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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:
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 nimodipinetreated 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.
Table 1: Adverse Events [n (%)] reported with a
frequency > 1% in four clinical trials (Study 1, Study 2, Study 3, and Study 4)
|Nimodipine dose every 4 hours|
|Decreased Blood Pressure||6 (1.2)||1 (1.2)||0||19 (3.8)||14 (8.1)||2 (50.0)|
|Edema||3 (0.6)||0||0||2 (0.4)||2 (1.2)||0|
|Diarrhea||3 (0.6)||0||3 (4.2)||0||3 (1.7)||0|
|Rash||3 (0.6)||2 (2.4)||0||3 (0.6)||2 (1.2)||0|
|Headache||1 (0.2)||0||1 (1.4)||6 (1.2)||0||0|
|Gastrointestinal Symptoms||0||2 (2.4)||0||0||2 (1.2)||0|
|Nausea||0||1 (1.2)||1 (1.4)||6 (1.2)||1 (0.6)||0|
|EKG Abnormalities||0||0||1 (1.4)||0||1 (0.6)||0|
|Bradycardia||0||0||0||5 (1.0)||1 (0.6)||0|
|Muscle Pain/Cramp||0||0||1 (1.4)||1 (0.2)||1 (0.6)||0|
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.
Read the Nymalize (nimodipine oral solution) Side Effects Center for a complete guide to possible side effects
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.
Nimodipine plasma concentration can be significantly increased when concomitantly administered with strong CYP3A4 inhibitors. As a consequence, the blood pressure lowering effect may be increased. Therefore, the concomitant administration of NYMALIZE and strong CYP3A4 inhibitors should generally be avoided [see WARNINGS AND PRECAUTIONS]. Strong CYP3A4 inhibitors include some members of the following classes:
- macrolide antibiotics (e.g., clarithromycin, telithromycin,),
- HIV protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir),
- HCV protease inhibitors (e.g., boceprevir, telaprevir),
- azole antimycotics (e.g., ketoconazole, itraconazole, posaconazole, voriconazole),
- conivaptan, delaviridine, nefazodone
Nimodipine plasma concentration can also be increased in the presence of moderate and weak inhibitors of CYP3A4. If nimodipine is concomitantly administered with these drugs, blood pressure should be monitored, and a reduction of the nimodipine dose may be necessary. Moderate and weak CYP3A4 inhibitors include alprozalam, ameprenavir, amiodarone, aprepitant, atazanavir, cimetidine, cyclosporine, diltiazem, erythromycin, fluconazole, fluoxetine, isoniazid, oral contraceptives, quinuprestin/dalforpristin, valproic acid, and verapamil.
A study in eight healthy volunteers has shown a 50% increase in mean peak nimodipine plasma concentrations and a 90% increase in mean area under the curve, after a one-week course of cimetidine at 1,000 mg/day and nimodipine at 90 mg/day. This effect may be mediated by the known inhibition of hepatic cytochrome P-450 (CYP) by cimetidine, which could decrease first-pass metabolism of nimodipine.
Grapefruit juice inhibits CYP3A4. Ingestion of grapefruit/grapefruit juice is not recommended while taking nimodipine.
Nimodipine plasma concentration and efficacy may be significantly reduced when concomitantly administered with strong CYP3A4 inducers. Therefore, concomitant use of NYMALIZE with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) should generally be avoided [see WARNINGS AND PRECAUTIONS].
Moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine. Patients on these should be closely monitored for lack of effectiveness, and a nimodipine dosage increase may be required. Moderate and weak CYP3A4 inducers include, for example: amprenavir, aprepitant, armodafinil, bosentan, efavirnenz, etravirine, Echinacea, modafinil, nafcillin, pioglitazone, prednisone, rufinamide, and vemurafenib.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/23/2013
Additional Nymalize Information
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