(nye moe' di peen)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
Death due to inadvertent intravenous administration:
Do not administer nimodipine intravenously or by other parenteral routes. Deaths and serious, life threatening adverse events, including cardiac arrest, cardiovascular collapse, hypotension, and bradycardia, have occurred when the contents of nimodipine capsules have been injected parenterally.
|Indication(s) & Dosage||
Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
Prophylaxis of neurological deficit following subarachnoid haemorrhage
|Administration||Should be taken with food. Take immediately after meals.
|Overdose||Hypotension and bradycardia; hyperglycemia, metabolic acidosis, coma. Treatment is symptomatic.|
|Contraindication||The concomitant use of nimodipine with strong inhibitors of CYP3A4 such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some anti-HIV protease inhibitors (e.g., delaviridine, indinavir, nelfinavir, ritonavir, saquinavir), some azole antimycotics (e.g., ketoconazole, itraconazole, voriconazole) and some antidepressants (e.g., nefazadone) is contraindicated because of a risk of significant hypotension.|
|Special Precautions||Cerebral oedema, severely raised intracranial pressure, idiopathic hypertrophic subaortic stenosis (IHSS), elderly, severe liver disease. Inadvertent IV admin of the contents of capsules has resulted in CV collapse, hypotension, bradycardia and death. Tablets should not be administered concomitantly with IV solution.|
|Adverse Drug Reaction(s)||Peripheral oedema, hypotension, palpitations, tachycardia, flushing, dizziness, headache, nausea, increased micturition frequency, lethargy, eye pain, mental depression, visual disturbances, gingival hyperplasia, myalgia, tremor, impotence, fever, paradoxical increase in ischaemic chest pain during initiation of treatment, rashes, abnormalities in liver function (including cholestasis), GI obstruction in some tablets covered in indigestable membrane.
Potentially Fatal: Angina/MI, symptomatic hypotension.
|Drug Interactions||Potentiates hypotensive effect of antihypertensives. Additive effects with sildenafil, tadalafil, vardenafil. Reduced effects with calcium. Decreased levels/effects with CYP3A4 inducers (e.g aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins). Increased levels/effects with cimetidine, sodium valproate, CYP3A4 inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, and verapamil). Please consult detailed drug interactions before prescribing.|
|Food Interaction||Increased levels/effects with grapefruit juice, garlic. Decreased serum levels with St John's wort. Avoid ephedra, yohimbe, ginseng (may worsen hypertension).|
|Adverse Drug Reaction(s)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Intravenous: Store <25Â°C. Protect from light. Oral: Store <25Â°C. Protect from light.|
Mechanism of Action:Nimodipine is a calcium channel blocker. The contractile processes of smooth muscle cells are dependent upon calcium ions, which enter these cells during depolarization as slow ionic transmembrane currents. Nimodipine inhibits calcium ion transfer into these cells and thus inhibits contractions of vascular smooth muscle. In animal experiments, nimodipine had a greater effect on cerebral arteries than on arteries elsewhere in the body perhaps because it is highly lipophilic, allowing it to cross the blood-brain barrier; concentrations of nimodipine as high as 12.5 ng/mL have been detected in the cerebrospinal fluid of nimodipine-treated subarachnoid hemorrhage (SAH) patients.The precise mechanism of action of nimodipine in humans is unknown. Although the clinical studies described below demonstrate a favorable effect of nimodipine on the severity of neurological deficits caused by cerebral vasospasm following SAH, there is no arteriographic evidence that the drug either prevents or relieves the spasm of these arteries. However, whether or not the arteriographic methodology utilized was adequate to detect a clinically meaningful effect, if any, on vasospasm is unknown.
Nimodipine inhibits inflow of calcium ions into cells by blocking calcium channels or select voltage-sensitive areas resulting in relaxation of vascular smooth muscle. Nimodipine has greater action on the cerebral vessels because of its high lipophilicity.
|ATC Classification||C08CA06 - nimodipine; Belongs to the class of selective dihydropyridine derivative calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.|
Notice:Raised in the U.S. Market.
[Posted 08/02/2010] ISSUE: FDA reminded healthcare professionals that oral nimodipine (Nimotop) capsules should be given only by mouth or through a feeding or nasogastric tube and should never be given by intravenous administration. Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage (ruptured blood vessels in the brain) and is only available as a capsule. Intravenous injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications.
BACKGROUND: In 2006, FDA added a Boxed Warning and made other revisions to the prescribing information to warn against intravenous use of nimodipine. The prescribing information also provides clear instructions on how to remove the liquid contents from the capsules for nasogastric tube administration in patients who are unable to swallow. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with ''Not for IV Use.'' FDA continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences.
RECOMMENDATIONS: The Drug Safety Communication, link below, provides additional information for Healthcare Professionals, for Patients, and a Data Summary of reported medication errors. FDA will continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent medication errors with this product. For more information visit the FDA website at:http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Nimodipine is used to treat symptoms resulting from a ruptured blood vessel in the brain (hemorrhage). It increases blood flow to injured brain tissue.
This medication is sometimes prescribed for other uses; ask your doctor for more information.
How should this medicine be used?
Nimodipine comes as a capsule to take by mouth. If a patient cannot swallow the capsule, the medication can be given through a feeding tube. It is usually taken every 4 hours for 21 days. Nimodipine should be taken on an empty stomach, either 1 hour before a meal, or 2 hours after a meal. This medication should be started within 4 days of the brain hemorrhage.
Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take nimodipine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take nimodipine even if you feel well. Do not stop taking nimodipine without talking to your doctor.
Other uses for this medicine
Nimodipine is also used sometimes to treat migraine headaches. Talk to your doctor about the possible risks of using this drug for your condition.
What special precautions should I follow?
Before taking nimodipine,
- tell your doctor if you are allergic to nimodipine or any other drugs.
- tell your doctor what prescription and nonprescription medications you are taking, especially cimetidine, heart and blood pressure medicines, phenytoin, ranitidine (Zantac), and vitamins.
- tell your doctor if you have or have ever had heart, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nimodipine, call your doctor.
- if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking nimodipine.
What special dietary instructions should I follow?
Nimodipine should be taken on an empty stomach, either 1 hour before a meal or 2 hours after a meal.
Avoid drinking grapefruit juice or eating grapefruit while taking nimodipine.
Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Nimodipine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
dizziness or lightheadedness
flushing (feeling of warmth)
depression, feeling low, or the 'blues'
- unusual bruising or bleeding
If you experience any of the following symptoms, call your doctor immediately:
swelling of the face, eyes, lips, tongue, arms, or legs
difficulty breathing or swallowing
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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