Verapamil ER 200mg 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
Non-dihydropyridine Calcium Channel Blocker
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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 your blood pressure, relieve chest pain (angina), and help control certain irregular heart rhythms. The ER (extended-release) capsule is designed to work over 24 hours, so you usually only need to take it once a day.
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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 are designed to 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. Avoid mixing the medication with hot applesauce.

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

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 kept out of 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 at approximately the same time each day.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of verapamil in your body and lead to more side effects.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effects.
  • Maintain a healthy diet (low in sodium, rich in fruits/vegetables), regular exercise, and manage stress to support heart health.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mg orally once daily (for hypertension/angina)
Dose Range: 100 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg ER once daily; adjust based on response, max 480 mg/day.
angina: Initial: 180-240 mg ER once daily; adjust based on response, max 480 mg/day.
supraventricular_tachycardia_prophylaxis: Not typically used for acute treatment; for prophylaxis, similar to angina/hypertension dosing.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (ER formulations generally not recommended)
Adolescent: Not established (ER formulations generally not recommended)
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 120 mg ER once daily) and titrate slowly.
Moderate: Reduce dose significantly (e.g., 30% of normal dose) and monitor closely due to extensive hepatic metabolism.
Severe: Contraindicated or use with extreme caution at significantly reduced doses (e.g., 20-25% of normal dose) and close monitoring.

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 coronary and peripheral vasodilation, reduced myocardial contractility, decreased heart rate, and slowed AV nodal conduction. These actions result in decreased systemic vascular resistance, reduced blood pressure, and improved myocardial oxygen supply/demand balance.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 4.5-12 hours (single dose); 8-15 hours (multiple doses, due to saturation of hepatic enzymes)
Clearance: Not available
ExcretionRoute: 70% renal, 16% fecal
Unchanged: 3-4% (renal)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for ER formulations)
PeakEffect: 5-10 hours (for ER formulations)
DurationOfAction: 24 hours (for 24-hour ER formulations)

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
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 unusual 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 or lightheadedness, especially when standing up
  • Fainting spells
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • New or worsening swelling in your ankles, feet, or legs
  • Shortness of breath, especially at rest or lying down
  • Unusual fatigue or weakness
  • Severe constipation
  • Chest pain that worsens or does not go away
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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 existing treatments and health status. Never start, stop, or change the dose of any medication without 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, 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, and undergo blood tests as recommended. Discuss any concerns or questions with your doctor.

If you have high blood pressure, consult your doctor before taking 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. Additionally, 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 plan 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:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia)
  • Dantrolene (IV) (risk of hyperkalemia and myocardial depression)
  • Disopyramide (within 48 hours of verapamil, risk of severe hypotension and asystole)
  • Flecainide (risk of additive negative inotropic effects)
  • Quinidine (in patients with hypertrophic cardiomyopathy, risk of severe hypotension and pulmonary edema)
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Major Interactions

  • Beta-blockers (e.g., metoprolol, propranolol): Additive negative chronotropic and inotropic effects, risk of severe bradycardia, AV block, heart failure.
  • Digoxin: Verapamil increases digoxin levels (inhibits P-gp), leading to digoxin toxicity.
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Verapamil inhibits CYP3A4, increasing statin levels and risk of myopathy/rhabdomyolysis.
  • Amiodarone: Additive effects on heart rate and AV conduction, risk of severe bradycardia and AV block.
  • Clonidine: Additive effects on heart rate and AV conduction.
  • Fentanyl: Risk of severe hypotension and/or increased respiratory depression.
  • Grapefruit juice: Increases verapamil levels (CYP3A4 inhibition), increasing risk of adverse effects.
  • Rifampin: Decreases verapamil levels (CYP3A4 induction), reducing efficacy.
  • Carbamazepine: Verapamil increases carbamazepine levels, increasing risk of toxicity.
  • Theophylline: Verapamil may increase theophylline levels.
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin): Additive hypotensive effects.
  • Cimetidine: May increase verapamil levels.
  • Lithium: May increase lithium levels, risk of neurotoxicity.
  • Cyclosporine, Tacrolimus, Sirolimus, Everolimus: Verapamil increases levels of these immunosuppressants (CYP3A4/P-gp inhibition).
  • Buspirone: Verapamil may increase buspirone levels.
  • Midazolam, Triazolam: Verapamil increases levels of these benzodiazepines (CYP3A4 inhibition).
  • Sulfinpyrazone: May decrease verapamil levels.
  • Phenobarbital, Phenytoin: May decrease verapamil levels.
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Minor Interactions

  • Aspirin: No significant interaction, but monitor for bleeding if patient has other risk factors.
  • NSAIDs: May reduce antihypertensive effect of verapamil.

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 baseline cardiac rhythm and PR interval, especially in patients with pre-existing conduction abnormalities.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: Verapamil is extensively metabolized by the liver; to assess baseline hepatic function.

Timing: Prior to initiation

Renal Function Tests (Creatinine, BUN)

Rationale: To assess baseline renal function, though renal excretion is minor for unchanged drug.

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: <130/80 mmHg (or individualized target)

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

Heart Rate (HR)

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

Target: 50-90 bpm (or individualized target)

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

Electrocardiogram (ECG)

Frequency: Periodically, especially if symptoms of conduction disturbance or with concomitant drugs affecting AV node.

Target: Normal sinus rhythm, PR interval <0.20 seconds

Action Threshold: Prolonged PR interval, AV block, or other arrhythmias

Symptoms of Heart Failure (e.g., edema, dyspnea)

Frequency: Regularly

Target: Absence of new or worsening symptoms

Action Threshold: Development or worsening of heart failure symptoms

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Swelling of ankles/feet (peripheral edema)
  • Shortness of breath
  • Chest pain (worsening angina)
  • Slow heart rate (bradycardia)
  • Constipation
  • Headache
  • Fatigue

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 cause fetal bradycardia.
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Lactation

Verapamil is excreted into breast milk. While the amount is generally low and adverse effects in breastfed infants are rare, caution is advised. Monitor the infant for bradycardia, hypotension, and sedation.

Infant Risk: Low risk, but monitor for adverse effects.
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Pediatric Use

Safety and effectiveness of Verapamil ER in pediatric patients have not been established. ER formulations are generally not recommended due to lack of data and difficulty in dose titration.

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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. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Verapamil ER is a once-daily formulation, crucial for patient adherence. Ensure patients understand not to crush or chew.
  • Always inquire about grapefruit consumption, as it's a significant interaction.
  • Monitor heart rate and blood pressure closely, especially during initiation and dose adjustments, and when combining with other rate-lowering agents (e.g., beta-blockers, digoxin).
  • Constipation is a very common side effect; advise patients on dietary fiber, fluids, and potential use of stool softeners.
  • Verapamil is contraindicated in patients with severe left ventricular dysfunction, sick sinus syndrome (without a pacemaker), second- or third-degree AV block (without a pacemaker), and severe hypotension.
  • Be cautious when switching from immediate-release to extended-release formulations, ensuring appropriate dose conversion.
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Alternative Therapies

  • Other non-dihydropyridine calcium channel blockers (e.g., Diltiazem ER)
  • Dihydropyridine calcium channel blockers (e.g., Amlodipine, Nifedipine ER)
  • Beta-blockers (e.g., Metoprolol ER, Atenolol)
  • ACE inhibitors (e.g., Lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan)
  • Diuretics (e.g., Hydrochlorothiazide)
  • Other antiarrhythmics (e.g., Digoxin, Amiodarone for rate control in AFib)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 30 capsules (200mg 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'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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.