Nimotop (Oral)

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

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

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to check for any 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 coming back.

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 (e.g., St John's wort) or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of nimodipine in children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems for older adults that would limit the usefulness of nimodipine. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution when using nimodipine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you are taking this medicine, it is especially important that your healthcare professional knows if you are using any of the following medicines. The following interactions are based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take 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 increase the 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 take one or both of the medicines.

• Dalfopristin
• Quinupristin
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are based on 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 take this medicine, or give you special instructions regarding food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because the medicine may be removed from the body more slowly.

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.

In the U.S.

• Nimotop
• Nymalize

Available Dosage Forms:

• Capsule, Liquid Filled
• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

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.