Propranolol 20mg Tablets

Manufacturer AMICI PHARMACEUTICALS 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, Anti-tremor
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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 type of medicine called a beta-blocker. It works by blocking certain natural chemicals in your body, like adrenaline, from affecting your heart and blood vessels. This helps to slow down your heart rate, relax your blood vessels, and lower your blood pressure. It can also help with conditions like chest pain (angina), irregular heartbeats, migraines, and tremors.
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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 should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance.
Continue taking your medication as prescribed 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, avoiding freezing temperatures.
Protect the medication from heat, cold, and light sources.
Keep the container lid tightly closed at all times.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

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 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.
  • Take your pulse and blood pressure regularly as advised by your doctor.
  • Avoid activities that require alertness until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • Avoid alcohol, as it can increase the effects of propranolol.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • If you have diabetes, be aware that propranolol can mask the signs of low blood sugar (hypoglycemia), such as a fast heartbeat.

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage is highly individualized based on indication and patient response. For hypertension, initial 40 mg twice daily. For angina, initial 80 mg/day in 2-4 divided doses. For migraine prophylaxis, initial 80 mg/day in divided doses.
Dose Range: 10 - 640 mg

Condition-Specific Dosing:

Hypertension: Initial 40 mg twice daily; usual maintenance 120-240 mg/day in 2-3 divided doses.
Angina Pectoris: 80-320 mg/day in 2-4 divided doses.
Migraine Prophylaxis: Initial 80 mg/day in divided doses; usual maintenance 160-240 mg/day.
Essential Tremor: Initial 40 mg twice daily; usual maintenance 120-320 mg/day.
Arrhythmias: 10-30 mg three or four times daily, before meals and at bedtime.
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., infantile hemangioma) have specialized dosing.
Infant: Not established for routine use; specific indications (e.g., infantile hemangioma) have specialized dosing.
Child: Dosing is highly individualized based on indication (e.g., hypertension, arrhythmias, migraine prophylaxis) and weight. Typically 0.5-1 mg/kg/day in 2-4 divided doses, titrating up to a maximum of 2-4 mg/kg/day or adult maximum dose.
Adolescent: Similar to adult dosing, starting with lower doses and titrating based on response and tolerability.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for exaggerated response.
Severe: Use with caution; monitor for exaggerated response. Accumulation of active metabolites may occur.
Dialysis: Propranolol is not significantly removed by hemodialysis. No supplemental dose needed post-dialysis, but monitor for effects.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant dose reduction required due to extensive hepatic metabolism. Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution and significant dose reduction. Monitor closely for adverse effects and accumulation.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively antagonizes beta-1 and beta-2 adrenergic receptors. This leads to decreased heart rate, myocardial contractility, cardiac output, and blood pressure. It also inhibits renin release from the kidneys. Its effects on beta-2 receptors can cause bronchoconstriction and peripheral vasoconstriction. It also has membrane-stabilizing activity (quinidine-like effect) at high doses.
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Pharmacokinetics

Absorption:

Bioavailability: 10-60% (highly variable due to extensive first-pass metabolism)
Tmax: 1-1.5 hours (immediate release)
FoodEffect: Food increases bioavailability and reduces variability.

Distribution:

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

Elimination:

HalfLife: 3-6 hours
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30 minutes (oral)
PeakEffect: 1-1.5 hours
DurationOfAction: 6-12 hours

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABRUPT CESSATION OF THERAPY. Do not discontinue Propranolol Tablets therapy abruptly, especially in patients with ischemic heart disease. Severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias have been reported following abrupt discontinuation of beta-blocker therapy. When discontinuing chronically administered Propranolol Tablets, 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 markedly worsens or acute coronary insufficiency develops, Propranolol Tablets administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Propranolol Tablets therapy abruptly 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 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
+ 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
Unusual 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, 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
Fatigue
Weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Sleep disturbances
* Vivid or unusual dreams

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 fainting
  • Very slow heartbeat (less than 50 beats per minute)
  • Shortness of breath or difficulty breathing, especially if new or worsening
  • Swelling in your ankles or feet
  • Unusual weight gain
  • Chest pain (especially if you stop the medication suddenly)
  • Coldness, numbness, or pain in your hands or feet
  • Depression or unusual 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain heart-related conditions, including:
+ Abnormal heart rhythms, such as heart block or sick-sinus syndrome
+ Heart failure (a weak heart)
+ Low blood pressure
+ Poor blood circulation to your arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory conditions, 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.

To ensure your safety, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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. This will help ensure your safety and prevent any potential interactions with other treatments.

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Monitoring Your Condition

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

Managing Blood Sugar

If you have diabetes, closely monitor your blood sugar levels. If you have any questions or concerns, consult your doctor.

Stopping the Medication

Do not stop taking this medication abruptly, as this can 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 instruct 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 symptoms 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 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 your condition with your doctor. You may be at risk of a 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 affect the efficacy of epinephrine.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

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 conduction abnormalities (risk of severe bradycardia, heart block, asystole)
  • MAO inhibitors (risk of hypertensive crisis)
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Major Interactions

  • Other beta-blockers (additive effects)
  • Antiarrhythmics (e.g., amiodarone, digoxin - increased risk of bradycardia, AV block)
  • Clonidine (risk of rebound hypertension if clonidine is abruptly withdrawn while on propranolol)
  • Insulin and oral hypoglycemics (may mask symptoms of hypoglycemia, prolong hypoglycemic response)
  • NSAIDs (may reduce antihypertensive effect of propranolol)
  • Alpha-1 blockers (e.g., prazosin - increased risk of orthostatic hypotension)
  • Cimetidine (increases propranolol plasma levels)
  • Rifampin (decreases propranolol plasma levels)
  • Phenytoin, Phenobarbital (may decrease propranolol levels)
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Moderate Interactions

  • Alcohol (may increase propranolol levels)
  • Fluoxetine, Paroxetine (may increase propranolol levels due to CYP2D6 inhibition)
  • Thioridazine (increased risk of QT prolongation and arrhythmias)
  • Lidocaine (propranolol may reduce lidocaine clearance, increasing toxicity risk)
  • Theophylline (propranolol may inhibit theophylline clearance)
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Minor Interactions

  • Antacids (may decrease propranolol absorption if taken concurrently)
  • Smoking (may decrease propranolol levels)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide dose titration for antihypertensive effect.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and conduction, especially in patients with pre-existing cardiac conditions.

Timing: Prior to initiation (if clinically indicated)

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, as metabolites are renally excreted.

Timing: Prior to initiation

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Blood Glucose

Rationale: For diabetic patients, to assess baseline and monitor for masking of hypoglycemia.

Timing: Prior to initiation

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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 to quarterly)

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

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

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly to quarterly)

Target: Typically >50-60 bpm (unless target bradycardia for specific conditions)

Action Threshold: Bradycardia (<50 bpm or symptomatic), or inadequate control

Symptoms of Heart Failure

Frequency: At each visit

Target: Absence of new or worsening symptoms (e.g., dyspnea, edema, weight gain)

Action Threshold: Development or worsening of heart failure symptoms

Respiratory Status (e.g., wheezing, dyspnea)

Frequency: At each visit, especially in patients with history of asthma/COPD

Target: Normal breathing

Action Threshold: Development of bronchospasm or increased respiratory distress

Blood Glucose (for diabetics)

Frequency: Regularly, as per diabetes management guidelines

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Wheezing
  • Cold hands/feet
  • Depression
  • Sleep disturbances
  • Unusual weight gain
  • Swelling in ankles/feet
  • Chest pain (especially if abruptly discontinued)

Special Patient Groups

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Pregnancy

Propranolol is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers have been associated with fetal growth restriction, bradycardia, and hypoglycemia. Neonates exposed to beta-blockers in utero may be at risk for hypoglycemia, bradycardia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations. Use only if clearly needed.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia. Monitor fetal growth and heart rate.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonate closely for 24-48 hours after birth.
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Lactation

Propranolol is excreted into breast milk. The American Academy of Pediatrics considers propranolol to be compatible with breastfeeding. However, monitor the infant for signs of beta-blockade (e.g., bradycardia, lethargy, hypoglycemia), especially in neonates or premature infants.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and hypoglycemia. Generally considered compatible with breastfeeding with careful monitoring.
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Pediatric Use

Use with caution and individualized dosing. Pediatric patients may be more sensitive to the effects of beta-blockade. Monitor closely for bradycardia, hypotension, and hypoglycemia. Specific indications like infantile hemangioma have specialized dosing protocols.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to beta-blockers and potential for decreased renal/hepatic function. Elderly patients may be at increased risk for adverse effects such as bradycardia, hypotension, and central nervous system effects (e.g., confusion, depression).

Clinical Information

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Clinical Pearls

  • Propranolol is a highly lipophilic beta-blocker, which allows it to readily cross the blood-brain barrier, contributing to its efficacy in conditions like migraine prophylaxis, essential tremor, and anxiety.
  • Due to its non-selective nature, it is generally contraindicated or used with extreme caution in patients with asthma, severe COPD, or other bronchospastic diseases.
  • It can mask the signs of hypoglycemia in diabetic patients, particularly tachycardia, making it harder for patients to recognize low blood sugar.
  • Abrupt discontinuation can lead to rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with underlying ischemic heart disease. Tapering is crucial.
  • Food increases the bioavailability of propranolol, so consistent administration with food is recommended to maintain stable drug levels.
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Alternative Therapies

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

Average Cost: $10 - $30 per 30 tablets (20mg generic)
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 medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.