Verapamil ER 300mg Capsules

Manufacturer WILSHIRE PHARMACEUTICALS 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
Calcium Channel Blocker, Antiarrhythmic, Antihypertensive
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Pharmacologic Class
Non-dihydropyridine Calcium Channel Blocker
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Pregnancy Category
C
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FDA Approved
Mar 1989
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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 can lower your blood pressure, help with chest pain (angina), and control certain irregular heart rhythms. The ER (extended-release) capsule is designed to release the medicine slowly over time, so you usually take it only 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 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. 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, away from direct light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Ensure that all medications are kept 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 way to dispose of your medication. 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 medication at the same time each day, preferably with food to reduce stomach upset.
  • Swallow the extended-release capsules whole; do not crush, chew, or break them.
  • Avoid consuming grapefruit or 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 and cause dizziness.
  • Maintain a healthy diet, exercise regularly, and manage stress as part of a comprehensive plan for blood pressure or heart condition management.
  • 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: Hypertension: 180-480 mg once daily (ER formulation). Angina: 180-480 mg once daily (ER formulation).
Dose Range: 180 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180 mg once daily; titrate up to 480 mg once daily.
angina: Initial: 180 mg once daily; titrate up to 480 mg once daily.
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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, monitor for adverse effects. Consider lower initial doses.
Dialysis: Verapamil is not removed by hemodialysis. No supplemental dose needed.

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 120 mg ER).
Moderate: Reduce dose by 70-80% (e.g., 60-120 mg ER initially). Titrate carefully.
Severe: Contraindicated or use with extreme caution and significant dose reduction (e.g., 60 mg ER initially), due to extensive hepatic metabolism.

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 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: ER: 7-9 hours
FoodEffect: Food does not significantly affect the absorption of extended-release formulations.

Distribution:

Vd: 1.8-5.5 L/kg
ProteinBinding: 90%
CnssPenetration: Limited

Elimination:

HalfLife: ER: 4.5-12 hours (single dose); 8-15 hours (multiple doses)
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: 70% renal, 16% fecal
Unchanged: 3-4% (renal)
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Pharmacodynamics

OnsetOfAction: Oral: 1-2 hours
PeakEffect: ER: 7-9 hours
DurationOfAction: ER: 24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 attention immediately:

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. 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 about side effects, 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.
  • Slow heart rate (pulse below 50 beats per minute).
  • New or worsening swelling in your hands, ankles, or feet.
  • Difficulty breathing or shortness of breath.
  • Unusual fatigue or weakness.
  • Severe constipation that is new or worsening.
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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 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
+ 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions. 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.

As directed by your doctor, regularly monitor your blood pressure and heart rate, and undergo blood tests as scheduled. Discuss any concerns or questions with your doctor.

If you have high blood pressure and are taking this medication, 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. 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 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)
  • Bradycardia (very slow heart rate)
  • Asystole (cardiac arrest)
  • AV block (heart block)
  • 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

  • Intravenous beta-blockers (concurrent use or within a few hours)
  • Disopyramide (within 48 hours before or 24 hours after verapamil)
  • Dantrolene (IV)
  • Ivabradine
  • Patients with severe left ventricular dysfunction, hypotension (<90 mmHg systolic), cardiogenic shock, sick sinus syndrome (unless pacemaker in place), second- or third-degree AV block (unless pacemaker in place), atrial flutter/fibrillation with an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes).
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Major Interactions

  • Digoxin (increases digoxin levels, monitor for toxicity)
  • Statins (e.g., simvastatin, lovastatin, atorvastatin - increases statin levels, risk of myopathy/rhabdomyolysis)
  • Amiodarone (increased risk of bradycardia, AV block, hypotension)
  • Flecainide (additive negative inotropic and chronotropic effects)
  • Quinidine (hypotension, AV block)
  • Grapefruit juice (increases verapamil levels)
  • Clonidine (increased risk of AV block)
  • Rifampin (decreases verapamil levels)
  • Phenobarbital (decreases verapamil levels)
  • Carbamazepine (increases carbamazepine levels, risk of toxicity)
  • Cyclosporine (increases cyclosporine levels)
  • Theophylline (increases theophylline levels)
  • Buspirone (increases buspirone levels)
  • Midazolam/Triazolam (increases benzodiazepine levels)
  • Erythromycin/Clarithromycin (may increase verapamil levels)
  • Ritonavir/other protease inhibitors (may increase verapamil levels)
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Moderate Interactions

