Verapamil ER 100mg Caps PM (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
Non-dihydropyridine Calcium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Sep 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Verapamil is a medication that helps lower high blood pressure and treat certain types of chest pain (angina) or irregular heartbeats. It works by relaxing blood vessels so blood can flow more easily, and by slowing down your heart rate. The 'ER' means extended-release, so it works over 24 hours, and 'PM' means it's designed to be taken in the evening.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Some products should be taken at bedtime, while others can be taken at any time. If you're unsure about the best time 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, and do not mix it with hot applesauce.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment as prescribed.

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. Ensure that all medications are stored in a secure location, out of the reach of children and pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local 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 the capsule whole; do not crush, chew, or divide it.
  • Take the 'PM' formulation in the evening, preferably with food.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the drug's effects and side effects.
  • Maintain a healthy diet, limit sodium intake, and engage in regular physical activity as advised by your doctor.
  • Limit alcohol consumption, as it can further lower blood pressure.
  • Monitor your blood pressure and heart rate regularly at home as instructed by your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg once daily in the evening (for PM formulation)
Dose Range: 100 - 400 mg

Condition-Specific Dosing:

hypertension: Initial dose typically 100 mg to 200 mg once daily in the evening. May titrate up to 400 mg once daily based on response.
angina: Initial dose typically 100 mg to 200 mg once daily in the evening. May titrate up to 400 mg once daily based on response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (limited off-label use for specific arrhythmias, highly individualized)
Child: Not established (limited off-label use for specific arrhythmias, highly individualized)
Adolescent: Not established (limited off-label use for specific arrhythmias, highly individualized)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for adverse effects.
Moderate: No specific adjustment, monitor for adverse effects.
Severe: Use with caution, consider lower initial doses and careful titration due to potential for accumulation. Not dialyzable.
Dialysis: Not significantly removed by hemodialysis. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 20-30% of usual dose) and careful titration.
Moderate: Consider lower initial doses (e.g., 20-30% of usual dose) and careful titration.
Severe: Contraindicated in severe hepatic impairment due to extensive first-pass metabolism and risk of accumulation.

Pharmacology

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Mechanism of Action

Verapamil is a non-dihydropyridine calcium channel blocker that inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells. This leads to: 1) Dilation of coronary and peripheral arteries, reducing systemic vascular resistance and afterload, thus lowering blood pressure. 2) Reduction in myocardial contractility. 3) Slowing of conduction through the SA and AV nodes, leading to decreased heart rate and prolonged PR interval. These actions contribute to its antihypertensive, antianginal, and antiarrhythmic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 20-35% (due to extensive first-pass metabolism)
Tmax: 5-12 hours (for extended-release formulations)
FoodEffect: Food may slightly increase bioavailability and reduce peak plasma concentrations, but generally does not significantly alter overall absorption. Taking with food may reduce GI upset.

Distribution:

Vd: 1.8-5 L/kg
ProteinBinding: Approximately 90%
CnssPenetration: Limited

Elimination:

HalfLife: 5-12 hours (can be prolonged with chronic dosing or hepatic impairment)
Clearance: Approximately 0.5-1.5 L/kg/hr
ExcretionRoute: Approximately 70% renal, 16% fecal
Unchanged: <4% (renal)
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Pharmacodynamics

OnsetOfAction: Several hours (for extended-release formulations)
PeakEffect: 5-12 hours (for extended-release formulations)
DurationOfAction: 24 hours (for 24-hour extended-release formulations)
Confidence: High

Safety & Warnings

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Side Effects

Serious 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
Abnormal heartbeat that is new or worsening
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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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, lightheadedness, or fainting spells.
  • Heart rate consistently below 50 beats per minute (or as advised by your doctor).
  • New or worsening swelling in your ankles, feet, or legs.
  • Difficulty breathing or shortness of breath.
  • Severe or persistent constipation.
  • 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:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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
+ Disopyramide or flibanserin, if taken 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 medications and health conditions. 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, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

Follow your doctor's instructions for monitoring your blood pressure and heart rate, and undergo blood tests as recommended. Discuss any concerns or questions with your doctor.

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.

