nye-MOE-di-peen

• Management of subarachnoid hemorrhage.

• Inhibits the transport of calcium into vascular smooth muscle cells, resulting in inhibition of excitation-contraction coupling and subsequent contraction.
• Potent peripheral vasodilator.

• Prevention of vascular spasm after subarachnoid hemorrhage, resulting in decreased neurologic impairment.

Absorption: Well absorbed following oral administration but extensively metabolized, resulting in ↓ bioavailability.

Distribution: Crosses the blood-brain barrier; remainder of distribution unknown.

Protein Binding: >95%.

Metabolism/Excretion: Mostly metabolized by the liver; 10% excreted unchanged by kidneys.

Half-life: 1–2 hr.

Contraindicated in:

• Hypersensitivity
• Systolic BP <90 mm Hg
• Concurrent use of strong CYP3A4 inhibitors (↑ risk of hypotension)
• Concurrent use of strong CYP3A4 inducers (↓ efficacy)

Use Cautiously in:

• Severe hepatic impairment (dose ↓ recommended)
• Severe renal impairment
• History of serious ventricular arrhythmias or HF
• OB: Safety not established in pregnancy
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children
• Geri: Dose ↓ recommended due to↑ risk of hypotension in older adults.

CV: ARRHYTHMIAS, HF, chest pain, hypotension, palpitations, peripheral edema, syncope, tachycardia.

Derm: STEVENS-JOHNSON SYNDROME, dermatitis, erythema multiforme, flushing, ↑ sweating, photosensitivity, pruritus/urticaria, rash.

EENT: blurred vision, disturbed equilibrium, epistaxis, tinnitus.

Endo: gynecomastia, hyperglycemia.

GI: ↑liver enzymes, anorexia, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting.

GU: dysuria, nocturia, polyuria, sexual dysfunction, urinary frequency.

Hemat: anemia, leukopenia, thrombocytopenia.

Metab: weight gain.

MS: joint stiffness, muscle cramps.

Neuro: abnormal dreams, anxiety, confusion, dizziness, drowsiness, dysgeusia, headache, nervousness, psychiatric disturbances, weakness., paresthesia, tremor.

Resp: cough, dyspnea.

Misc: gingival hyperplasia.

Drug-Drug:

• Strong CYP3A4 inhibitors, including clarithromycin, indinavir, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, posaconazole, voriconazole, conivaptan, and nefazodone may ↑ levels and the risk of hypotension; avoid concurrent use
• Strong CYP3A4 inducers, including carbamazepine, phenobarbital, phenytoin, and rifampin may ↓ levels and effects; avoid concurrent use
• Additive hypotension may occur when used concurrently with fentanyl, other antihypertensives, nitrates, acute ingestion of alcohol, or quinidine.

Drug-Natural Products:

• St. John's wort may ↓ levels and effect; avoid concurrent use

Drug-Food:

• Grapefruit and grapefruit juice↑ levels and effect; avoid concurrent use.

• PO (Adults): 60 mg every 4 hr for 21 days; therapy should be started within 96 hr of subarachnoid hemorrhage.

• Do not confuse nimodipine with nicardipine or nifedipine.
  • Begin administration within 96 hr of subarachnoid hemorrhage and continue every 4 hr for 21 consecutive days.
• Administer by PO route ONLY; administration via IV or parenterally, may cause serious adverse events, including death.
• PO: If patient is unable to swallow capsule, make a hole in both ends of the capsule with a sterile 18-gauge needle and extract the contents into a syringe. Empty contents into water or nasogastric tube and flush with 30 mL normal saline.
  • Administer oral solution 1 hr before or 2 hr after meals. For administration via NG or gastric tube, administer via syringe included, then refill syringe with 20 mL of 0.9% saline water solution; flush remaining contents from NG or gastric tube into stomach.

Nymalize

Nimotop

Therapeutic Classification: subarachnoid hemorrhage therapy agents

Pharmacologic Classification: calcium channel blockers

(Generic available)

• Capsules: 30 mg;
• Oral solution: 6 mg/mL;

(vasodilation)

• Assess patient’s neurologic status (level of consciousness, movement) prior to and periodically following administration.
• Monitor BP and pulse prior to therapy and periodically during therapy.
• Monitor intake and output ratios and daily weight. Assess for signs of HF (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).
• Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.

• Total serum calcium concentrations are not affected by calcium channel blockers.
  • Monitor serum potassium periodically. Hypokalemia↑ risk of arrhythmias; should be corrected.
  • Monitor renal and hepatic functions periodically. Several days of therapy may cause ↑ hepatic enzymes, which return to normal upon discontinuation of therapy.
  • May occasionally cause ↓ platelet count.

