Propranolol 60mg 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
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Pharmacologic Class
Non-selective beta-adrenergic blocker
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Pregnancy Category
C
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FDA Approved
Jan 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a medication that works by blocking certain natural chemicals in your body, like adrenaline, that affect the heart and blood vessels. This helps to slow down your heart rate, relax blood vessels, and reduce the strain on your heart. It's used to treat high blood pressure, chest pain (angina), irregular heartbeats, and to prevent migraine headaches.
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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.

It's crucial to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.

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 excessive heat, cold, and light. Keep the container tightly closed to prevent moisture and other environmental factors from affecting the medication.

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 medication exactly as prescribed, at the same time each day.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid alcohol, as it can increase the levels of propranolol in your body.
  • Be cautious when standing up quickly, as you may feel dizzy.
  • If you have diabetes, monitor your blood sugar closely, as propranolol can mask symptoms of low blood sugar.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage varies widely by indication. For hypertension: 40 mg twice daily initially, may increase to 120-240 mg/day. For angina pectoris: 80-320 mg/day in 2-4 divided doses. For migraine prophylaxis: 80 mg/day initially, usually 160-240 mg/day in divided doses.
Dose Range: 20 - 640 mg

Condition-Specific Dosing:

hypertension: 40 mg twice daily initially, maintenance 120-240 mg/day
anginaPectoris: 80-320 mg/day in 2-4 divided doses
migraineProphylaxis: 80 mg/day initially, maintenance 160-240 mg/day in divided doses
arrhythmias: 10-30 mg 3-4 times daily
essentialTremor: 40 mg twice daily initially, maintenance 120-320 mg/day
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, often off-label for specific conditions like infantile hemangioma)
Infant: Not established (use with extreme caution, often off-label for specific conditions like infantile hemangioma)
Child: Hypertension: 0.5-1 mg/kg/day in 2-4 divided doses, max 2 mg/kg/day or 60 mg/day. Arrhythmias: 0.5-1 mg/kg/day in 3-4 divided doses, max 2 mg/kg/day or 60 mg/day.
Adolescent: Similar to adult dosing, starting at lower end of range 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: No specific adjustment needed, but monitor for exaggerated response due to accumulation of active metabolites. Use with caution.
Dialysis: Not significantly removed by hemodialysis. No supplemental dose needed after dialysis. Monitor for exaggerated response.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant dose reduction required (e.g., 50% or more). 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 blocks beta-1 (myocardial) and beta-2 (bronchial and vascular smooth muscle) adrenergic receptors. This leads to decreased heart rate, myocardial contractility, and cardiac output, reducing blood pressure. It also inhibits renin release from the kidneys. In migraine, its mechanism is not fully understood but may involve modulation of cerebral blood flow and neurotransmitter release.
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Pharmacokinetics

Absorption:

Bioavailability: 10-60% (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, extending Tmax.

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, <1% as unchanged drug)
Unchanged: <1%
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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 propranolol in patients with ischemic heart disease may exacerbate angina, precipitate myocardial infarction, or ventricular arrhythmias. 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 markedly 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. Because coronary artery disease is common and may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease.
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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 immediately or seek emergency medical attention:

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 a rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ A 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 sensations, such as burning, numbness, or tingling
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
Difficulty getting or maintaining an erection
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 if they bother you or do not go away:

Dizziness, drowsiness, tiredness, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Difficulty sleeping
Strange or unusual dreams

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (less than 50 beats per minute)
  • Shortness of breath, wheezing, or difficulty breathing
  • Swelling of ankles or feet
  • Unusual weight gain
  • Persistent fatigue or weakness
  • Coldness, numbness, or pain in hands or feet
  • Symptoms of depression (mood changes, loss of interest)
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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 like heart block or sick-sinus syndrome
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor 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 medications (prescription, over-the-counter, natural products, and vitamins) and health concerns with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and other drugs. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 be cautious 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 with your doctor before consuming alcohol. 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 stop taking this medication abruptly, as this may lead to worsened 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 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 if you have any concerns.

Interactions with Other Medications
If you have high blood pressure, consult with 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 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 this medication may affect the efficacy 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. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve IV fluids, atropine for bradycardia, glucagon, 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)
  • Antiarrhythmics (e.g., amiodarone, disopyramide, quinidine - increased risk of bradycardia, AV block)
  • Digitalis glycosides (increased risk of bradycardia, AV block)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not withdrawn first)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • Sympathomimetics (e.g., epinephrine, norepinephrine - attenuated pressor response, risk of severe hypertension with alpha-agonists)
  • Ergot alkaloids (increased peripheral vasoconstriction)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine - increased propranolol levels)
  • CYP1A2 inhibitors (e.g., fluvoxamine - increased propranolol levels)
  • CYP2C19 inhibitors (e.g., omeprazole - increased propranolol levels)
  • Phenytoin, phenobarbital, rifampin (CYP inducers - decreased propranolol levels)
  • Alcohol (increased propranolol levels)
  • Cimetidine (increased propranolol levels)
  • Lidocaine (increased lidocaine levels)
  • Theophylline (reduced clearance of theophylline)
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Minor Interactions

  • Antacids (may decrease absorption of propranolol)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide 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 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 kidney health, though dose adjustment is rarely needed, it's important for overall patient assessment.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess hepatic 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., weekly during titration, then monthly/quarterly)

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

Action Threshold: Hypotension (e.g., SBP <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/quarterly)

Target: Typically >50-60 bpm (unless specific therapeutic bradycardia is desired)

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

Symptoms of Adverse Effects

Frequency: At each visit and patient education for self-monitoring

Target: Absence of symptoms

Action Threshold: Development of new or worsening symptoms (e.g., dizziness, fatigue, shortness of breath, cold extremities)

Blood Glucose (in diabetics)

Frequency: Regularly, as per diabetes management guidelines

Target: Individualized

Action Threshold: Hypoglycemia (propranolol can mask symptoms)

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, lethargy
  • Cold hands and feet (peripheral vasoconstriction)
  • Shortness of breath, wheezing (bronchospasm, especially in asthmatics)
  • Insomnia, nightmares
  • Depression
  • Nausea, vomiting, diarrhea, constipation
  • Masked symptoms of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Propranolol is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to beta-blockers in utero may be at risk for bradycardia, hypoglycemia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided if possible due to potential for fetal growth restriction and other adverse effects seen with beta-blockers.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia. Close monitoring of fetal growth and heart rate is recommended.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Discontinuation several days before delivery is often considered if clinically feasible.
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Lactation

Propranolol is excreted into breast milk. The American Academy of Pediatrics considers it 'compatible with breastfeeding'. However, monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy, hypoglycemia). Use with caution, especially in premature or unstable infants.

Infant Risk: L3 (Moderately safe). Low risk of adverse effects in healthy, full-term infants, but potential for bradycardia, hypotension, and hypoglycemia, especially in neonates or infants with underlying conditions.
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Pediatric Use

Dosing must be carefully individualized based on weight, age, and indication. Neonates and infants are particularly sensitive to the effects of beta-blockade. Close monitoring for bradycardia, hypotension, and hypoglycemia is essential. Specific formulations (e.g., oral solution for infantile hemangioma) are available.

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Geriatric Use

Elderly patients may be more sensitive to the effects of propranolol, particularly bradycardia and hypotension. Lower initial doses and slower titration are recommended. Renal and hepatic function should be assessed, as age-related decline in these functions can affect drug clearance.

Clinical Information

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Clinical Pearls

  • Always warn patients about the risk of abrupt discontinuation, especially if they have underlying ischemic heart disease.
  • Propranolol is highly lipophilic, leading to significant CNS penetration, which can cause side effects like nightmares, insomnia, and depression.
  • It is a non-selective beta-blocker, so it should be used with extreme caution or avoided in patients with asthma, COPD, or other bronchospastic diseases due to the risk of bronchospasm.
  • Can mask symptoms of hypoglycemia in diabetic patients, except for sweating.
  • Food significantly increases the bioavailability of propranolol; advise consistent administration with respect to meals (e.g., always with food or always on an empty stomach).
  • Extended-release formulations (Inderal LA) allow for once-daily dosing, improving adherence.
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Alternative Therapies

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

Average Cost: Varies widely, typically $10-$50 per 30 tablets (60mg)
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 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.