"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
Nimotop Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Nimotop (nimodipine) Capsules are calcium channel blockers and are available in generic form. The drug 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). Side effects may include but are not limited to: unusually fast or slow heartbeats, fainting, and hypotension.
The oral dose is 60 mg (two 30 mg capsules) every 4 hours for 21 consecutive days, preferably not less than one hour before or two hours after meals. Oral Nimotop therapy should commence within 96 hours of the subarachnoid hemorrhage. Deaths and serious, life threatening adverse events, including cardiac arrest, cardiovascular collapse, hypotension, and bradycardia, have occurred when the contents of Nimotop Capsules have been injected parenterally. There are no adequate and well controlled studies in pregnant women to directly assess the effect on human fetuses. Nimodipine should be used during pregnancy or during breastfeeding only if the potential benefit justifies the potential risk to the fetus or infant.
Our Nimotop (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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Nimotop in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using nimodipine and call your doctor at once if you have any of these serious side effects:
- unusually fast or slow heartbeats;
- fainting or severe dizziness;
- easy bruising or bleeding, unusual weakness;
- swelling in your legs or ankles.
Other, less serious side effects may be more likely. Continue taking nimodipine and talk to your doctor if you have any of these less serious side effects:
- mild dizziness;
- flushing (redness, warmth, or tingling feeling);
- nausea, constipation; or
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Nimotop (Nimodipine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Nimotop Overview - Patient Information: Side Effects
To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, slow/fast heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe abdominal pain, stomach bloating, inability to have a bowel movement for more than 3 days, severe nausea/vomiting, vision changes.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Nimotop (Nimodipine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Nimotop FDA Prescribing Information: 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 entire FDA prescribing information for Nimotop (Nimodipine) »
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