Propranolol ER 120mg Capsules

Manufacturer ACTAVIS Active Ingredient Propranolol Sustained-Release Capsules(proe PRAN oh lole) Pronunciation proe PRAN oh lole
It is used to treat high blood pressure.It is used to treat chest pain or pressure. It is used to help certain heart problems.It is used to prevent migraine headaches.
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Drug Class
Antihypertensive, Antiarrhythmic, Antianginal, Migraine Prophylaxis
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Pharmacologic Class
Non-selective beta-adrenergic blocker
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Pregnancy Category
C
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FDA Approved
Sep 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol ER is a type of medicine called a beta-blocker. It works by relaxing blood vessels and slowing down your heart rate, which helps to lower high blood pressure, prevent chest pain (angina), and reduce the frequency of migraine headaches. The 'ER' means Extended Release, so you usually take it once a day.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications must be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
When taking this medication in capsule form, swallow the capsule whole. Do not chew, break, or crush it, as this can affect the way the medication works.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. Stopping your medication without consulting your doctor can affect its effectiveness.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store your medication at room temperature, away from extreme heat, cold, and light.
Keep the container tightly closed to prevent moisture and other environmental factors from affecting the medication.
Do not freeze your medication, as this can alter its composition and effectiveness.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
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 a missed dose, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Continue to follow a heart-healthy diet (low in salt, saturated fat, cholesterol).
  • Engage in regular physical activity as advised by your doctor.
  • Limit alcohol intake.
  • Avoid smoking.
  • Manage stress effectively.
  • 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: For hypertension, 80-160 mg once daily. For angina pectoris or migraine prophylaxis, 160 mg once daily.
Dose Range: 80 - 320 mg

Condition-Specific Dosing:

hypertension: 80-160 mg once daily; may increase to 120-160 mg once daily for optimal response.
anginaPectoris: 160 mg once daily.
migraineProphylaxis: 160 mg once daily.
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Pediatric Dosing

Neonatal: Not established for ER formulation.
Infant: Not established for ER formulation.
Child: Not established for ER formulation; immediate-release formulation used for specific indications (e.g., infantile hemangioma, hypertension) with weight-based dosing.
Adolescent: Not established for ER formulation; immediate-release formulation used for specific indications.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically required.
Moderate: No dosage adjustment typically required.
Severe: Use with caution; monitor for exaggerated effects. Accumulation of active metabolites may occur, though renal excretion of parent drug is minor.
Dialysis: Not significantly removed by hemodialysis. No specific supplemental dose needed, but monitor for effects.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant dosage reduction required (e.g., 50% or more of usual dose). Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution and significant dosage reduction (e.g., 75% or more of usual dose). Propranolol is extensively metabolized by the liver.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks beta-1 (myocardial) and beta-2 (bronchial and vascular smooth muscle) adrenergic receptors. This results in decreased heart rate, myocardial contractility, and cardiac output, leading to reduced blood pressure. It also inhibits renin release from the kidneys. For migraine prophylaxis, its mechanism is not fully understood but may involve modulation of cerebral blood flow and neurotransmitter release.
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Pharmacokinetics

Absorption:

Bioavailability: 11-60% (highly variable due to extensive first-pass metabolism)
Tmax: 6 hours (for ER formulation)
FoodEffect: Food may increase bioavailability and reduce variability, but ER formulation can be taken with or without food.

Distribution:

Vd: 4 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes (lipophilic, readily crosses blood-brain barrier)

Elimination:

HalfLife: 3-6 hours (elimination half-life of parent drug); effective half-life for ER formulation is longer, allowing once-daily dosing.
Clearance: 0.16-0.36 L/hr/kg
ExcretionRoute: Renal (primarily as metabolites, <1% unchanged drug)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for ER, initial effects may be slower than IR)
PeakEffect: 6-12 hours (for ER)
DurationOfAction: 24 hours (for ER formulation)

Safety & Warnings

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BLACK BOX WARNING

Abrupt discontinuation of beta-blockers, including propranolol, should be avoided, especially in patients with ischemic heart disease. Exacerbation of angina pectoris, myocardial infarction, and ventricular arrhythmias have occurred following abrupt cessation. When discontinuing chronically administered propranolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient carefully monitored. If angina worsens or acute coronary insufficiency develops, propranolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy
+ Weakness, shaking, or rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburning
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Severe dizziness or fainting
New or worsening chest pain
Slow or irregular heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion or hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or other mood changes
Abnormal burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red) or eyesight
Unexplained bruising or bleeding
Fever, chills, or sore throat
Erectile dysfunction
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, such as red, swollen, blistered, or peeling skin; skin irritation (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes

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, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, drowsiness, tiredness, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Sleep disturbances
* Vivid or unusual dreams

Reporting 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:

  • Very slow heart rate (less than 50 beats per minute)
  • Dizziness or lightheadedness, especially when standing up
  • Shortness of breath, wheezing, or difficulty breathing (especially if you have asthma or COPD)
  • Swelling in your ankles or feet, unusual weight gain (signs of heart failure)
  • New or worsening chest pain (if you stop the medication suddenly)
  • Coldness, numbness, or tingling in your fingers or toes
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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, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain heart conditions, including:
+ Abnormal heart rhythms (heart block or sick-sinus syndrome)
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory issues, such as:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history

To ensure your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

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 understand how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Monitoring and Lab Tests
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Be aware that this medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

Interactions with Other Substances
Discuss alcohol consumption with your doctor before drinking. If you smoke, talk to your doctor about the potential risks. This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, especially in people with diabetes, children, and those who are fasting or have undergone surgery.

Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.

Stopping the Medication
Do not abruptly stop taking this medication, as this can lead to worsened chest pain or even heart attack, especially in individuals with certain types of heart disease. To avoid side effects, your doctor will guide you on how to gradually discontinue the medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Thyroid Conditions
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult your doctor for guidance.

Interactions with Other Medications
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.

Allergic Reactions
If you have a history of severe allergic reactions, discuss this with your doctor, as you may be at risk of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Severe hypotension (very low blood pressure)
  • Cardiogenic shock
  • Heart failure
  • Bronchospasm (difficulty breathing)
  • Hypoglycemia (low blood sugar)
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include atropine for bradycardia, glucagon, vasopressors, and intravenous fluids.

Drug Interactions

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Contraindicated Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) in patients with severe left ventricular dysfunction or AV conduction abnormalities (risk of severe bradycardia, heart block, heart failure).
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Major Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May significantly increase propranolol plasma concentrations, leading to increased beta-blockade and adverse effects.
  • Other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics): Additive hypotensive effects.
  • Clonidine: Abrupt withdrawal of clonidine while on propranolol can lead to severe rebound hypertension. Propranolol should be discontinued several days before gradual withdrawal of clonidine.
  • Insulin and oral hypoglycemics: Beta-blockers can mask symptoms of hypoglycemia (e.g., tremor, tachycardia) and prolong hypoglycemic episodes.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of propranolol.
  • Alpha-1 adrenergic blockers (e.g., prazosin, doxazosin): May cause additive hypotensive effects, especially orthostatic hypotension.
  • Digoxin: May cause additive bradycardia.
  • Sympathomimetics (e.g., epinephrine, norepinephrine): May cause unopposed alpha-adrenergic stimulation, leading to severe hypertension and bradycardia.
  • Cimetidine, Hydralazine: May increase propranolol levels.
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Minor Interactions

  • Aluminum hydroxide gel: May decrease propranolol absorption.

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, a common side effect.

Timing: Prior to initiation.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block).

Timing: Prior to initiation, especially in patients with cardiac history.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, though renal adjustment is usually not needed, severe impairment warrants caution.

Timing: Prior to initiation.

Hepatic Function (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, as propranolol is extensively metabolized by the liver.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly, then every 3-6 months).

Target: Individualized, typically <130/80 mmHg for hypertension.

Action Threshold: If persistently high, consider dose adjustment; if too low (e.g., symptomatic hypotension), consider dose reduction.

Heart Rate (HR)

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

Target: Typically >50-60 bpm (unless specific therapeutic goal for lower HR).

Action Threshold: If <50 bpm or symptomatic bradycardia, consider dose reduction or discontinuation.

Symptoms of Heart Failure

Frequency: Periodically, especially in patients with underlying cardiac disease.

Target: Absence of new or worsening symptoms.

Action Threshold: If new or worsening dyspnea, edema, or fatigue, evaluate for heart failure exacerbation.

Blood Glucose (in diabetic patients)

Frequency: More frequent monitoring, especially during initiation or dose changes.

Target: Individualized.

Action Threshold: If unexplained hypoglycemia or difficulty recognizing symptoms, adjust diabetes regimen or consider alternative antihypertensive.

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, weakness
  • Shortness of breath, wheezing (especially in patients with asthma/COPD)
  • Cold hands and feet
  • Depression, sleep disturbances
  • Exacerbation of angina or arrhythmias upon abrupt discontinuation

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Propranolol crosses the placenta.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and growth restriction. Monitor neonate for signs of beta-blockade for several days after birth.
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Lactation

L3 (Moderately Safe). Propranolol is excreted into breast milk in small amounts. Monitor breastfed infant for signs of beta-blockade.

Infant Risk: Low to moderate risk. Potential for bradycardia, hypotension, and hypoglycemia in the infant, especially in preterm or neonates with impaired renal function. Observe infant for signs of adverse effects.
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Pediatric Use

Propranolol ER is generally not recommended for pediatric use due to lack of established safety and efficacy. Immediate-release propranolol is used off-label for specific pediatric conditions (e.g., infantile hemangioma, hypertension, certain arrhythmias) with careful weight-based dosing and monitoring.

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Geriatric Use

Geriatric patients may be more sensitive to the effects of beta-blockers and may have reduced hepatic clearance, leading to higher plasma concentrations. Initiate therapy with lower doses and titrate slowly. Monitor closely for bradycardia, hypotension, and CNS effects (e.g., confusion, depression).

Clinical Information

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Clinical Pearls

  • Propranolol ER is taken once daily, ideally at the same time each day, to maintain consistent drug levels.
  • Do not crush, chew, or open the extended-release capsules; they must be swallowed whole.
  • Patients with a history of asthma, severe COPD, or other bronchospastic diseases should generally avoid propranolol due to its non-selective beta-blocking effects.
  • Use with extreme caution in patients with diabetes, as it can mask symptoms of hypoglycemia and prolong hypoglycemic episodes.
  • Patients should be advised not to abruptly discontinue propranolol due to the risk of rebound hypertension, angina exacerbation, or myocardial infarction.
  • Can cause cold extremities due to peripheral vasoconstriction.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol)
  • Calcium channel blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Alpha-1 blockers (e.g., prazosin, doxazosin)
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 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 taken, the amount, and the time it occurred.