Nymalize

Do not drink grapefruit juice or eat grapefruit while you are taking nimodipine.

Nimodipine is a calcium channel blocker. Nimodipine relaxes (widens) blood vessels and improves blood flow.

Nimodipine is used to prevent brain damage caused by reduced blood flow to the brain resulting from aneurysm (AN-yor-iz-m), a dilated or ruptured blood vessel in the brain.

Nimodipine may also be used for purposes other than those listed here.

Some medicines can interact with nimodipine and should not be used at the same time. Tell your doctor about all your medications and any you start or stop using during treatment with nimodipine.

Nimodipine can lower your blood pressure. Call your doctor at once if you feel like you might pass out.

The liquid from a nimodipine capsule should never be injected through a needle into the body, or dangerously low blood pressure may result. Nimodipine gel capsules are to be taken by mouth only.

You should not use nimodipine if you are allergic to it.

Some medicines can interact with nimodipine and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• conivaptan;
• imatinib;
• nefazodone;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
• heart medication--nicardipine, quinidine;
• hepatitis C medications--boceprevir, telaprevir; or
• HIV/AIDS medication--atazanavir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

To make sure nimodipine is safe for you, tell your doctor if you have:

• cirrhosis or other liver disease;
• heart disease; or
• high or low blood pressure.

FDA pregnancy category C. It is not known whether nimodipine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nimodipine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• easy bruising or bleeding;
• fast or slow heart rate; or
• swelling in your ankles or feet.

Common side effects may include:

• nausea, diarrhea, upset stomach;
• headache; or
• mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Grapefruit and grapefruit juice may interact with nimodipine and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking nimodipine.

Drinking alcohol can increase certain side effects of nimodipine.

Many drugs can interact with nimodipine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with nimodipine, especially:

• St. John's wort;
• seizure medication--carbamazepine, fosphenytoin, phenobarbital, phenytoin, and others;
• sildenafil (Viagra) and other erectile dysfunction medicines; or
• tuberculosis medications.

This list is not complete and many other drugs can interact with nimodipine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nymalize falls into category  C. There are no well-controlled studies in pregnant women. Nymalize should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Some medicines can interact with nimodipine and should not be used at the same time. Tell your doctor about all your medications and any you start or stop using during treatment with nimodipine.

Nimodipine can lower your blood pressure. Call your doctor at once if you feel like you might pass out.

The liquid from a nimodipine capsule should never be injected through a needle into the body, or dangerously low blood pressure may result. Nimodipine gel capsules are to be taken by mouth only.

Grapefruit and grapefruit juice may interact with nimodipine and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking nimodipine.

Drinking alcohol can increase certain side effects of nimodipine.

Many drugs can interact with nimodipine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with nimodipine, especially:

• St. John's wort;

• seizure medication--carbamazepine, fosphenytoin, phenobarbital, phenytoin, and others;

• sildenafil (Viagra) and other erectile dysfunction medicines; or

• tuberculosis medications.

This list is not complete and many other drugs can interact with nimodipine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

This section provides information on the proper use of a number of products that contain nimodipine. It may not be specific to Nymalize. Please read with care.

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.

The safety and efficacy of Nymalize (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH. Nymalize (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules.

The following clinically significant adverse reaction appears in other sections of the labeling:

• Hypotension [see Warnings and Precautions (5.1)].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In clinical trials of nimodipine oral capsules in patients with SAH, eleven percent (92 of 823) of nimodipine-treated patients reported adverse events compared to six percent (29 of 479) of placebo-treated patients. The most common adverse event was decreased blood pressure in 4.4% of nimodipine-treated patients. The events reported with a frequency greater than 1% are displayed in Table 1 by dose.

SAH is frequently accompanied by alterations in consciousness that may lead to an under-reporting of adverse experiences. As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed in SAH trials.

There have been no reports of overdosage from the oral administration of nimodipine. Symptoms of overdosage would be expected to be related to cardiovascular effects such as excessive peripheral vasodilation with marked systemic hypotension. Clinically significant hypotension due to nimodipine overdosage may require active cardiovascular support with pressor agents and specific treatments for calcium channel blocker overdose. Since nimodipine is highly protein-bound, dialysis is not likely to be of benefit.