Verapamil ER 300mg Capsules (24 Hr)

Manufacturer KREMERS Active Ingredient Verapamil Long-Acting Capsules(ver AP a mil) Pronunciation ver-AP-a-mil
It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Antiarrhythmic, Antianginal
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Pharmacologic Class
Calcium Channel Blocker (Non-dihydropyridine)
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Pregnancy Category
Category C
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FDA Approved
Jun 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Verapamil is a medication that helps relax blood vessels and slow down your heart rate. This makes it easier for your heart to pump blood, which can lower high blood pressure, relieve chest pain (angina), and help control certain irregular heart rhythms.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.

Some medications are best taken at bedtime, while others can be taken at any time. If you're unsure about when to take your medication, consult with your pharmacist.

When taking your medication, swallow the tablet or capsule whole. Do not chew or crush it. If you have difficulty swallowing the medication whole, you can sprinkle the contents onto a small amount of applesauce. However, be sure to swallow the mixture immediately without chewing. Avoid mixing the medication with hot applesauce.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom.

Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.

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 your medication exactly as prescribed, usually once daily. Do not crush, chew, or break extended-release capsules.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of verapamil in your body and lead to side effects.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effects.
  • Maintain a healthy diet, regular exercise, and manage stress to support cardiovascular health.

Dosing & Administration

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Adult Dosing

Standard Dose: 240 mg to 480 mg once daily (extended-release)
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180 mg to 240 mg once daily; adjust dose weekly. Max: 480 mg/day.
angina: Initial: 180 mg to 240 mg once daily; adjust dose weekly. Max: 480 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for extended-release capsules. Immediate-release forms may be used for specific indications under specialist supervision.
Adolescent: Not established for extended-release capsules.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment usually needed, monitor for exaggerated effects.
Moderate: No specific adjustment usually needed, monitor for exaggerated effects.
Severe: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
Dialysis: Verapamil is not removed by hemodialysis. Use with caution, monitor for exaggerated effects.

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 120 mg ER daily).
Moderate: Reduce dose significantly (e.g., 30% of normal dose) and titrate slowly. Monitor closely.
Severe: Contraindicated or use with extreme caution and significant dose reduction (e.g., 25% of normal dose). Monitor closely.

Pharmacology

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Mechanism of Action

Verapamil is a non-dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle cells. This leads to relaxation of vascular smooth muscle, resulting in vasodilation and reduced peripheral vascular resistance. In the heart, it decreases myocardial contractility, slows sinoatrial (SA) node automaticity, and prolongs atrioventricular (AV) node conduction, thereby reducing heart rate and improving coronary blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: 20-35% (due to extensive first-pass metabolism)
Tmax: Extended-release: 7-9 hours
FoodEffect: Food may increase bioavailability slightly but generally does not significantly alter absorption of ER formulations; can be taken with or without food.

Distribution:

Vd: 1.8-5.0 L/kg
ProteinBinding: 90%
CnssPenetration: Limited

Elimination:

HalfLife: Extended-release: 4-12 hours (single dose), 8-15 hours (multiple doses)
Clearance: 0.5-1.0 L/kg/hr
ExcretionRoute: 70% renal, 16% fecal
Unchanged: 3-4% (renal)
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Pharmacodynamics

OnsetOfAction: Extended-release: 2-5 hours
PeakEffect: Extended-release: 7-9 hours
DurationOfAction: Extended-release: 24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Slow heartbeat
New or worsening abnormal heartbeat
Severe dizziness or fainting
Shortness of breath, significant weight gain, or 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. Contact your doctor or seek medical help if you experience:

Dizziness or headache
Constipation

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting spells
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • New or worsening shortness of breath
  • Significant swelling in your ankles, feet, or legs
  • Severe or persistent constipation
  • Chest pain that worsens or does not improve
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Heart failure (a weakened heart)
+ Specific types of abnormal heart rhythms, including heart block, Lown-Ganong-Levine syndrome, sick sinus syndrome, or Wolff-Parkinson-White syndrome
+ Low blood pressure
+ A slow heartbeat
Medications you are currently taking, including:
+ Dofetilide, ivabradine, or quinidine
+ Beta blockers like atenolol, metoprolol, or propranolol
If you have taken disopyramide or flibanserin within the last 48 hours
* If you are breastfeeding, as you should not breastfeed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Follow your doctor's instructions for monitoring your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor, and discuss any concerns or questions with them.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Before consuming alcohol, discuss it with your doctor. If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor about potential interactions.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant or planning to become pregnant, inform your doctor. You will need to discuss the benefits and risks of using this medication during pregnancy to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • High-degree AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Metabolic acidosis
  • Hyperglycemia
  • Confusion
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve IV fluids, calcium gluconate, atropine, vasopressors, glucagon, or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Beta-blockers (IV, due to risk of severe bradycardia and asystole)
  • Disopyramide (risk of severe myocardial depression)
  • Dantrolene (IV, risk of cardiovascular collapse)
  • Ivabradine (risk of excessive bradycardia)
  • Colchicine (in patients with renal or hepatic impairment, due to increased colchicine levels)
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Major Interactions

