Inderal XL 80mg Capsules

Manufacturer ANI Active Ingredient Propranolol Sustained-Release Bead Capsules(proe PRAN oh lole) Pronunciation IN-der-al EKS-EL (Proe-PRAN-oh-lole)
It is used to treat high blood pressure.
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Drug Class
Antihypertensive, Antianginal, Antiarrhythmic, 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
Sep 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Inderal XL is a type of medicine called a beta-blocker. It works by relaxing blood vessels and slowing your heart rate, which helps to lower blood pressure, prevent chest pain (angina), and reduce the frequency of migraine headaches. It's an extended-release capsule, meaning it releases the medicine slowly over 24 hours, so you usually take it only once a day.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, but it's essential to take it the same way each time. If you choose to take it with food, always take it with food. If you prefer to take it on an empty stomach, always take it that way. If you're taking this medication once a day, take it at bedtime.

When taking the capsule, swallow it whole. Do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel well.

Storing and Disposing of Your Medication

To maintain the quality and effectiveness of your medication, store it at room temperature. Avoid freezing, and protect it from heat, cold, and light. Keep the lid tightly closed when not in use.

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

  • Take your medicine exactly as prescribed, usually once a day at the same time.
  • Do not crush, chew, or open the capsule; swallow it whole.
  • Do not stop taking this medicine suddenly, especially if you have heart disease, as it can worsen your condition. Your doctor will tell you how to slowly reduce the dose if needed.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase the effects of propranolol.
  • Maintain a healthy diet, exercise regularly (as advised by your doctor), and manage stress to support your heart health.
  • 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: 80 mg once daily
Dose Range: 80 - 240 mg

Condition-Specific Dosing:

hypertension: Initial 80 mg once daily; may increase to 120-160 mg once daily for optimal blood pressure control.
anginaPectoris: Initial 80 mg once daily; may increase to 160 mg once daily.
migraineProphylaxis: Initial 80 mg once daily; may increase to 160-240 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for Inderal XL; immediate-release propranolol may be used for specific indications (e.g., infantile hemangioma, certain arrhythmias) with weight-based dosing.
Adolescent: Not established for Inderal XL; immediate-release propranolol may be used for specific indications.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for exaggerated effects. Propranolol is extensively metabolized, and metabolites may accumulate.
Dialysis: Propranolol is not significantly removed by hemodialysis. No supplemental dose needed post-dialysis, but monitor for effects.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Consider dose reduction (e.g., 50%) and monitor for exaggerated effects due to reduced metabolism.
Severe: Significant dose reduction (e.g., 75%) is often required due to extensive first-pass metabolism and reduced clearance. Monitor closely for bradycardia and hypotension.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks both beta-1 (β1) and beta-2 (β2) adrenergic receptors. This blockade leads to decreased heart rate, myocardial contractility, and cardiac output (β1 blockade). It also inhibits renin release from the kidneys. β2 blockade can cause bronchoconstriction and peripheral vasoconstriction. The antihypertensive effect is thought to be due to reduced cardiac output, inhibition of renin release, and central nervous system effects.
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Pharmacokinetics

Absorption:

Bioavailability: 11-60% (highly variable due to extensive first-pass metabolism); extended-release formulation aims for smoother plasma levels.
Tmax: Approximately 6 hours (for Inderal XL).
FoodEffect: Food increases the bioavailability of propranolol.

Distribution:

Vd: Approximately 4 L/kg.
ProteinBinding: 90-95% (primarily to alpha1-acid glycoprotein and albumin).
CnssPenetration: Yes (lipophilic, readily crosses the blood-brain barrier).

Elimination:

HalfLife: Approximately 8-11 hours (for Inderal XL).
Clearance: Highly variable, dependent on hepatic blood flow and metabolic capacity.
ExcretionRoute: Renal (primarily as metabolites).
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 1-2 hours (for immediate-release); slower for extended-release.
PeakEffect: 6-12 hours (for Inderal XL).
DurationOfAction: 24 hours (for Inderal XL).

