Verapamil 360mg SR Capsules

Manufacturer ACTAVIS 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, Antianginal, Antiarrhythmic
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Pharmacologic Class
Calcium Channel Blocker, Non-dihydropyridine
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Pregnancy 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 helps lower high blood pressure, reduce chest pain (angina), and control certain irregular heartbeats. It's a sustained-release capsule, meaning it releases the medicine slowly over time, so you usually 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, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your medication 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 directed by your doctor or healthcare provider, even if you start to feel 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. 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 for safe and responsible disposal.

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, regular exercise, and manage stress to support blood pressure control.
  • 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 mg to 480 mg once daily (SR formulation). For 360mg SR, typically 360 mg once daily.
Dose Range: 180 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180 mg SR once daily. May titrate up to 360-480 mg SR once daily. Max: 480 mg/day.
angina: Initial: 180 mg SR once daily. May titrate up to 360-480 mg SR once daily. Max: 480 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for SR capsules; immediate-release formulations or IV may be used for specific indications under specialist supervision.
Adolescent: Not established for SR capsules; immediate-release formulations or IV may be used for specific indications under specialist supervision.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically required.
Moderate: No dosage adjustment typically required, but 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 SR once daily) and titrate slowly.
Moderate: Reduce dose by 70-80% (e.g., 60-120 mg SR once daily) and titrate slowly. Monitor closely.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism and high first-pass effect.

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 a reduction in myocardial contractility, slowing of AV nodal conduction, and vasodilation of coronary and peripheral arteries. These actions result in decreased myocardial oxygen demand, increased coronary blood flow, and reduced systemic vascular resistance, leading to blood pressure reduction.
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Pharmacokinetics

Absorption:

Bioavailability: 20-35% (due to extensive first-pass metabolism)
Tmax: SR: 7-9 hours (range 4-12 hours)
FoodEffect: Food does not significantly affect the bioavailability of sustained-release formulations, but may slightly delay Tmax.

Distribution:

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

Elimination:

HalfLife: SR: 7-20 hours (single dose); 12-24 hours (multiple doses)
Clearance: 0.5-1.0 L/kg/hr
ExcretionRoute: 70% renal (as metabolites), 16% fecal (as metabolites)
Unchanged: 3-4% (renal)
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Pharmacodynamics

OnsetOfAction: SR: 2-5 hours
PeakEffect: SR: 7-9 hours
DurationOfAction: SR: 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 immediate medical attention:

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 about side effects, contact your doctor for medical advice. 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
  • Very slow heartbeat (less than 50 beats per minute)
  • Shortness of breath or swelling in your ankles/feet (signs of heart failure)
  • Severe constipation that doesn't improve with diet/fiber
  • Unusual tiredness or weakness
  • Yellowing of skin or eyes (jaundice)
  • Severe headache that is new or worse
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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 problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor, and discuss the results with them.

Interactions with Other Medications and Substances
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
- Certain natural products or aids

Alcohol and Grapefruit Consumption
Discuss with your doctor before consuming alcohol or if you regularly drink grapefruit juice or eat grapefruit.

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

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need 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 (very 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

  • Ivabradine (risk of severe bradycardia)
  • Dantrolene (IV) (risk of cardiovascular collapse)
  • Disopyramide (within 48 hours of verapamil, risk of severe hypotension and asystole)
  • Flecainide (risk of severe myocardial depression and AV block)
  • Quinidine (in patients with hypertrophic cardiomyopathy, risk of severe hypotension and pulmonary edema)
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Major Interactions

  • Beta-blockers (e.g., metoprolol, carvedilol) - increased risk of bradycardia, AV block, heart failure
  • Digoxin - increased digoxin levels (reduce digoxin dose by 50%)
  • Amiodarone - increased risk of bradycardia, AV block, hypotension
  • Statins (e.g., simvastatin, lovastatin, atorvastatin) - increased statin levels, risk of myopathy/rhabdomyolysis (due to CYP3A4 inhibition)
  • Cyclosporine, Tacrolimus, Sirolimus, Everolimus - increased immunosuppressant levels (due to CYP3A4/P-gp inhibition)
  • Carbamazepine - increased carbamazepine levels, risk of toxicity
  • Theophylline - increased theophylline levels
  • Clonidine - increased risk of AV block and bradycardia
  • Fentanyl - increased risk of respiratory depression and hypotension
  • Rifampin, Phenobarbital, Phenytoin (CYP3A4 inducers) - decreased verapamil levels
  • Grapefruit juice - increased verapamil levels
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Moderate Interactions

