| IMPORTANT WARNING:
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
[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: Web Siteand Web Site.
WHY is this medicine 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 or pharmacist 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 or pharmacist 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.
Are there 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 and pharmacist if you are allergic to nimodipine or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially cimetidine (Tagamet), heart and blood pressure medicines, phenytoin (Dilantin), 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 to take 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 medicine 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)
- fast heartbeat
- slow heartbeat
- upset stomach
- stomach pain
- 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
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
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.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
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.
¶This branded product is no longer on the market. Generic alternatives may be available.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: August 1, 2010.