Nimodipine (Page 3 of 4)

Nursing Mothers

Nimodipine and/or its metabolites have been shown to appear in rat milk at concentrations much higher than in maternal plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, nursing mothers are advised not to breast feed their babies when taking the drug.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of nimodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dosing in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

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.

DOSE q4hNumber of Patients (%)Nimodipine
Sign/Symptom 0.35 30 mg 60 mg 90 mg 120 mg Placebo
mg/kg
(n=82) (n=71) (n=494) (n=172) (n=4) (n=479)
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
Dyspnea 1 (1.2) 0 0 0 0 0
EKG Abnormalities 0 1 (1.4) 0 1 (0.6) 0 0
Tachycardia 0 1 (1.4) 0 0 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
Acne 0 1 (1.4) 0 0 0 0
Depression 0 1 (1.4) 0 0 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.

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