Nimodipine 60mg/20ml Oral Solution

Manufacturer CAMBER PHARMACEUTICALS Active Ingredient Nimodipine Oral Solution(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
May 2011
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nimodipine is a medicine used to help prevent brain damage after a type of bleeding in the brain called a subarachnoid hemorrhage. It works by relaxing blood vessels in the brain, which helps blood flow more easily.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from this drug, take it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely.

Take this medication on an empty stomach, either 1 hour before or 2 hours after meals.
Continue taking this medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
When taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:
Store it at room temperature.
Avoid refrigerating or freezing the medication.
Protect it from light.
Keep it in a dry place, avoiding storage in a bathroom.

Missing 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 a missed dose.
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Lifestyle & Tips

  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of nimodipine in your body and lead to more side effects.
  • Take the medication exactly as prescribed, usually every 4 hours, for the full 21 days, even if you feel better.
  • Do not stop taking this medication suddenly without consulting your doctor.
  • Report any dizziness, lightheadedness, or fainting to your healthcare provider immediately.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 60 mg (20 mL) orally every 4 hours for 21 consecutive days
Dose Range: 60 - 60 mg

Condition-Specific Dosing:

subarachnoid_hemorrhage: Initiate within 96 hours of subarachnoid hemorrhage (SAH) onset.
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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 dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to potential for increased hypotensive effects.
Dialysis: Not significantly removed by hemodialysis. No specific adjustment, but monitor blood pressure closely.

Hepatic Impairment:

Mild: Consider dose reduction to 30 mg (10 mL) orally every 4 hours.
Moderate: Reduce dose to 30 mg (10 mL) orally every 4 hours.
Severe: Reduce dose to 30 mg (10 mL) orally every 4 hours. Monitor blood pressure and heart rate 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 greater effect on cerebral arteries than on peripheral arteries, leading to vasodilation and prevention of vasospasm following subarachnoid hemorrhage (SAH).
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 13%
Tmax: Approximately 1 hour
FoodEffect: High-fat meals significantly decrease Cmax and AUC. Administer on an empty stomach if possible, or consistently with food.

Distribution:

Vd: 0.9-1.6 L/kg
ProteinBinding: More than 95%
CnssPenetration: Yes

Elimination:

HalfLife: Biphasic: initial 1-2 hours, terminal 8-9 hours
Clearance: 0.4-0.6 L/kg/hr
ExcretionRoute: Approximately 50% renal, 30-40% fecal
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4-6 hours (due to short half-life, requires frequent dosing)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:

Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin, with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormally slow heartbeat
Irregular 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for advice.

Reporting Side Effects
If you have questions or concerns about side effects, you can:
Call your doctor for medical guidance
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch

Note: This is not an exhaustive list of all possible side effects. If you have any questions or concerns, consult your doctor.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fainting spells
  • Unusual weakness or tiredness
  • Slow heartbeat
  • New or worsening headache
  • Nausea or vomiting that is severe or persistent
  • Rash or allergic reaction symptoms (e.g., swelling of face/lips/tongue, difficulty 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any 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 conditions with your doctor and pharmacist. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify 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 performing 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 down position. Be particularly careful when navigating stairs.

Follow your healthcare provider's instructions for monitoring your blood pressure.

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:

  • Profound hypotension (very low blood pressure)
  • Bradycardia (very slow heart rate)
  • Flushing
  • Nausea
  • Vomiting
  • Drowsiness
  • Loss of consciousness

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and may include intravenous fluids, vasopressors, and atropine for bradycardia.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, telithromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone)
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Major Interactions

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole)
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort)
  • Other antihypertensive agents (additive hypotensive effects)
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Moderate Interactions

  • Grapefruit or grapefruit juice (increases nimodipine exposure)
  • Other calcium channel blockers (additive hypotensive effects)
  • Beta-blockers (additive hypotensive and bradycardic effects)
  • Cimetidine (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.

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation of therapy.

Neurological Status

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Every 1-4 hours initially, then as clinically indicated (e.g., every 4-8 hours) during therapy.

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

Action Threshold: Hold dose for systolic BP <90 mmHg or symptomatic hypotension; notify prescriber.

Heart Rate (HR)

Frequency: Every 1-4 hours initially, then as clinically indicated.

Target: Maintain within normal limits (e.g., 60-100 bpm).

Action Threshold: Hold dose for HR <50 bpm or symptomatic bradycardia; notify prescriber.

Neurological Status

Frequency: Regularly, at least every 4 hours, or more frequently if changes occur.

Target: Improvement or stability of neurological deficits.

Action Threshold: Any new or worsening neurological deficit; notify prescriber immediately.

Fluid Balance/Intake & Output

Frequency: Daily

Target: Maintain euvolemia.

Action Threshold: Significant fluid imbalance; notify prescriber.

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Symptom Monitoring

  • Hypotension (dizziness, lightheadedness, syncope)
  • Headache
  • Nausea/Vomiting
  • Flushing
  • Peripheral edema
  • Bradycardia
  • Rash

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 and its metabolites are 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: Risk of hypotension, bradycardia, and other adverse effects in the infant. Monitor for signs of 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 be more sensitive to the hypotensive effects of nimodipine. Initiate therapy with caution and monitor blood pressure closely. Dose adjustments may be necessary if hypotension occurs.

Clinical Information

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Clinical Pearls

  • Nimodipine oral solution must NEVER be administered intravenously. Accidental IV administration can cause severe cardiovascular events, including profound hypotension, bradycardia, and death. Always verify the route of administration.
  • The oral solution is designed for oral or nasogastric tube administration. If administering via nasogastric tube, ensure proper flushing before and after administration.
  • Administer on an empty stomach if possible, or consistently with food, to minimize variability in absorption.
  • Strict adherence to the every 4-hour dosing schedule for 21 days is crucial for optimal efficacy in preventing vasospasm after SAH.
  • Monitor blood pressure and heart rate frequently, especially during the initial days of therapy, and adjust supportive care as needed to maintain adequate cerebral perfusion pressure.
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Alternative Therapies

  • Other calcium channel blockers (e.g., nicardipine, verapamil, diltiazem - generally not used for SAH vasospasm prevention in the same manner as nimodipine)
  • Endovascular therapies (e.g., balloon angioplasty, intra-arterial vasodilators for refractory vasospasm)
  • Supportive care (e.g., induced hypertension, hypervolemia, hemodilution - 'Triple H' therapy, though its role is debated and often used in conjunction with nimodipine or for refractory cases)
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Cost & Coverage

Average Cost: Not available per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (depending on formulary)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.