotension.
• Concomitant use of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort) and nimodipine should generally be avoided.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Symptoms of overdosage would be expected to be related to cardiovascular effects such as excessive peripheral vasodilation with marked systemic hypotension.

Management of Overdose

• 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.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of NYMALIZE in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• nimodipine

Inactive ingredients:

• alcohol
• glycerin
• methylparaben
• polyethylene glycol 400
• sodium phosphate, monobasic, unspecified form
• sodium phosphate, dibasic, unspecified form
• water

Who manufactures and distributes this medicine?

Manufactured for: Arbor Pharmaceuticals, LLC Atlanta

Manufactured by: Importfab Pointe-Claire, QC, Canada

• Distributed by Arbor Pharmaceuticals, LLC, Atlanta

What should I know about storage and disposal of this medication?

• Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
• Protect from light.
• Do not refrigerate.

• Dailymed label info on Nimodipine
• FDA Nimodipine

Antihypertensive agents

• Dailymed label info on Nimodipine
• FDA Nimodipine