Propranolol ER 120mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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 must be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
When taking this medication in capsule form, swallow the capsule whole. Do not chew, break, or crush it, as this can affect the way the medication works.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. Stopping your medication without consulting your doctor can affect its effectiveness.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store your medication at room temperature, away from extreme heat, cold, and light.
Keep the container tightly closed to prevent moisture and other environmental factors from affecting the medication.
Do not freeze your medication, as this can alter its composition and effectiveness.
What to Do If You Miss a Dose
If you miss a dose of your medication:
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 a missed dose, as this can increase the risk of side effects.
Lifestyle & Tips
- Continue to follow a heart-healthy diet (low in salt, saturated fat, cholesterol).
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Avoid smoking.
- Manage stress effectively.
- Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
Available Forms & Alternatives
Available Strengths:
- Propranolol 20mg/5ml Solution
- Propranolol 40mg/5ml Solution
- Propranolol 40mg Tablets
- Propranolol ER 60mg Capsules
- Propranolol ER 160mg Capsules
- Propranolol ER 80mg Capsules
- Propranolol ER 120mg Capsules
- Propranolol 1mg/ml Inj, 1ml
- Propranolol 20mg Tablets
- Propranolol 60mg Tablets
- Propranolol 80mg Tablets
- Propranolol 10mg Tablets
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 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 rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ 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 burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red) or 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, tiredness, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Sleep disturbances
* Vivid or unusual dreams
Reporting 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.
Seek Immediate Medical Attention If You Experience:
- Very slow heart rate (less than 50 beats per minute)
- Dizziness or lightheadedness, especially when standing up
- Shortness of breath, wheezing, or difficulty breathing (especially if you have asthma or COPD)
- Swelling in your ankles or feet, unusual weight gain (signs of heart failure)
- New or worsening chest pain (if you stop the medication suddenly)
- Coldness, numbness, or tingling in your fingers or toes
Before Using This Medicine
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 blood 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. 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
To ensure your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & 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 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 affect certain laboratory 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, 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 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 side effects, your doctor will guide 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 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 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, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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 or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include atropine for bradycardia, glucagon, vasopressors, and intravenous fluids.
Drug Interactions
Contraindicated Interactions
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) in patients with severe left ventricular dysfunction or AV conduction abnormalities (risk of severe bradycardia, heart block, heart failure).
Major Interactions
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May significantly increase propranolol plasma concentrations, leading to increased beta-blockade and adverse effects.
- Other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics): Additive hypotensive effects.
- Clonidine: Abrupt withdrawal of clonidine while on propranolol can lead to severe rebound hypertension. Propranolol should be discontinued several days before gradual withdrawal of clonidine.
- Insulin and oral hypoglycemics: Beta-blockers can mask symptoms of hypoglycemia (e.g., tremor, tachycardia) and prolong hypoglycemic episodes.
Moderate Interactions
- NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of propranolol.
- Alpha-1 adrenergic blockers (e.g., prazosin, doxazosin): May cause additive hypotensive effects, especially orthostatic hypotension.
- Digoxin: May cause additive bradycardia.
- Sympathomimetics (e.g., epinephrine, norepinephrine): May cause unopposed alpha-adrenergic stimulation, leading to severe hypertension and bradycardia.
- Cimetidine, Hydralazine: May increase propranolol levels.
Minor Interactions
- Aluminum hydroxide gel: May decrease propranolol absorption.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide initial dosing for hypertension.
Timing: Prior to initiation.
Rationale: To establish baseline and assess for bradycardia, a common side effect.
Timing: Prior to initiation.
Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block).
Timing: Prior to initiation, especially in patients with cardiac history.
Rationale: To assess baseline kidney function, though renal adjustment is usually not needed, severe impairment warrants caution.
Timing: Prior to initiation.
Rationale: To assess baseline liver function, as propranolol is extensively metabolized by the liver.
Timing: Prior to initiation.
Routine Monitoring
Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly, then every 3-6 months).
Target: Individualized, typically <130/80 mmHg for hypertension.
Action Threshold: If persistently high, consider dose adjustment; if too low (e.g., symptomatic hypotension), consider dose reduction.
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: Typically >50-60 bpm (unless specific therapeutic goal for lower HR).
Action Threshold: If <50 bpm or symptomatic bradycardia, consider dose reduction or discontinuation.
Frequency: Periodically, especially in patients with underlying cardiac disease.
Target: Absence of new or worsening symptoms.
Action Threshold: If new or worsening dyspnea, edema, or fatigue, evaluate for heart failure exacerbation.
Frequency: More frequent monitoring, especially during initiation or dose changes.
Target: Individualized.
Action Threshold: If unexplained hypoglycemia or difficulty recognizing symptoms, adjust diabetes regimen or consider alternative antihypertensive.
Symptom Monitoring
- Bradycardia (slow heart rate)
- Hypotension (dizziness, lightheadedness, fainting)
- Fatigue, weakness
- Shortness of breath, wheezing (especially in patients with asthma/COPD)
- Cold hands and feet
- Depression, sleep disturbances
- Exacerbation of angina or arrhythmias upon abrupt discontinuation
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Propranolol crosses the placenta.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Propranolol is excreted into breast milk in small amounts. Monitor breastfed infant for signs of beta-blockade.
Pediatric Use
Propranolol ER is generally not recommended for pediatric use due to lack of established safety and efficacy. Immediate-release propranolol is used off-label for specific pediatric conditions (e.g., infantile hemangioma, hypertension, certain arrhythmias) with careful weight-based dosing and monitoring.
Geriatric Use
Geriatric patients may be more sensitive to the effects of beta-blockers and may have reduced hepatic clearance, leading to higher plasma concentrations. Initiate therapy with lower doses and titrate slowly. Monitor closely for bradycardia, hypotension, and CNS effects (e.g., confusion, depression).
Clinical Information
Clinical Pearls
- Propranolol ER is taken once daily, ideally at the same time each day, to maintain consistent drug levels.
- Do not crush, chew, or open the extended-release capsules; they must be swallowed whole.
- Patients with a history of asthma, severe COPD, or other bronchospastic diseases should generally avoid propranolol due to its non-selective beta-blocking effects.
- Use with extreme caution in patients with diabetes, as it can mask symptoms of hypoglycemia and prolong hypoglycemic episodes.
- Patients should be advised not to abruptly discontinue propranolol due to the risk of rebound hypertension, angina exacerbation, or myocardial infarction.
- Can cause cold extremities due to peripheral vasoconstriction.
Alternative Therapies
- 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-1 blockers (e.g., prazosin, doxazosin)