"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
- Patient Information:
Details with Side Effects
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.
Number of Patients
|Decreased Blood Pressure||1 (1.2)||0||19 (3.8)||14 (8.1)||2 (50.0)||6 (1.2)|
|Abnormal Liver Function Test||1 (1.2)||0||2 (0.4)||1 (0.6)||0||7 (1.5)|
|Edema||0||0||2 (0.4)||2 (1.2)||0||3 (0.6)|
|Diarrhea||0||3 (4.2)||0||3 (1.7)||0||3 (0.6)|
|Rash||2 (2.4)||0||3 (0.6)||2 (1.2)||0||3 (0.6)|
|Headache||0||1 (1.4)||6 (1.2)||0||0||1 (0.2)|
|Gastrointestinal Symptoms||2 (2.4)||0||0||2 (1.2)||0||0|
|Nausea||1 (1.2)||1 (1.4)||6 (1.2)||1 (0.6)||0||0|
|EKG Abnormalities||0||1 (1.4)||0||1 (0.6)||0||0|
|Bradycardia||0||0||5 (1.0)||1 (0.6)||0||0|
|Muscle Pain/Cramp||0||1 (1.4)||1 (0.2)||1 (0.6)||0||0|
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.
Drug Abuse And Dependence
There have been no reported instances of drug abuse or dependence with Nimotop® (nimodipine) .
Read the Nimotop (nimodipine) Side Effects Center for a complete guide to possible side effects
It is possible that the cardiovascular action of other calcium channel blockers could be enhanced by the addition of Nimotop® (nimodipine) .
In Europe, Nimotop® (nimodipine) was observed to occasionally intensify the effect of antihypertensive compounds taken concomitantly by patients suffering from hypertension; this phenomenon was not observed in North American clinical trials.
A study in eight healthy volunteers has shown a 50% increase in mean peak nimodipine plasma concentrations and a 90% increase in mean area under the curve, after a one-week course of cimetidine at 1,000 mg/day and nimodipine at 90 mg/day. This effect may be mediated by the known inhibition of hepatic cytochrome P-450 by cimetidine, which could decrease first-pass metabolism of nimodipine.
Read the Nimotop Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Nimotop Information
Nimotop - User Reviews
Nimotop User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.