(nye MOE di peen)
Subarachnoid hemorrhage: 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 postictus neurological condition (ie, Hunt and Hess grades I to V)
US labeling:
Concomitant use with strong CYP3A4 inhibitors (eg, clarithromycin, telithromycin, delaviridine, indinavir, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, voriconazole, and nefazodone).
Nymalize: There are no contraindications listed in the manufacturer 's labeling.
Canadian labeling: Hypersensitivity to nimodipine or any component of the formulation; concomitant use with phenobarbital, phenytoin, carbamazepine, or rifampin
Do not administer nimodipine intravenously (IV) or by other parenteral routes. Deaths and serious, life-threatening adverse reactions have occurred when the contents of nimodipine capsules have been injected parenterally.
Note: For oral administration ONLY.
Subarachnoid hemorrhage: Oral: 60 mg every 4 hours for 21 consecutive days. Note: Start therapy within 96 hours of the onset of subarachnoid hemorrhage.
Refer to adult dosing.
No dosage adjustment provided in manufacturer 's labeling. However, nimodipine undergoes minimal renal elimination and dose adjustment may not be necessary. Not removed by hemo- or peritoneal dialysis; supplemental dose is not necessary.
Reduce dosage to 30 mg every 4 hours in patients with cirrhosis.
For enteral administration ONLY. Life-threatening adverse events have occurred when administered parenterally. Administer on an empty stomach at least 1 hour before or 2 hours after meals.
Oral:
US labeling: Administer on an empty stomach at least 1 hour before or 2 hours after meals.
Canadian labeling: Administer without regards to meals; but administer consistently with or without meals. Tablet should be swallowed whole with an adequate amount of fluid (eg, glass of water). Do not crush tablet. Avoid alkaline mixtures for 2 hours before or after administration. Patient should not be lying down during administration.
Nasogastric (NG) or gastric tube administration:
Oral solution (Nymalize): Administer using the supplied oral syringe labeled ORAL USE ONLY". Following administration, refill the oral syringe with 20 mL of NS and flush any remaining contents from NG or gastric tube into the stomach.
Capsules: If the capsules cannot be swallowed, the liquid may be removed by making a hole in each end of the capsule with an 18-gauge needle and extracting the contents into a syringe; transfer these contents into an oral syringe (amber-colored oral syringe preferred). It is strongly recommended that preparation be done in the pharmacy. Label oral syringe with WARNING: For ORAL use only " � or "Not for IV use. " � Follow with a flush of 30 mL NS.
Store at 25 � �C (77 � �F); excursions are permitted to 15 � �C to 30 � �C (59 � �F to 86 � �F). Protect capsules from light and freezing. Protect solution from light and do not refrigerate.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Generic: 30 mg
Solution, Oral:
Nymalize: 60 mg/20 mL (20 mL, 473 mL) [contains alcohol, usp, methylparaben, polyethylene glycol]
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification
Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy
Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy
Barbiturates: May increase the metabolism of Calcium Channel Blockers. Management: Monitor for decreased therapeutic effects of calcium channel blockers with concomitant barbiturate therapy. Calcium channel blocker dose adjustments may be necessary. Nimodipine Canadian labeling contraindicates concomitant use with phenobarbital. Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Calcium Channel Blockers (Nondihydropyridine): Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Calcium Channel Blockers (Nondihydropyridine). Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Monitor therapy
Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Monitor therapy
Cimetidine: May increase the serum concentration of Calcium Channel Blockers. Management: Consider alternatives to cimetidine. If no suitable alternative exists, monitor for increased effects of calcium channel blockers following cimetidine initiation/dose increase, and decreased effects following cimetidine discontinuation/dose decrease. Consider therapy modification
Clopidogrel: Calcium Channel Blockers may diminish the therapeutic effect of Clopidogrel. Monitor therapy
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination
CycloSPORINE (Systemic): May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of NiMODipine. Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of NiMODipine. Avoid combination
CYP3A4 Inducers (Weak): May decrease the serum concentration of NiMODipine. Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of NiMODipine. Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of NiMODipine. Avoid combination
CYP3A4 Inhibitors (Weak): May increase the serum concentration of NiMODipine. Monitor therapy
Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification
Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Monitor therapy
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy
Efavirenz: May decrease the serum concentration of Calcium Channel Blockers. Monitor therapy