  • Alpha-1 blockers (e.g., prazosin) - additive hypotensive effects
  • Other antihypertensives - additive hypotensive effects
  • Lithium - increased lithium neurotoxicity (rare)
  • Cimetidine - increased verapamil levels
  • Erythromycin, Clarithromycin (CYP3A4 inhibitors) - increased verapamil levels
  • Benzodiazepines (e.g., midazolam, triazolam) - increased benzodiazepine levels
  • Colchicine - increased colchicine levels, risk of toxicity
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Minor Interactions

  • Aspirin - may increase bleeding risk (theoretical)
  • NSAIDs - may reduce antihypertensive effect (theoretical)

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, especially in patients with pre-existing bradycardia or AV conduction abnormalities.

Timing: Prior to initiation.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing AV block or sick sinus syndrome, which are contraindications or require extreme 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, if clinically indicated.

Renal Function (SCr, eGFR)

Rationale: To assess baseline renal function, though dose adjustments are not typically needed for mild-moderate impairment, severe impairment requires caution.

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 (e.g., weekly during titration, then monthly/quarterly).

Target: <130/80 mmHg (or individualized target)

Action Threshold: If BP remains uncontrolled, consider dose increase or add therapy. If BP is too low (<90/60 mmHg or symptomatic hypotension), consider dose reduction.

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: If HR <50 bpm or symptomatic bradycardia, consider dose reduction or discontinuation. If new onset AV block, discontinue.

ECG (PR interval)

Frequency: Periodically, especially with dose increases or in patients with pre-existing conduction abnormalities or concomitant AV nodal blocking agents.

Target: Normal PR interval (<0.20 seconds)

Action Threshold: If PR interval significantly prolongs (>0.24 seconds) or new onset 2nd/3rd degree AV block, consider dose reduction or discontinuation.

Signs/Symptoms of Heart Failure

Frequency: Regularly, especially in patients with impaired left ventricular function.

Target: Absence of worsening dyspnea, edema, fatigue.

Action Threshold: If worsening symptoms, evaluate for heart failure exacerbation; consider discontinuation.

Constipation

Frequency: Regularly, as it is a common side effect.

Target: Regular bowel movements.

Action Threshold: If severe or bothersome, recommend dietary changes, fiber, laxatives, or consider alternative therapy.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Peripheral edema (swelling of ankles/feet)
  • Shortness of breath
  • Chest pain (worsening angina)
  • Palpitations
  • Constipation
  • Nausea

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. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal studies; use only if clearly needed.
Second Trimester: Potential for fetal harm; use with caution.
Third Trimester: Potential for fetal harm; use with caution. May inhibit uterine contractions.
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Lactation

Verapamil is excreted into 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 (Moderately Safe) per LactMed.

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

Safety and efficacy of sustained-release verapamil capsules have not been established in pediatric patients. Immediate-release or IV formulations may be used for specific indications (e.g., supraventricular tachycardia) under specialist supervision, but generally not for chronic hypertension in children.

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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. Monitor closely for adverse effects, especially constipation and orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Verapamil SR is typically taken once daily, often in the morning, but Verelan PM is designed for bedtime dosing to provide morning BP control.
  • Constipation is a very common and often dose-limiting side effect; advise patients on dietary fiber, fluids, and potential use of stool softeners.
  • Always check heart rate and blood pressure before administering, especially during dose titration.
  • Avoid concomitant use with beta-blockers, especially IV, due to increased risk of severe bradycardia, AV block, and heart failure. If co-administration is necessary, monitor closely.
  • Verapamil is a potent CYP3A4 inhibitor and P-glycoprotein inhibitor, leading to numerous significant drug interactions. Review patient's full medication list carefully.
  • Patients with Wolff-Parkinson-White (WPW) syndrome and atrial fibrillation/flutter should NOT receive verapamil due to the risk of accelerating conduction down the accessory pathway, leading to ventricular fibrillation.
  • Not recommended for patients with significant left ventricular dysfunction or overt heart failure due to its negative inotropic effects.
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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, Atenolol)
  • ACE inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Thiazide diuretics (e.g., Hydrochlorothiazide)
  • Alpha-1 blockers (e.g., Prazosin, Doxazosin)
  • Centrally acting alpha-2 agonists (e.g., Clonidine)
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Cost & Coverage

Average Cost: $30 - $150 per 30 capsules (360mg SR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.