Verapamil 120mg ER Capsules

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, as well as cells of the cardiac conduction system (SA and AV nodes). This leads to: 1) Dilation of coronary and peripheral arteries, reducing afterload and improving myocardial oxygen supply. 2) Reduction in myocardial contractility (negative inotropic effect). 3) Slowing of SA node automaticity and AV node conduction, leading to decreased heart rate and prolonged PR interval.

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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

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.

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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Heart failure (a weak heart)
+ Specific types of abnormal heart rhythms, such as 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 problems with your doctor and pharmacist. They will help determine if it is safe for you 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.

Important Warnings and Cautions

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, stand up slowly after sitting or lying down, 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 your alcohol consumption with your doctor before drinking. If you regularly drink grapefruit juice or eat grapefruit, also talk to your doctor about potential interactions.

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.

• Intravenous beta-blockers (risk of severe bradycardia, asystole, AV block, heart failure)
• Disopyramide (additive negative inotropic effects, severe hypotension)
• Dantrolene (risk of malignant hyperthermia-like reaction)
• Ivabradine (additive bradycardia)

• Digoxin (increases digoxin levels, risk of toxicity)
• Statins (e.g., simvastatin, lovastatin - verapamil inhibits CYP3A4, increasing statin levels and risk of myopathy/rhabdomyolysis)
• Amiodarone (risk of severe bradycardia, AV block, hypotension)
• Fentanyl (severe hypotension, bradycardia)
• Clonidine (risk of severe AV block, bradycardia)
• Quinidine (hypotension, pulmonary edema)
• Theophylline (increases theophylline levels)
• Carbamazepine (increases carbamazepine levels, toxicity)
• Cyclosporine, Tacrolimus, Sirolimus, Everolimus (increases immunosuppressant levels, toxicity)
• Alpha-blockers (e.g., prazosin - additive hypotensive effects)
• Other antihypertensives (additive hypotensive effects)
• Grapefruit juice (increases verapamil levels)

• Beta-blockers (oral - risk of bradycardia, AV block, heart failure; monitor closely)
• Cimetidine (increases verapamil levels)
• Rifampin (decreases verapamil levels)
• Phenobarbital, Phenytoin (decreases verapamil levels)
• Lithium (neurotoxicity)
• Midazolam, Triazolam (increases benzodiazepine levels)
• Colchicine (increases colchicine levels, toxicity)
• Dabigatran (increases dabigatran levels, bleeding risk)
• Sulfonylureas (may mask hypoglycemia symptoms)

• Aspirin (may increase bleeding risk with high doses)
• NSAIDs (may reduce antihypertensive effect)

• Dizziness
• Lightheadedness
• Fatigue
• Headache
• Constipation
• Swelling of ankles/feet (peripheral edema)
• Shortness of breath
• Chest pain (worsening angina)
• Palpitations
• Fainting spells

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.

Verapamil is excreted into breast milk. While the amount is small, the potential for adverse effects on the infant (e.g., bradycardia, hypotension) exists. Use with caution; monitor breastfed infant for adverse effects. L3 (moderately safe).

Safety and efficacy of extended-release verapamil in pediatric patients have not been established for hypertension or angina. Immediate-release verapamil is used for certain supraventricular tachyarrhythmias in children under specialist supervision, but its use is generally avoided in infants due to risk of severe hypotension and cardiac arrest.

Elderly patients may be more sensitive to the hypotensive and bradycardic effects of verapamil due to age-related decreases in hepatic and renal function. A lower initial dose (e.g., 120 mg ER) and slower titration are recommended. Monitor closely for adverse effects.

• Verapamil is a non-dihydropyridine CCB, distinct from drugs like amlodipine. It has significant effects on heart rate and AV conduction, unlike dihydropyridines.
• Common and often bothersome side effect is constipation; advise patients on dietary fiber and fluid intake.
• Contraindicated in patients with severe left ventricular dysfunction, sick sinus syndrome (without a pacemaker), 2nd or 3rd degree AV block (without a pacemaker), and in combination with IV beta-blockers.
• Extended-release formulations are designed for once-daily dosing and should not be crushed or chewed.
• Grapefruit juice significantly increases verapamil levels; advise patients to avoid it.
• Monitor for signs of heart failure, especially in patients with pre-existing cardiac conditions.

• Other calcium channel blockers (e.g., Diltiazem for non-dihydropyridine effects; Amlodipine, Nifedipine for dihydropyridine effects)
• 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)
• Loop diuretics (e.g., Furosemide) for heart failure with fluid overload
• Nitrates (for angina)

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 taken, the amount, and the time it happened.