Generic drug: nimodipine
Brand name: Nymalize
What is Nymalize (nimodipine), and how does it work?
Nymalize (nimodipine) is a calcium channel blocker used to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage, SAH).
What are the side effects of Nymalize?
Common side effects of Nymalize include:
- decreased blood pressure
- headache
- nausea
- slowed heart rate
- swelling (edema)
- diarrhea
- rash
- indigestion
- fast heart rate
- muscle pain or cramps
- acne, or
- depression
What is the dosage for Nymalize?
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.
Administration By Oral Route
The recommended oral dosage is 10 mL (60 mg) every 4 hours for 21 consecutive days.
Administration Via Nasogastric Or Gastric Tube
Using the supplied prefilled oral syringe labeled “For Oral Use Only”, administer 10 mL (60 mg) every 4 hours into a nasogastric or gastric tube for 21 consecutive days. For each dose, refill the syringe with 10 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 5 mL (30 mg) every 4 hours.
What drugs interact with Nymalize?
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, nimodipinewas 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.
CYP3A4 Inhibitors
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. 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, delavirdine, 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/dalfopristin,
- 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.
CYP3A4 Inducers
- 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. - 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.
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Is Nymalize safe to use while pregnant or breastfeeding?
- There are no adequate data on the developmental risk associated with the use of
Nymalize in pregnant women. - Nimodipine has been detected in human milk. There are no data on the effects of nimodipine on the breastfed infant or on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
Nymalize and any potential adverse effects on the breastfed infant from
Nymalize or from the underlying maternal condition.