Fluconazole: May increase the serum concentration of Calcium Channel Blockers. Monitor therapy
FLUoxetine: May increase the serum concentration of NiMODipine. Monitor therapy
Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination
Grapefruit Juice: May increase the serum concentration of NiMODipine. Avoid combination
Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy
Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy
Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy
Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Macrolide Antibiotics: May decrease the metabolism of Calcium Channel Blockers. Management: Consider using a noninteracting macrolide. Felodipine Canadian labeling specifically recommends avoiding its use in combination with clarithromycin. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. Consider therapy modification
Magnesium Salts: Calcium Channel Blockers may enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Monitor therapy
Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine). Monitor therapy
Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nafcillin: May increase the metabolism of Calcium Channel Blockers. Consider therapy modification
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification
Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
QuiNIDine: Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of QuiNIDine. Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of QuiNIDine. QuiNIDine may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Monitor therapy
Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
St Johns Wort: May decrease the serum concentration of NiMODipine. Avoid combination
Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification
Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy
1% to 10%:
Cardiovascular: Decreased blood pressure (4% to 5%), bradycardia (1%)
Central nervous system: Headache (1%)
Gastrointestinal: Nausea (1%)
<1% (Limited to important or life-threatening): Anemia, decreased platelet count, disseminated intravascular coagulation, edema, gastrointestinal hemorrhage, gastrointestinal pseudo-obstruction, hematoma, hepatitis, hypertension, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum ALT, increased serum glucose, intestinal obstruction, jaundice, rebound vasospasm, thrombocytopenia
In patients with cirrhosis, bioavailability is increased and Cmax almost doubles; dosage adjustment is recommended.
AUC and Cmax were approximately twofold higher in elderly patients as compared to younger patients; this response is not considered clinically significant.
Concerns related to adverse effects:
- Angina/MI: Increased angina and/or MI have occurred with initiation or dosage titration of dihydropyridine calcium channel blockers. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.
- Gastrointestinal events: Intestinal pseudo-obstruction and ileus have been reported (rarely) during therapy.
- Hypotension/syncope: Symptomatic hypotension with or without syncope can occur; blood pressure must be lowered at a rate appropriate for the patients clinical condition. Monitor blood pressure closely during treatment.
- Peripheral edema: Peripheral edema is a common adverse event; occurs within 2-3 weeks of starting therapy.
Disease-related concerns:
- Hepatic impairment: Use with caution in patients with cirrhosis due to the increased plasma concentrations of nimodipine and an increased risk of adverse reactions; a lower dose and close monitoring of blood pressure and heart rate are required.
- Hypertrophic cardiomyopathy with outflow tract obstruction: Use with caution in patients with hypertrophic cardiomyopathy with outflow tract obstruction.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Other warnings/precautions:
- Inadvertent IV administration: [U.S. Boxed Warning]: Nimodipine has inadvertently been administered IV when withdrawn from capsules into a syringe for subsequent nasogastric administration. Severe cardiovascular adverse events, including fatalities, have resulted; precautions (eg, adequate labeling, use of oral syringes) should be employed against such an event.
C
Adverse events have been observed in animal reproduction studies. Nimodipine crosses the placenta (Belfort, 1994). Nimodipine has been evaluated for the management of pre-eclampsia (Belfort, 1994; Belfort, 2003), but it is not one of the agents currently recommended for severe intrapartum or postpartum hypertension associated with preeclampsia or eclampsia (ACOG, 2015).
Nimodipine shares the pharmacology of other calcium channel blockers; animal studies indicate that nimodipine has a greater effect on cerebral arterials than other arterials; this increased specificity may be due to the drugs increased lipophilicity and cerebral distribution as compared to nifedipine; inhibits calcium ion from entering the "slow channels " � or select voltage sensitive areas of vascular smooth muscle and myocardium during depolarization
Extensively hepatic via CYP3A4; undergoes first-pass metabolism
Urine (<1% as unchanged drug); feces
Serum: ~1 hour
1 to 2 hours; prolonged with renal impairment
>95%
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber severe dizziness or syncope (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.