Nimodipine 30mg Capsules

Manufacturer HERITAGE Active Ingredient Nimodipine Capsules(nye MOE di peen) Pronunciation nye MOE di peen
WARNING: Do not give this drug as a shot. Unsafe and sometimes deadly effects may happen. @ COMMON USES: It is used to help lower bad effects caused by bleeding in the brain.
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Drug Class
Calcium Channel Blocker
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Pharmacologic Class
Dihydropyridine Calcium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Jun 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nimodipine is a medication used to help prevent brain damage after a type of bleeding in the brain called a subarachnoid hemorrhage. It works by relaxing the blood vessels in the brain, which helps to improve blood flow and prevent complications like vasospasm.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication on an empty stomach, either 1 hour before or 2 hours after meals. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

To maintain the quality and effectiveness of your medication, store it in its original container at room temperature. Protect the container from light and keep it in a dry place. Avoid storing your medication in a bathroom.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually every 4 hours, for the full 21 days, even if you feel better.
  • Do not crush, chew, or open the capsules; swallow them whole.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of nimodipine in your body and lead to side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially antibiotics, antifungals, or seizure medications.
  • Report any symptoms of dizziness, lightheadedness, or fainting to your doctor immediately, as these could be signs of low blood pressure.
  • Do not stop taking this medication suddenly without consulting your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 60 mg (two 30mg capsules) orally every 4 hours for 21 consecutive days
Dose Range: 60 - 60 mg

Condition-Specific Dosing:

subarachnoid_hemorrhage_prophylaxis: Initiate within 96 hours of subarachnoid hemorrhage (SAH).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution.
Dialysis: Not significantly removed by dialysis; no specific dose adjustment, but monitor for adverse effects.

Hepatic Impairment:

Mild: Consider dose reduction to 30 mg every 4 hours.
Moderate: Consider dose reduction to 30 mg every 4 hours.
Severe: Consider dose reduction to 30 mg every 4 hours or discontinue. Monitor blood pressure closely.

Pharmacology

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Mechanism of Action

Nimodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells. It has a higher selectivity for cerebral blood vessels, preventing or reversing vasospasm following subarachnoid hemorrhage (SAH) by relaxing cerebral vascular smooth muscle.
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Pharmacokinetics

Absorption:

Bioavailability: 13%
Tmax: 0.6-1.6 hours
FoodEffect: High-fat meal significantly reduces absorption (up to 68% reduction in Cmax and 52% in AUC).

Distribution:

Vd: 0.9-2.3 L/kg
ProteinBinding: >95%
CnssPenetration: Yes

Elimination:

HalfLife: Biphasic: initial 1-2 hours, terminal 8-9 hours
Clearance: Not available
ExcretionRoute: Feces (50%), urine (30%)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Not precisely defined for clinical effect in SAH, but plasma concentrations peak within 1-2 hours.
PeakEffect: Not precisely defined for clinical effect in SAH.
DurationOfAction: Not precisely defined, but dosing every 4 hours suggests a relatively short duration of effect requiring frequent administration.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Slow heartbeat
Abnormal heartbeat
Shortness of breath
Sudden significant weight gain
Swelling in the arms or legs

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fainting
  • Unusual tiredness or weakness
  • Swelling in your ankles or feet
  • New or worsening headache
  • Changes in heart rate (too slow or too fast)
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug and should not be taken concurrently. Your doctor or pharmacist can provide guidance on potential interactions.
* Please note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.

To ensure your safety, it is vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when engaging in activities that require your full attention, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be particularly careful when navigating stairs.

