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Nymalize

"On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was av"...

Nymalize

Nymalize

Nymalize Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nymalize (nimodipine) is a calcium channel blocker used to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage, SAH). The most common side effects from the use of Nymalize are decreased blood pressure, headache, nausea, and slowed heart rate.

Nymalize oral solution is available in dosages of 60mg/20mL and should be administered by way of oral, nasogastric tube, or gastric tube route only. Therapy with Nymalize should begin within 96 hours of subarachnoid hemorrhage. Nymalize may interact with high blood pressure medications, St. John's Wort, anticonvulsants, and antibiotics. Tell your doctor all medications you use. Nymalize may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Nymalize is passes into human milk. Because many drugs are excreted in human milk and because of the potential for serious side effects in babies who breastfeed, consult your doctor before breastfeeding.

Nymalize (nimodipine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nymalize FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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:

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 nimodipinetreated 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.

Table 1: Adverse Events [n (%)] reported with a frequency > 1% in four clinical trials (Study 1, Study 2, Study 3, and Study 4)

  Placebo
(n=479)
Nimodipine dose every 4 hours
0.35 mg/kg
(n=82)
30 mg
(n=71)
60 mg
(n=494)
90 mg
(n=172)
120 mg
(n=4)
Decreased Blood Pressure 6 (1.2) 1 (1.2) 0 19 (3.8) 14 (8.1) 2 (50.0)
Edema 3 (0.6) 0 0 2 (0.4) 2 (1.2) 0
Diarrhea 3 (0.6) 0 3 (4.2) 0 3 (1.7) 0
Rash 3 (0.6) 2 (2.4) 0 3 (0.6) 2 (1.2) 0
Headache 1 (0.2) 0 1 (1.4) 6 (1.2) 0 0
Gastrointestinal Symptoms 0 2 (2.4) 0 0 2 (1.2) 0
Nausea 0 1 (1.2) 1 (1.4) 6 (1.2) 1 (0.6) 0
Dyspnea 0 1 (1.2) 0 0 0 0
EKG Abnormalities 0 0 1 (1.4) 0 1 (0.6) 0
Tachycardia 0 0 1 (1.4) 0 0 0
Bradycardia 0 0 0 5 (1.0) 1 (0.6) 0
Muscle Pain/Cramp 0 0 1 (1.4) 1 (0.2) 1 (0.6) 0
Acne 0 0 1 (1.4) 0 0 0
Depression 0 0 1 (1.4) 0 0 0

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.

Read the entire FDA prescribing information for Nymalize (Nimodipine Oral Solution) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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