Pronunciation:

nye-MOE-di-peen

Brand Names:

• Nimotop
• Nymalize

Dosage Forms:

• Capsule, Liquid Filled
• Solution

Warnings:

Do not administer nimodipine intravenously or by other parenteral routes. Deaths and serious, life threatening adverse events have occurred when the contents of nimodipine capsules have been injected parenterally .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Calcium Channel Blocker

Chemical—

Dihydropyridine

Uses of This Medicine:

Nimodipine is used to treat symptoms resulting from a ruptured blood vessel in the brain (subarachnoid hemorrhage). It works by increasing the blood flow to injured brain tissue.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nimodipine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nimodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving nimodipine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir
• Clarithromycin
• Conivaptan
• Delavirdine
• Indinavir
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Ceritinib
• Clopidogrel
• Cobicistat
• Dantrolene
• Darunavir
• Dexamethasone
• Digoxin
• Epirubicin
• Fosphenytoin
• Itraconazole
• Lacosamide
• Melphalan
• Phenobarbital
• Phenytoin
• Rifampin
• Rifapentine
• St John's Wort

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dalfopristin
• Quinupristin
• Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed even if you feel well and do not notice any symptoms. Do not take more of this medicine and do not take it more often than your doctor ordered. Do not miss any doses.

This medicine is usually given within 96 hours of having the condition. It is best to take this medicine at least 1 hour before or 2 hours after a meal.

If the capsule cannot be swallowed or if you are using this medicine with a nasogastric tube (NGT), you may put a hole in both ends of the capsule and remove its contents using a syringe. Use the syringe to give the medicine orally or through the NGT. Do not use it to give the medicine as an injection through the veins, muscles, or skin.

If you are using the oral liquid:

• Measure your dose with a marked measuring spoon, oral syringe, or medicine cup.
• If the medicine is going to be given through a nasogastric or gastric tube, use the oral syringe that comes with the package to measure the dose. For each dose, refill the syringe with saline solution to flush any remaining medicine in the nasogastric tube into the stomach.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For subarachnoid hemorrhage:
  • For oral dosage form (capsules):
    • Adults—60 milligrams (mg) or two 30 mg capsules every 4 hours for 21 days.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—20 milliliters (mL) (60 milligrams [mg]) every 4 hours for 21 consecutive days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate the oral liquid.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

You will need to have your blood pressure measured during treatment with this medicine. If you notice any changes to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Dizziness, lightheadedness, or fainting may also occur while using this medicine. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

chest pain or discomfort

confusion

difficult or labored breathing

fast, pounding, or irregular heartbeat or pulse

lightheadedness, dizziness, or fainting

shortness of breath

slow or irregular heartbeat

sweating

swelling

tightness in the chest

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal or stomach cramps, discomfort, or pain

back pain

blemishes on the skin

constipation

diarrhea

discouragement

feeling sad or empty

headache

indigestion

irritability

lack or loss of appetite

loss of interest or pleasure

muscle pain

nausea or vomiting

pimples

rash

swollen mouth and tongue

tiredness

trouble concentrating

trouble sleeping

unpleasant taste

urge to have bowel movement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.