Follow your healthcare provider's instructions for monitoring your blood pressure. Additionally, avoid consuming grapefruit and grapefruit juice while taking this medication.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Marked hypotension (very low blood pressure)
  • Bradycardia (slow heart rate)
  • Tachycardia (fast heart rate)
  • Flushing
  • Nausea
  • Vomiting
  • Drowsiness
  • Confusion
  • Loss of consciousness

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and may include intravenous fluids, vasopressors for hypotension, and atropine for bradycardia.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inducers (e.g., rifampin, phenobarbital, phenytoin, carbamazepine) due to significant reduction in nimodipine plasma concentrations and loss of efficacy.
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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, telithromycin, ritonavir, indinavir, nelfinavir, saquinavir) due to increased nimodipine plasma concentrations and risk of hypotension.
  • Other antihypertensive agents (e.g., beta-blockers, diuretics, ACE inhibitors) due to additive hypotensive effects.
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Moderate Interactions

  • Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, fluconazole, grapefruit juice) due to increased nimodipine plasma concentrations.
  • Cimetidine, valproic acid (may increase nimodipine levels).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and monitor for hypotension, a common side effect.

Timing: Prior to initiation of therapy.

Neurological Status

Rationale: To assess baseline neurological function and monitor for changes related to SAH or drug effects.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

Rationale: Nimodipine is extensively metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.

Timing: Prior to initiation, if hepatic impairment is suspected.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., every 4 hours or as clinically indicated) during therapy.

Target: Maintain within a safe range to ensure cerebral perfusion while avoiding symptomatic hypotension.

Action Threshold: Symptomatic hypotension or significant drop from baseline; consider dose reduction or temporary interruption.

Neurological Status

Frequency: Regularly (e.g., every 4 hours or as clinically indicated) during therapy.

Target: Stable or improving neurological status.

Action Threshold: Worsening neurological status (e.g., new focal deficits, decreased level of consciousness) may indicate vasospasm or other complications, requiring further evaluation.

Fluid Balance/Input-Output

Frequency: Daily

Target: Maintain euvolemia.

Action Threshold: Significant fluid imbalance, as hypovolemia can exacerbate hypotension.

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Symptom Monitoring

  • Headache
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Edema
  • Bradycardia
  • Hypotension (symptoms like fainting, weakness)
  • Signs of worsening neurological function (e.g., confusion, weakness, speech difficulties)

Special Patient Groups

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Pregnancy

Nimodipine is Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies.
Second Trimester: Potential for developmental toxicity observed in animal studies.
Third Trimester: Potential for developmental toxicity observed in animal studies.
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Lactation

Nimodipine is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately Safe) - Potential for hypotension, bradycardia, or other calcium channel blocker effects in the infant. Monitor infant for adverse effects.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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Geriatric Use

Elderly patients may have increased bioavailability of nimodipine and may be more sensitive to its hypotensive effects. Close monitoring of blood pressure is recommended, and a lower starting dose (e.g., 30 mg every 4 hours) may be considered, especially in those with hepatic impairment.

Clinical Information

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Clinical Pearls

  • Nimodipine is highly specific for cerebral vasculature and is the only calcium channel blocker indicated for improving neurological outcome and reducing mortality in patients with subarachnoid hemorrhage (SAH).
  • It is crucial to administer nimodipine orally. Accidental intravenous administration of oral nimodipine has led to severe adverse events, including death, due to profound hypotension and cardiovascular collapse.
  • Always check for drug interactions, especially with CYP3A4 inhibitors (e.g., azole antifungals, macrolides, grapefruit juice) and inducers (e.g., rifampin, anticonvulsants), as these can significantly alter nimodipine levels.
  • Patients should be monitored closely for hypotension, especially at the initiation of therapy or with dose adjustments.
  • Ensure patients swallow the capsules whole; do not crush, chew, or open them.
  • The full 21-day course of therapy is important for optimal benefit, even if the patient's neurological status improves.
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Alternative Therapies

  • Other calcium channel blockers (e.g., nicardipine, verapamil) are not indicated for the specific purpose of preventing vasospasm after SAH.
  • Endovascular therapies (e.g., angioplasty, intra-arterial vasodilators) may be used to treat established cerebral vasospasm, but not as prophylaxis in place of nimodipine.
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Cost & Coverage

Average Cost: Varies, typically $50-$200 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.