Generic Name and Formulations:
Nimodipine 3mg/mL; oral soln; contains ethanol.
Arbor Pharmaceuticals, LLC
Indications for NYMALIZE:
To improve neurological outcome by reducing the incidence and severity of ischemic deficits in adults with subarachnoid hemorrhage from ruptured intracranial berry aneurysms, regardless of post-ictus neurological condition.
Start within 96hrs of subarachnoid hemorrhage. Take on empty stomach. Oral: 60mg (20mL) every 4hrs for 21 consecutive days. Via NG or gastric tube: use oral syringe; flush with 20mL normal saline after each dose. Cirrhosis: 30mg (10mL) every 4hrs; monitor.
Not for IV or other parenteral administration. Monitor BP and heart rate during treatment (esp. patients w. cirrhosis). Pregnancy (Cat.C). Nursing mothers: not recommended.
Calcium channel blocker (CCB).
May potentiate effects of anti-hypertensives (eg, diuretics, beta-blockers, ACEIs, ARBs, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, α-methyldopa; monitor and adjust dose if needed. Increased risk of hypotension with concomitant strong CYP3A4 inhibitors (eg, clarithromycin, telithromycin, indinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, ketoconazole, itraconazole, posaconazole, voriconazole, conivaptan, delaviridine, nefazodone): avoid. May be potentiated by moderate and weak CYP3A4 inhibitors (eg, alprazolam, amprenavir, amiodarone, aprepitant, atazanavir, cimetidine, cyclosporine, diltiazem, erythromycin, fluconazole, fluoxetine, isoniazid, oral contraceptives, quinupristin/dalfopristin, valproic acid, verapamil); monitor and reduce nimodipine dose may be needed. Avoid concomitant grapefruit juice. Antagonized by concomitant strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. Johns wort): avoid. May be antagonized by moderate and weak CYP3A4 inducers (eg, amprenavir, aprepitant, armodafinil, bosentan, efavirenz, etravirine, Echinacea, modafinil, nafcillin, pioglitazone, prednisone, rufinamide, and vemurafenib); monitor and increase nimodipine dose may be needed.
Hypotension, headache, nausea, bradycardia.
Soln—473mL; Unit-dose cups (10mL, 20mL)—12 (w. oral syringes)