Propranolol ER 60mg Capsules

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks both beta-1 (β1) and beta-2 (β2) adrenergic receptors. Beta-1 blockade in the heart leads to decreased heart rate, myocardial contractility, and cardiac output, thus lowering blood pressure and reducing myocardial oxygen demand. Beta-2 blockade in the bronchi and peripheral vasculature can lead to bronchoconstriction and increased peripheral vascular resistance. It also has membrane-stabilizing activity (quinidine-like effect) at high doses and lacks intrinsic sympathomimetic activity (ISA). Its antihypertensive effect is thought to be due to decreased cardiac output, inhibition of renin release by the kidneys, and central nervous system 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
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, 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. 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 list is not exhaustive, and you may experience other side effects not mentioned here. 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-related 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 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 safe treatment, 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

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in combination with this medication.

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 engaging in activities 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, 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 interfere with certain lab 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, particularly in individuals with diabetes, children, and those who are fasting or experiencing vomiting.

Special Considerations
If you have diabetes, closely monitor your blood sugar levels. 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 adverse effects, your doctor will guide you on how to gradually discontinue the medication. Seek immediate medical attention if you experience new or worsening chest pain or other heart problems.

Thyroid and Blood Pressure Considerations
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as rapid heartbeat. If you have hyperthyroidism and suddenly stop taking this medication, your condition may worsen and become life-threatening. Consult your doctor before using over-the-counter products that may increase blood pressure, such as cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Allergic Reactions and Epinephrine
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, consult your doctor to discuss the benefits and risks of this medication to you and your baby.

• MAO inhibitors (risk of severe hypertension)
• Thioridazine (increased thioridazine levels, risk of QT prolongation and arrhythmias)
• Cimetidine (significant increase in propranolol levels)

• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem - risk of severe bradycardia, AV block, heart failure)
• Other beta-blockers (additive effects)
• Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered first)
• Digoxin (additive bradycardia)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
• Fingolimod (risk of severe bradycardia)
• Alpha-1 blockers (e.g., prazosin - risk of first-dose hypotension)
• Antiarrhythmics (e.g., amiodarone, flecainide, propafenone - additive cardiac depression)

• 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)
• Rifampin (decreased propranolol levels)
• Phenytoin, phenobarbital (decreased propranolol levels)
• Lidocaine (increased lidocaine levels)
• Warfarin (potential for altered INR, monitor closely)
• Epinephrine (paradoxical hypertension and bradycardia)

• Alcohol (may increase propranolol levels)
• Tobacco smoking (may decrease propranolol levels)

• Dizziness
• Lightheadedness
• Fatigue
• Bradycardia (slow pulse)
• Shortness of breath
• Wheezing
• Cold hands/feet
• Sleep disturbances (insomnia, nightmares)
• Depression
• Nausea
• Diarrhea/Constipation
• Signs of hypoglycemia (sweating, tremor, confusion - note: these may be masked)

Propranolol crosses the placenta. Use during pregnancy should only be considered 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.

Propranolol is excreted into breast milk. While the amount is generally low, monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding, hypoglycemia). Use with caution, especially in premature or unstable infants.

Safety and effectiveness of Propranolol ER in pediatric patients have not been established. Immediate-release propranolol is used off-label for various pediatric conditions (e.g., infantile hemangioma, hypertension, migraine prophylaxis), with dosing based on weight and indication. ER formulation is generally not recommended for initial pediatric use due to lack of specific studies and difficulty in dose titration.

Elderly patients may be more sensitive to the effects of beta-blockers, particularly bradycardia and hypotension. Start with lower doses and titrate slowly with careful monitoring. Renal and hepatic function should be assessed, as these may be impaired in the elderly.

• Propranolol ER is designed for once-daily dosing, providing smoother blood pressure control and better adherence compared to immediate-release formulations.
• Always taper propranolol slowly over 1-2 weeks when discontinuing, especially in patients with coronary artery disease, to avoid rebound angina, MI, or arrhythmias.
• Non-selective beta-blockade means it can cause bronchoconstriction; use with extreme caution or avoid in patients with asthma, COPD, or other reactive airway diseases.
• Can mask symptoms of hypoglycemia (e.g., tremor, palpitations) in diabetic patients, making it harder to recognize low blood sugar. Patients should be educated on other signs like sweating and confusion.
• May exacerbate peripheral vascular disease symptoms due to beta-2 blockade leading to vasoconstriction.
• Consider the impact on lipid profiles (may increase triglycerides and decrease HDL cholesterol, though clinical significance is debated).

• Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol)
• 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)
• For migraine prophylaxis: Topiramate, Valproic acid, CGRP inhibitors, Amitriptyline
• For essential tremor: Primidone

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 information about the medication taken, the amount, and the time it happened.