Propranolol ER 160mg Capsules

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks beta-1 (cardiac) and beta-2 (bronchial and vascular) adrenergic receptors. This leads to decreased heart rate, myocardial contractility, and cardiac output, resulting in reduced blood pressure. It also inhibits renin release from the kidneys. For migraine, its mechanism is not fully understood but may involve modulation of cerebral blood flow and neurotransmitter release. For tremor, it may act on peripheral beta-2 receptors.

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. Many people experience no side effects or only mild ones. However, if you notice 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, 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.

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 symptoms you experienced as a result of the allergy.
Certain heart-related conditions, including:
+ Abnormal heart rhythms, such as heart block or sick-sinus syndrome
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to your 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 health problems and medications with your doctor. 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 dosage of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.

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 know how this medication affects you, avoid driving and other 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 and Lab Tests
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Be aware that this medication may affect certain lab test results, 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 some symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar, especially in people with diabetes, children, and those who are fasting or have undergone surgery.

Managing Diabetes
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 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, seek medical attention 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, inform 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, discuss with 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, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for 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 severe hypertension)

• Other antihypertensives (additive hypotensive effects)
• Antiarrhythmics (e.g., amiodarone, digoxin - risk of bradycardia, AV block)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
• Clonidine (rebound hypertension upon clonidine withdrawal if propranolol is not tapered first)
• NSAIDs (may reduce antihypertensive effect of propranolol)
• Adrenergic-stimulating drugs (e.g., epinephrine, norepinephrine - unopposed alpha-adrenergic stimulation leading to severe hypertension and bradycardia)
• Phenytoin, phenobarbital, rifampin (inducers of propranolol metabolism, decreasing levels)
• Cimetidine, fluoxetine, paroxetine, quinidine (inhibitors of propranolol metabolism, increasing levels)

• Alcohol (may increase propranolol levels)
• Theophylline (propranolol may inhibit clearance of theophylline)
• Lidocaine (propranolol may reduce lidocaine clearance)
• Ergot alkaloids (increased peripheral vasoconstriction)

• Antacids (may reduce absorption of propranolol if taken concurrently)

• Dizziness or lightheadedness (hypotension)
• Fatigue or lethargy
• Bradycardia (slow heart rate)
• Shortness of breath or wheezing (bronchospasm, especially in asthmatics)
• Cold hands and feet (peripheral vasoconstriction)
• Depression or mood changes
• Sleep disturbances (insomnia, nightmares)
• Signs of worsening heart failure (e.g., swelling, weight gain, increased dyspnea)

Propranolol is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers can cause bradycardia, hypoglycemia, and respiratory depression in the neonate.

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

Safety and efficacy of propranolol ER in pediatric patients have not been fully established. While immediate-release propranolol is used off-label for certain pediatric conditions (e.g., hypertension, migraine prophylaxis, infantile hemangiomas), ER formulations require careful consideration due to different pharmacokinetics and lack of specific pediatric dosing guidelines for all indications. Dosing is typically weight-based and requires careful titration.

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, affecting drug clearance.

• Propranolol ER is taken once daily, usually at bedtime for Innopran XL, or consistently with or without food for Inderal LA. Adherence to the specific brand's instructions is important.
• It is a non-selective beta-blocker, meaning it blocks both beta-1 and beta-2 receptors. This makes it effective for conditions like migraine and tremor, but also increases the risk of bronchospasm in patients with asthma or COPD.
• The black box warning regarding abrupt discontinuation is critical. Patients should be educated on the importance of gradual tapering.
• Propranolol can mask symptoms of hypoglycemia in diabetic patients and hyperthyroidism (e.g., tachycardia).
• It is highly lipophilic, leading to good CNS penetration, which may contribute to its efficacy in migraine and tremor, but also to CNS side effects like fatigue, depression, and sleep disturbances.

• 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, diltiazem, verapamil)
• Diuretics (e.g., hydrochlorothiazide, furosemide)
• For migraine prophylaxis: Topiramate, valproic acid, CGRP inhibitors, amitriptyline.
• For essential tremor: 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.