Propranolol 40mg Tablets

Manufacturer ACTAVIS Active Ingredient Propranolol Tablets(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.It is used to treat tremor (essential).It is used after a heart attack to help prevent future heart attacks and lengthen life.It is used to treat pheochromocytoma. It is used to treat certain types of abnormal heartbeats.
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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
Nov 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a medication called a beta-blocker. It works by relaxing blood vessels and slowing your heart rate, which helps to lower blood pressure, reduce chest pain (angina), prevent migraines, and control tremors. It can also be used for certain heart rhythm problems.
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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 prescription, and follow the instructions closely. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.

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

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from freezing temperatures. Protect the medication from heat, cold, and light, and keep the lid tightly closed.

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

  • Do not stop taking this medication suddenly, especially if you have heart disease. Your doctor will tell you how to slowly reduce the dose over time.
  • Take your blood pressure and heart rate regularly as advised by your doctor and report any significant changes.
  • Avoid alcohol, as it can increase the effects of propranolol.
  • Be cautious when standing up quickly, as you may feel dizzy (orthostatic hypotension).
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • If you have asthma or COPD, be aware that this medication can worsen breathing problems. Report any shortness of breath or wheezing immediately.
  • If you are diabetic, monitor your blood sugar closely, as propranolol can mask the symptoms of low blood sugar.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. E.g., Hypertension: 40 mg twice daily; Angina: 80-320 mg/day in divided doses; Migraine Prophylaxis: 80 mg/day in divided doses, up to 240 mg/day.
Dose Range: 10 - 640 mg

Condition-Specific Dosing:

Hypertension: Initial 40 mg twice daily, maintenance 120-240 mg/day.
Angina Pectoris: Initial 80 mg/day in divided doses, maintenance 160-320 mg/day.
Migraine Prophylaxis: Initial 80 mg/day in divided doses, maintenance 160-240 mg/day.
Essential Tremor: Initial 40 mg twice daily, maintenance 120-320 mg/day.
Arrhythmias: 10-30 mg three or four times daily.
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., infantile hemangioma) have weight-based dosing.
Infant: Not established for routine use; specific indications (e.g., infantile hemangioma) have weight-based dosing (e.g., 0.6 mg/kg/day, increasing to 1.7 mg/kg/day).
Child: Hypertension: Initial 0.5 mg/kg/day in 2-4 divided doses, max 2 mg/kg/day. Migraine Prophylaxis: 1-2 mg/kg/day in 2-3 divided doses, max 4 mg/kg/day or 120 mg/day.
Adolescent: Similar to adult dosing, adjusted for weight and response.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for increased effects.
Severe: No specific adjustment needed, but monitor for increased effects; consider lower initial doses.
Dialysis: Not significantly removed by hemodialysis. No supplemental dose needed.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant dose reduction required (e.g., 50% reduction).
Severe: Contraindicated or very significant dose reduction required; use with extreme caution.

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, the mechanism is not fully understood but may involve blockade of beta-receptors in the cerebral vasculature or central nervous system effects. For tremor, it likely involves blockade of peripheral beta-2 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: 25-50% (highly variable due to extensive first-pass metabolism)
Tmax: 1-1.5 hours (immediate release); 6 hours (extended release)
FoodEffect: Food increases bioavailability and reduces peak plasma concentrations, but overall absorption is enhanced.

Distribution:

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

Elimination:

HalfLife: 3-6 hours (immediate release); 8-11 hours (extended release)
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes (oral)
PeakEffect: 1-1.5 hours (oral)
DurationOfAction: 6-12 hours (immediate release); 24 hours (extended release)

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 been observed 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 should be 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 pectoris should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent to discontinue propranolol therapy slowly even in patients treated only for hypertension.
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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 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ 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 heartbeat
Abnormal heartbeat
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Confusion
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or mood changes
Burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red)
Changes in 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, characterized by:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:

Dizziness
Drowsiness
Fatigue
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 (bradycardia)
  • Severe dizziness or fainting
  • Difficulty breathing, wheezing, or shortness of breath
  • Swelling in your ankles or feet, unusual weight gain (signs of worsening heart failure)
  • Chest pain or discomfort (especially if you stop the medication suddenly)
  • Unusual tiredness or weakness
  • Depression or mood changes
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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 heart conditions, such as:
+ 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, including:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

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 adjust the dosage 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
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.

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

Interactions with Other Substances
Discuss with your doctor before consuming alcohol. If you smoke, talk to your doctor about the potential risks. This medication may mask signs of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, particularly in individuals with diabetes, children, and those who are fasting or experiencing surgery, abnormal eating habits, or vomiting.

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 may lead to worsening chest pain or even a heart attack, especially if you have certain types of heart disease. To avoid side effects, your doctor will guide you on how to gradually stop taking this 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 signs of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult with your doctor.