  • Beta-blockers (oral - increased risk of bradycardia, AV block, hypotension, heart failure; use with caution)
  • Alpha-blockers (e.g., prazosin - increased risk of hypotension)
  • Lithium (neurotoxicity)
  • Cimetidine (may increase verapamil levels)
  • Phenytoin (may decrease verapamil levels)
  • Sulfinpyrazone (may decrease verapamil levels)
  • Neuromuscular blockers (potentiates effects)
  • Aspirin (increased bleeding risk with high doses)
  • Ethanol (prolongs elimination of ethanol)
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Minor Interactions

  • Not available (most interactions are moderate to major due to CYP3A4 inhibition and pharmacodynamic effects)

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 risk of bradycardia.

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 in patients with suspected hepatic impairment.

Timing: Prior to initiation (if clinically indicated)

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, though dose adjustment is less critical than for hepatic impairment.

Timing: Prior to initiation (if clinically indicated)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

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

Action Threshold: Hypotension (e.g., systolic <90 mmHg or symptomatic hypotension); inadequate BP control.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Typically >50-60 bpm (unless otherwise clinically indicated).

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

Electrocardiogram (ECG)

Frequency: Periodically, especially with dose increases or in patients with underlying cardiac conditions or concomitant medications affecting conduction.

Target: Normal sinus rhythm, PR interval <0.20 seconds.

Action Threshold: Significant PR prolongation, new or worsening AV block, other arrhythmias.

Signs/Symptoms of Heart Failure (e.g., edema, dyspnea, weight gain)

Frequency: Regularly, at each visit.

Target: Absence of new or worsening signs/symptoms.

Action Threshold: Development or worsening of heart failure symptoms.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Fatigue
  • Swelling in ankles/feet (edema)
  • Shortness of breath
  • Chest pain (if angina not controlled)
  • Constipation (common side effect)
  • Headache

Special Patient Groups

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Pregnancy

Verapamil is Pregnancy Category C. Studies in animals 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 fetal harm based on animal studies; human data limited.
Second Trimester: Potential for fetal harm based on animal studies; human data limited.
Third Trimester: Potential for fetal harm based on animal studies; human data limited. May inhibit uterine contractions.
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Lactation

Verapamil is excreted in human milk. The American Academy of Pediatrics considers it compatible with breastfeeding. However, monitor the infant for potential adverse effects such as bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor infant for bradycardia, hypotension, and sedation. Consider alternative if infant is premature or has underlying cardiac issues.
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Pediatric Use

Safety and effectiveness of extended-release verapamil in pediatric patients have not been established. Use is generally not recommended for routine management of hypertension or angina in children.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive and bradycardic effects of verapamil due to decreased hepatic metabolism and renal clearance. Start with lower doses (e.g., 120 mg ER) and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Verapamil ER is a non-dihydropyridine calcium channel blocker, distinct from dihydropyridines (e.g., amlodipine) due to its significant effects on heart rate and AV nodal conduction.
  • It is effective for hypertension, chronic stable angina, and certain supraventricular tachyarrhythmias (though ER is less suitable for acute arrhythmias).
  • Constipation is a very common side effect; advise patients on dietary fiber and fluid intake.
  • Avoid grapefruit juice due to significant CYP3A4 interaction, which can lead to increased verapamil levels and toxicity.
  • Exercise extreme caution when co-administering with beta-blockers, especially IV, due to additive negative chronotropic and inotropic effects, increasing risk of severe bradycardia, AV block, and heart failure.
  • Dose adjustments are crucial in patients with hepatic impairment due to extensive first-pass metabolism.
  • Patients should be advised not to crush or chew ER capsules, as this can lead to rapid release and potential toxicity.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Dihydropyridines like Amlodipine, Felodipine for hypertension/angina; Diltiazem for similar indications as verapamil)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Nitrates (for angina)
  • Antiarrhythmics (e.g., Diltiazem, Beta-blockers, Digoxin for rate control in AF)
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Cost & Coverage

Average Cost: $30 - $150 per 30 capsules (300mg ER)
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 overdose, including the medication taken, the amount, and the time it occurred.