Nimotop

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Each ivory colored, soft gelatin NIMOTOP® (nimodipine) capsule is imprinted with the word Nimotop and contains 30 mg of nimodipine. The 30 mg capsules are packaged in unit dose foil pouches and supplied in cartons containing 100 capsules. The product is also available in child resistant unit dose safety pak foil pouches containing 30 capsules per carton. The capsules should be stored in the manufacturer's original foil package at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [See USP controlled Room Temperature.]

Capsules should be protected from light and freezing.

Distributed by: Bayer Pharmaceuticals Corporation, 400 Morgan Lane, West Haven, CT 06516. Manufactured by: Catalent Pharma Solutions St. Petersburg, FL 33716. FDA revision date: 1/20/2006

Nimotop is part of the drug class:

• Dihydropyridine derivatives

Storage

Oral

25°C (may be exposed to 15–30°C) in the original container.1 Do not freeze; protect from light.1 129

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

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.

Nimotop (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)

Adverse experiences were reported by 92 of 823 patients with subarachnoid hemorrhage (11.2%) who were given nimodipine. The most frequently reported adverse experience was decreased blood pressure in 4.4% of these patients. Twenty-nine of 479 (6.1%) placebo treated patients also reported adverse experiences. The events reported with a frequency greater than 1% are displayed below by dose.

There were no other adverse experiences reported by the patients who were given 0.35 mg/kg q4h, 30 mg q4h or 120 mg q4h. Adverse experiences with an incidence rate of less than 1% in the 60 mg q4h dose group were: hepatitis; itching; gastrointestinal hemorrhage; thrombocytopenia; anemia; palpitations; vomiting; flushing; diaphoresis; wheezing; phenytoin toxicity; lightheadedness; dizziness; rebound vasospasm; jaundice; hypertension; hematoma.

Adverse experiences with an incidence rate less than 1% in the 90 mg q4h dose group were: itching, gastrointestinal hemorrhage; thrombocytopenia; neurological deterioration; vomiting; diaphoresis; congestive heart failure; hyponatremia; decreasing platelet count; disseminated intravascular coagulation; deep vein thrombosis.

As can be seen from the table, side effects that appear related to nimodipine use based on increased incidence with higher dose or a higher rate compared to placebo control, included decreased blood pressure, edema and headaches which are known pharmacologic actions of calcium channel blockers. It must be noted, however, that SAH is frequently accompanied by alterations in consciousness which lead to an under reporting of adverse experiences. Patients who received nimodipine in clinical trials for other indications reported flushing (2.1%), headache (4.1%) and fluid retention (0.3%), typical responses to calcium channel blockers. 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.

No clinically significant effects on hematologic factors, renal or hepatic function or carbohydrate metabolism have been causally associated with oral nimodipine. Isolated cases of non-fasting elevated serum glucose levels (0.8%), elevated LDH levels (0.4%), decreased platelet counts (0.3%), elevated alkaline phosphatase levels (0.2%) and elevated SGPT levels (0.2%) have been reported rarely.

There have been no reported instances of drug abuse or dependence with Nimotop

Applies to nimodipine: oral capsule liquid filled, oral solution, oral tablet

Along with its needed effects, nimodipine (the active ingredient contained in Nimotop) 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 while taking nimodipine:

• 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 of nimodipine 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:

• 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

Applies to nimodipine: oral capsule, oral liquid

Cardiovascular

Cardiovascular effects have frequently been associated with the use of nimodipine (the active ingredient contained in Nimotop) and are related to its vasodilatory properties. Mild to moderate hypotension has been reported in up to 5% of patients, and was the reason less than 1% of patients chose to discontinue therapy. Bradycardia has been reported and may be severe in rare cases. Rare cardiovascular side effects have included tachycardia, hypertension, peripheral edema, dizziness, and flushing. A case of pulmonary vasoconstriction has been associated with the use of this drug.[Ref]

Nervous system

The incidence of nervous system side effects associated with the use of nimodipine (the active ingredient contained in Nimotop) has been similar to placebo in large studies. Headache has been reported in 4% of patients, and is believed to be due to the vasodilatory properties of nimodipine.[Ref]

Hepatic

Hepatic effects include transient, reversible elevations in liver function tests.[Ref]

Hematologic

Hematologic side effects are rare and have included thrombocytopenia and anemia.[Ref]

Gastrointestinal

Gastrointestinal intolerance occurs occasionally.[Ref]

Dermatologic

Dermatologic effects include occasional cases of rash.[Ref]

Some side effects of Nimotop may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.