Interactions with Over-the-Counter Products
If you have high blood pressure and are taking this medication, consult with your doctor before using over-the-counter 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 with your doctor the potential risks 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 epinephrine may be less effective while taking this medication.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss with your doctor the benefits and risks of taking this medication to 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
  • Hypoglycemia
  • Seizures
  • Coma

What to Do:

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

Drug Interactions

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Contraindicated Interactions

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

  • Other beta-blockers (additive effects)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal)
  • Digoxin (additive bradycardia)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • Sympathomimetics (e.g., epinephrine, norepinephrine, isoproterenol) (antagonism, risk of severe hypertension with alpha-agonists)
  • Fingolimod (risk of severe bradycardia)
  • Prazosin (risk of orthostatic hypotension)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Cimetidine, fluoxetine, paroxetine, quinidine (CYP2D6 inhibitors, may increase propranolol levels)
  • Phenobarbital, rifampin, phenytoin (CYP inducers, may decrease propranolol levels)
  • Alcohol (may increase propranolol levels)
  • Lidocaine (increased lidocaine levels)
  • Theophylline (mutual antagonism)
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Minor Interactions

  • Antacids (may decrease propranolol absorption)
  • Cholestyramine, colestipol (may decrease propranolol absorption)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension or other conditions where BP control is relevant.

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) that may contraindicate use.

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

Renal Function (BUN, Creatinine)

Rationale: Although primarily metabolized by liver, renal excretion of metabolites occurs; important for overall patient assessment.

Timing: Prior to initiation.

Hepatic Function (ALT, AST, Bilirubin)

Rationale: Propranolol is extensively metabolized by the liver; hepatic impairment requires dose adjustment.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly initially, then monthly or quarterly)

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

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

Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or quarterly)

Target: Typically >50-60 bpm at rest (unless target is lower for specific arrhythmias)

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

Symptoms of Bronchospasm

Frequency: Ongoing

Target: Not applicable

Action Threshold: New or worsening shortness of breath, wheezing, especially in patients with asthma/COPD.

Blood Glucose (in diabetics)

Frequency: Regularly (as per diabetes management plan)

Target: Individualized

Action Threshold: Frequent or severe hypoglycemia, or masked symptoms of hypoglycemia.

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, lethargy
  • Cold extremities
  • Bronchospasm (shortness of breath, wheezing, cough)
  • Worsening heart failure (edema, dyspnea, weight gain)
  • Depression, sleep disturbances
  • Masked symptoms of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Propranolol is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It has been associated with fetal growth restriction, bradycardia, and hypoglycemia in neonates.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed.
Second Trimester: Potential for fetal growth restriction and bradycardia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression, especially if used close to delivery. Withdrawal symptoms in neonates have been reported.
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Lactation

Propranolol is excreted into breast milk. While generally considered compatible with breastfeeding, monitor the infant for signs of beta-blockade (e.g., bradycardia, hypotension, lethargy, hypoglycemia). Use the lowest effective dose.

Infant Risk: Low to moderate risk. Potential for bradycardia, hypotension, and hypoglycemia in the infant, especially in preterm or sick infants, or with high maternal doses. Monitor infant closely.
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Pediatric Use

Dosing is weight-based and varies by indication. Close monitoring for adverse effects (especially bradycardia, hypotension, hypoglycemia) is crucial. Specific formulations (e.g., Hemangeol for infantile hemangioma) are available for pediatric use.

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Geriatric Use

Elderly patients may be more sensitive to the effects of propranolol, particularly bradycardia and hypotension. Start with lower doses and titrate slowly. Monitor renal and hepatic function, as these may be impaired in the elderly.

Clinical Information

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Clinical Pearls

  • Propranolol is a non-selective beta-blocker, meaning it affects both beta-1 (heart) and beta-2 (lungs, blood vessels) receptors. This makes it effective for a wide range of conditions but also increases the risk of bronchospasm in patients with asthma or COPD.
  • Always emphasize the importance of gradual withdrawal to patients to prevent rebound phenomena, especially in those with underlying ischemic heart disease.
  • It's highly lipophilic, which contributes to its CNS effects (e.g., fatigue, depression, sleep disturbances) but also makes it effective for conditions like migraine prophylaxis and essential tremor.
  • Food significantly increases its bioavailability, so consistent administration with respect to meals is important for stable drug levels.
  • Be mindful of drug interactions, particularly with other agents that slow heart rate or affect blood pressure, and with CYP450 inhibitors/inducers.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol)
  • Calcium channel blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • ARBs (e.g., losartan, valsartan)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • For migraine prophylaxis: Topiramate, Valproic acid, CGRP inhibitors
  • For essential tremor: Primidone
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (40mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.