  • Beta-blockers (oral, increased risk of bradycardia, AV block, heart failure)
  • Digoxin (increased digoxin levels, risk of toxicity)
  • Statins (e.g., simvastatin, lovastatin; increased statin levels, risk of myopathy/rhabdomyolysis)
  • Amiodarone (increased risk of bradycardia, AV block, hypotension)
  • Flecainide (increased risk of myocardial depression, AV block)
  • Quinidine (increased quinidine levels, hypotension, pulmonary edema)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin; increased verapamil levels)
  • CYP3A4 inducers (e.g., rifampin, phenobarbital, phenytoin; decreased verapamil levels)
  • Grapefruit juice (increased verapamil levels)
  • Fentanyl (increased risk of severe hypotension, bradycardia)
  • Midazolam, Triazolam (increased benzodiazepine levels)
  • Theophylline (increased theophylline levels)
  • Carbamazepine (increased carbamazepine levels, toxicity)
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin; increased risk of hypotension)
  • Clonidine (increased risk of AV block)
  • Lithium (increased lithium levels, neurotoxicity)
  • Cyclosporine, Tacrolimus, Sirolimus, Everolimus (increased immunosuppressant levels)
  • Buspirone (increased buspirone levels)
  • Imipramine (increased imipramine levels)
  • Metformin (increased metformin levels)
  • Sulfonylureas (increased risk of hypoglycemia)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension/angina.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia risk.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block, sick sinus syndrome) which are contraindications or require caution.

Timing: Prior to initiation

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function Tests (RFTs)

Rationale: To assess kidney function, though dose adjustment is less critical than for hepatic impairment, caution is advised in severe renal dysfunction.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly)

Target: Individualized based on indication (e.g., <130/80 mmHg for hypertension)

Action Threshold: Persistent hypotension (<90/60 mmHg or symptomatic hypotension) or uncontrolled hypertension

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly)

Target: 50-90 bpm (unless target for specific arrhythmia)

Action Threshold: Bradycardia (<50 bpm or symptomatic bradycardia)

ECG (PR interval)

Frequency: Periodically, especially with dose increases or co-administration of other AV nodal blocking agents

Target: <0.20 seconds (normal PR interval)

Action Threshold: Significant PR prolongation (>0.24 seconds) or development of higher-degree AV block

Signs/Symptoms of Heart Failure or Peripheral Edema

Frequency: At each clinical visit

Target: Absence of new or worsening symptoms

Action Threshold: Development of dyspnea, orthopnea, peripheral edema, or weight gain

Bowel Habits (Constipation)

Frequency: At each clinical visit

Target: Regular bowel movements

Action Threshold: Severe or persistent constipation

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Slow heart rate (bradycardia)
  • Shortness of breath
  • Swelling in ankles, feet, or legs (peripheral edema)
  • Chest pain (worsening angina)
  • Severe constipation
  • Fatigue
  • Headache

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data; human data limited.
Second Trimester: Potential for fetal harm based on animal data; human data limited.
Third Trimester: Potential for fetal harm based on animal data; human data limited. May inhibit uterine contractions.
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Lactation

Verapamil is excreted in breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor the infant for bradycardia, hypotension, and sedation. L3 (Moderate risk).

Infant Risk: Low to moderate risk. Potential for bradycardia, hypotension, or sedation in the infant, especially in neonates or with high maternal doses. Monitor infant closely.
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Pediatric Use

Safety and efficacy of extended-release verapamil capsules have not been established in pediatric patients. Immediate-release forms may be used for specific indications (e.g., supraventricular tachycardia) under specialist supervision, with careful dose titration and monitoring.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive and bradycardic effects of verapamil due to age-related decreases in hepatic and renal function. Lower initial doses and slower titration are recommended. Monitor closely for adverse effects, especially constipation and orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Verapamil ER should be swallowed whole; do not crush, chew, or divide, as this can lead to rapid release and increased side effects.
  • Constipation is a very common side effect; advise patients on dietary fiber, fluids, and potential use of stool softeners.
  • Always check for concomitant use of beta-blockers, digoxin, or other AV nodal blocking agents, as this significantly increases the risk of bradycardia and AV block.
  • Grapefruit juice interaction is clinically significant and should be strongly advised against.
  • Monitor for signs of heart failure exacerbation, especially in patients with pre-existing left ventricular dysfunction.
  • For patients with hepatic impairment, significant dose reduction is necessary due to extensive first-pass metabolism.
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Alternative Therapies

  • Other non-dihydropyridine calcium channel blockers (e.g., diltiazem)
  • Dihydropyridine calcium channel blockers (e.g., amlodipine, nifedipine)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • Loop diuretics (e.g., furosemide)
  • Other antiarrhythmics (e.g., digoxin, amiodarone for rate control in AFib)
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Cost & Coverage

Average Cost: $30 - $150 per 30 capsules (generic Verapamil ER 300mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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 this 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 occurred.