• Advise patient to take medication as directed, even if feeling well. Take missed doses as soon as possible unless almost time for next dose; do not double doses. May need to be discontinued gradually.
  • Advise patient to avoid grapefruit or grapefruit juice during therapy.
  • Caution patient to change positions slowly to minimize orthostatic hypotension.
  • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of alcohol or OTC medications and herbal products, especially cold preparations, without consulting health care professional.
  • Advise patient to notify health care professional if rash, irregular heartbeats, dyspnea, swelling of hands and feet, pronounced dizziness, nausea, constipation, or hypotension occurs or if headache is severe or persistent.
  • Caution patient to wear protective clothing and use sunscreen to prevent photosensitivity reactions.
  • Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breast feeding.

• Improvement in neurologic deficits due to vasospasm following subarachnoid hemorrhage.

NDC Code^*

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-108- Nimodipine
    • 23155-108-00- 10 BLISTER PACK in 1 CARTON (23155-108-00) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-108-11)

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-108- Nimodipine
    • 23155-108-30- 3 BLISTER PACK in 1 CARTON (23155-108-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-108-11)

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-512- Nimodipine
    • 23155-512-00- 10 BLISTER PACK in 1 CARTON (23155-512-00) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-512-11)

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-512- Nimodipine
    • 23155-512-30- 3 BLISTER PACK in 1 CARTON (23155-512-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-512-11)

• 24338- Arbor Pharmaceuticals
  • 24338-200- Nymalize
    • 24338-200-12- 12 PACKAGE in 1 CARTON (24338-200-12) > 1 CUP, UNIT-DOSE in 1 PACKAGE (24338-200-20) > 20 mL in 1 CUP, UNIT-DOSE

• 24338- Arbor Pharmaceuticals
  • 24338-200- Nymalize
    • 24338-200-16- 473 mL in 1 BOTTLE (24338-200-16)

• 24338- Arbor Pharmaceuticals
  • 24338-205- Nymalize
    • 24338-205-12- 12 PACKAGE in 1 CARTON (24338-205-12) > 1 CUP, UNIT-DOSE in 1 PACKAGE (24338-205-10) > 10 mL in 1 CUP, UNIT-DOSE

• 55154- Cardinal Health
  • 55154-4184- Nimodipine
    • 55154-4184-0- 10 BLISTER PACK in 1 BAG (55154-4184-0) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• 57664- Caraco Pharmaceutical Laboratories, Ltd.
  • 57664-135- Nimodipine
    • 57664-135-64- 30 BLISTER PACK in 1 CARTON (57664-135-64) > 1 CAPSULE in 1 BLISTER PACK (57664-135-60)

• 57664- Caraco Pharmaceutical Laboratories, Ltd.
  • 57664-135- Nimodipine
    • 57664-135-65- 100 BLISTER PACK in 1 CARTON (57664-135-65) > 1 CAPSULE in 1 BLISTER PACK (57664-135-60)

• 62559- ANI Pharmaceuticals, Inc.
  • 62559-210- Nimodipine
    • 62559-210-31- 30 CAPSULE in 1 CARTON (62559-210-31)

• 62559- ANI Pharmaceuticals, Inc.
  • 62559-210- Nimodipine
    • 62559-210-52- 10 CAPSULE in 1 BLISTER PACK (62559-210-52)

• 62559- ANI Pharmaceuticals, Inc.
  • 62559-210- Nimodipine
    • 62559-210-81- 100 CAPSULE in 1 CARTON (62559-210-81)

• 63739- McKesson Corporation dba SKY Packaging
  • 63739-797- Nimodipine
    • 63739-797-33- 3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-797-33) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• 67877- Ascend Laboratories, LLC
  • 67877-297- Nimodipine
    • 67877-297-30- 30 CAPSULE, LIQUID FILLED in 1 PACKAGE (67877-297-30)

• 67877- Ascend Laboratories, LLC
  • 67877-297- Nimodipine
    • 67877-297-38- 100 CAPSULE, LIQUID FILLED in 1 PACKAGE (67877-297-38)

• 68084- American Health Packaging
  • 68084-912- Nimodipine
    • 68084-912-31- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-912-31) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68084-912-33)

• 68084- American Health Packaging
  • 68084-912- Nimodipine
    • 68084-912-32- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-912-32) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68084-912-33)

• 69452- BIONPHARMA INC.
  • 69452-209- Nimodipine
    • 69452-209-13- 3 BLISTER PACK in 1 CARTON (69452-209-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• 69452- BIONPHARMA INC.
  • 69452-209- Nimodipine
    • 69452-209-20- 10 BLISTER PACK in 1 CARTON (69452-209-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK