Propranolol ER 80mg Capsules

Propranolol is a non-selective beta-adrenergic receptor blocker that competitively antagonizes both beta-1 and beta-2 adrenergic receptors. This results in decreased heart rate, myocardial contractility, and cardiac output (beta-1 blockade), as well as bronchoconstriction and peripheral vasoconstriction (beta-2 blockade). It also inhibits renin release from the kidneys and has a central nervous system effect, contributing to its use in migraine prophylaxis and essential tremor.

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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar: dizziness, headache, feeling sleepy, weak, shaking, rapid heartbeat, confusion, hunger, or sweating
Signs of lupus: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs
Severe dizziness or fainting
New or worsening chest pain
Slow heartbeat or irregular heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or 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) on hands, feet, or other areas
Changes in vision
Unexplained bruising or bleeding
Fever, chills, or sore throat
Erectile dysfunction
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions, characterized by 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

Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, drowsiness, fatigue, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Difficulty sleeping
* Vivid or unusual dreams

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.

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 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.

To ensure your safety, 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

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.

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
Until you know how this medication affects you, avoid driving and other tasks 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. Additionally, this medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, particularly in individuals with diabetes, children, and those who are fasting or undergoing 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 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 instruct 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 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 anaphylaxis. 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, consult with your doctor to discuss the benefits and risks of this medication to you and your baby.

• 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 hypertensive crisis)

• Other antiarrhythmics (e.g., amiodarone, flecainide, quinidine, disopyramide) - increased risk of bradycardia, heart block, myocardial depression
• Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered first)
• Digoxin (increased risk of bradycardia)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
• Sympathomimetics (e.g., epinephrine, norepinephrine, pseudoephedrine) - unopposed alpha-adrenergic stimulation leading to hypertension and bradycardia
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased peripheral vasoconstriction

• NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect of propranolol
• Cimetidine, fluoxetine, paroxetine, quinidine (CYP2D6 inhibitors) - increased propranolol levels
• Rifampin, phenobarbital, phenytoin (CYP inducers) - decreased propranolol levels
• Alpha-1 blockers (e.g., prazosin, doxazosin) - increased risk of first-dose hypotension
• General anesthetics (e.g., halothane, isoflurane) - increased risk of myocardial depression and hypotension
• Alcohol (increased propranolol levels and enhanced hypotensive effect)

• Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - may decrease propranolol absorption
• Cholestyramine, colestipol (may decrease propranolol absorption)

• Dizziness or lightheadedness (hypotension)
• Fatigue or lethargy
• Shortness of breath or wheezing (bronchospasm, especially in asthmatics)
• Cold hands and feet (peripheral vasoconstriction)
• Depression or mood changes
• Sleep disturbances or nightmares
• Signs of worsening heart failure (e.g., swelling, weight gain, increased dyspnea)
• Symptoms of hypoglycemia (e.g., sweating, tremor, palpitations - note: propranolol can mask these)

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

Propranolol is excreted into breast milk. The American Academy of Pediatrics considers it 'compatible with breastfeeding' but advises monitoring the infant for signs of beta-blockade.

Propranolol ER is generally not recommended for pediatric use due to lack of established safety and efficacy data. Immediate-release formulations are used for specific pediatric indications (e.g., infantile hemangioma, certain arrhythmias) with careful dose titration.

Elderly patients may be more sensitive to the effects of beta-blockers, particularly regarding bradycardia and hypotension. Lower initial doses and careful titration are recommended. Renal and hepatic function should be monitored.

• Always taper propranolol dose gradually over 1-2 weeks to avoid rebound angina, myocardial infarction, or arrhythmias, especially in patients with coronary artery disease.
• Propranolol is non-selective, meaning it blocks both beta-1 and beta-2 receptors. This can lead to bronchospasm in patients with asthma or COPD and can mask symptoms of hypoglycemia in diabetics.
• Take propranolol ER consistently with or without food, but preferably with food to enhance absorption and reduce variability. If taken with food, always take it with food.
• Monitor heart rate and blood pressure closely, especially during initiation and dose titration.
• Patients should be advised to report any signs of heart failure (e.g., shortness of breath, swelling, weight gain) immediately.
• Due to its lipophilicity, propranolol has good CNS penetration, which contributes to its efficacy in migraine prophylaxis and essential tremor, but also to CNS side effects like fatigue, depression, and sleep disturbances.

• 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-blockers (e.g., prazosin, doxazosin)
• Other migraine prophylactic agents (e.g., topiramate, amitriptyline, CGRP inhibitors)
• Other essential tremor treatments (e.g., primidone)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.