Discuss alcohol consumption with your doctor before drinking. Additionally, if you regularly consume 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 to discuss the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

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

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • Intravenous beta-blockers (concurrent use or within a few hours)
  • Severe left ventricular dysfunction
  • Sick sinus syndrome (unless a functional pacemaker is present)
  • Second- or third-degree AV block (unless a functional pacemaker is present)
  • Cardiogenic shock
  • Accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) with atrial flutter or atrial fibrillation
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Major Interactions

  • Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia, AV block, hypotension, and heart failure.
  • Digoxin: Verapamil increases serum digoxin levels (reduce digoxin dose by 50%).
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Verapamil is a CYP3A4 inhibitor, increasing statin levels and risk of myopathy/rhabdomyolysis. Use lower statin doses or alternative statins (e.g., pravastatin, rosuvastatin).
  • Amiodarone: Increased risk of bradycardia, AV block, and hypotension.
  • Grapefruit juice: Increases verapamil plasma concentrations due to CYP3A4 inhibition, increasing risk of adverse effects.
  • Dabigatran: Verapamil is a P-gp inhibitor, increasing dabigatran exposure. Dose adjustment of dabigatran may be needed.
  • Fentanyl: Increased risk of severe bradycardia and hypotension.
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Moderate Interactions

  • Other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics): Additive hypotensive effects.
  • Cyclosporine, Tacrolimus, Everolimus, Sirolimus: Verapamil increases levels of these immunosuppressants (CYP3A4 inhibition). Monitor levels and adjust dose.
  • Carbamazepine: Verapamil increases carbamazepine levels, increasing risk of toxicity.
  • Rifampin: Decreases verapamil plasma concentrations (CYP3A4 induction), reducing efficacy.
  • Theophylline: Verapamil may increase theophylline levels.
  • Clonidine: Increased risk of AV block and bradycardia.
  • Quinidine: May increase quinidine levels and risk of hypotension.
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Minor Interactions

  • Cimetidine: May increase verapamil levels.
  • Lithium: May increase lithium levels.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

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

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) and PR interval.

Timing: Prior to initiation

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function (SCr, BUN)

Rationale: To assess baseline kidney function, though renal elimination is minor, severe impairment requires caution.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: Individualized based on treatment goals (e.g., <130/80 mmHg for most adults)

Action Threshold: Persistent hypotension (<90/60 mmHg) or inadequate BP control.

Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: Typically >50-60 bpm (unless target is lower for specific arrhythmias)

Action Threshold: Persistent bradycardia (<50 bpm) or symptomatic bradycardia.

Electrocardiogram (ECG)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)

Target: Normal sinus rhythm, PR interval <0.20 seconds

Action Threshold: Significant prolongation of PR interval (>0.24 seconds), new onset AV block, or other arrhythmias.

Symptoms of Peripheral Edema

Frequency: At each visit

Target: Absence of significant edema

Action Threshold: Development of significant or bothersome lower extremity edema.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Fainting (syncope)
  • Slow heart rate (bradycardia)
  • Shortness of breath or difficulty breathing
  • Swelling in ankles, feet, or legs (peripheral edema)
  • Chest pain (if angina is not controlled)
  • Constipation
  • Fatigue or weakness

Special Patient Groups

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Pregnancy

Verapamil is classified as 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 cause fetal bradycardia.
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Lactation

Verapamil is excreted into breast milk in small amounts (Lactation Risk Category L3 - Moderately Safe). While the amount is generally considered low, monitor breastfed infants for signs of adverse effects such as bradycardia, hypotension, or sedation. Use with caution, especially in neonates or preterm infants.

Infant Risk: Low to moderate risk; monitor infant for bradycardia, hypotension, and sedation.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for hypertension or angina. Limited off-label use for certain supraventricular tachyarrhythmias, but generally not a first-line agent due to risk of severe adverse effects (e.g., profound hypotension, bradycardia, asystole), especially in infants. Dosing is highly individualized and requires expert supervision.

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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 renal and hepatic function, and increased sensitivity of the cardiovascular system. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Verapamil ER PM formulations are designed for once-daily evening dosing to provide 24-hour blood pressure control, particularly targeting morning blood pressure surge.
  • Instruct patients not to crush, chew, or divide extended-release capsules, as this can lead to rapid release of the drug and potential toxicity.
  • Constipation is a very common side effect; advise patients on dietary fiber, fluid intake, and potential use of stool softeners.
  • Avoid concomitant use with grapefruit juice due to significant pharmacokinetic interaction leading to increased verapamil levels.
  • Exercise extreme caution when co-administering with beta-blockers, digoxin, or amiodarone due to additive effects on heart rate and AV conduction.
  • Monitor for signs of heart failure exacerbation, especially in patients with pre-existing left ventricular dysfunction.
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Alternative Therapies

  • Other non-dihydropyridine calcium channel blockers (e.g., diltiazem extended-release)
  • Dihydropyridine calcium channel blockers (e.g., amlodipine, nifedipine ER, felodipine) for hypertension/angina
  • Beta-blockers (e.g., metoprolol, carvedilol) for hypertension, angina, or rate control in arrhythmias
  • ACE inhibitors (e.g., lisinopril, enalapril) for hypertension
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan) for hypertension
  • Diuretics (e.g., hydrochlorothiazide, furosemide) for hypertension or fluid management
  • Other antiarrhythmics (e.g., flecainide, propafenone, sotalol, amiodarone) for specific arrhythmias
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (generic 100mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.