Safety & Warnings

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BLACK BOX WARNING

Abrupt Cessation of Therapy: Do not discontinue Inderal XL therapy abruptly, especially in patients with ischemic heart disease. Severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias have occurred following abrupt discontinuation of beta-blocker therapy. When discontinuing chronically administered Inderal XL, 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, Inderal XL administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Because coronary artery disease is common and may be unrecognized, it may be prudent to discontinue Inderal XL therapy slowly even in patients treated only for hypertension.
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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 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
+ Trouble 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
+ Feeling weak
+ Shaking
+ Fast 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
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. 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

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)
  • Difficulty breathing, wheezing, or shortness of breath (especially if new or worsening)
  • Swelling in your hands, ankles, or feet
  • Unusual weight gain
  • New or worsening chest pain
  • Extreme tiredness or weakness
  • Coldness, numbness, or tingling in your fingers and toes
  • Signs of depression (e.g., persistent sadness, loss of interest in activities)
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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 you experienced, including any symptoms that occurred.
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 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 your safety, inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
All your health problems

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.
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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 tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 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 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 low blood sugar, particularly in people 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 stop taking this medication abruptly, as this can lead to worsened chest pain or even heart attack, especially if you have certain types of heart disease. To avoid side effects, your doctor will guide you on how to gradually stop taking this 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 an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. If you have high blood pressure, consult your doctor before using over-the-counter 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 and Emergency Treatment
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 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.
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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 atropine for bradycardia, glucagon, IV fluids, vasopressors, and bronchodilators.

Drug Interactions

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Major Interactions

  • Non-dihydropyridine Calcium Channel Blockers (e.g., verapamil, diltiazem): Increased risk of severe bradycardia, heart block, and heart failure.
  • Other Beta-Blockers (including ophthalmic): Additive effects leading to severe bradycardia or hypotension.
  • Clonidine: Risk of rebound hypertension upon abrupt withdrawal of clonidine if propranolol is not also tapered.
  • Digoxin: Increased risk of bradycardia.
  • Amiodarone: Increased risk of bradycardia and AV block.
  • Insulin and Oral Hypoglycemics: May mask symptoms of hypoglycemia (e.g., tachycardia, palpitations) and prolong hypoglycemic episodes.
  • MAO Inhibitors: Potential for significant hypertension or bradycardia.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of propranolol.
  • CYP450 Inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine, ritonavir): May increase propranolol plasma concentrations.
  • CYP450 Inducers (e.g., rifampin, phenobarbital, phenytoin): May decrease propranolol plasma concentrations.
  • Alpha-1 Blockers (e.g., prazosin, doxazosin): Increased risk of orthostatic hypotension.
  • Sympathomimetics (e.g., epinephrine, norepinephrine): May cause unopposed alpha-adrenergic stimulation leading to hypertension and bradycardia.
  • Ergot Alkaloids: Increased risk of peripheral ischemia due to unopposed alpha-adrenergic vasoconstriction.
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Minor Interactions

  • Alcohol: May increase propranolol levels.
  • Antacids (e.g., aluminum hydroxide, magnesium hydroxide): May decrease propranolol absorption.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension/angina.

Timing: Prior to initiation.

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia, a common adverse effect.

Timing: Prior to initiation.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block).

Timing: Prior to initiation, especially in patients with cardiac history.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, as metabolites are renally excreted.

Timing: Prior to initiation.

Hepatic Function (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, as propranolol is extensively metabolized by the liver.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly during dose titration, then monthly/quarterly once stable).

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

Action Threshold: Hypotension (e.g., systolic <90 mmHg or symptomatic), or inadequate control.

Heart Rate (HR)

Frequency: Regularly (e.g., weekly during dose titration, then monthly/quarterly once stable).

Target: Typically >50-60 bpm (unless target bradycardia for specific conditions).

Action Threshold: Bradycardia (<50 bpm or symptomatic), or significant drop from baseline.

Symptoms of Heart Failure

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: New or worsening dyspnea, edema, weight gain, fatigue.

Blood Glucose (in diabetic patients)

Frequency: Regularly, as per diabetes management guidelines.

Target: Individualized.

Action Threshold: Frequent or severe hypoglycemic episodes, especially if symptoms are masked.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue or lethargy
  • Shortness of breath or wheezing (especially in patients with asthma/COPD)
  • Cold hands or feet (Raynaud's phenomenon)
  • Depression or mood changes
  • Sleep disturbances or nightmares
  • Bradycardia (slow pulse)
  • Signs of heart failure (e.g., swelling in ankles/feet, sudden weight gain, increased shortness of breath)

Special Patient Groups

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Pregnancy

Propranolol is classified as Pregnancy Category C. While studies in animals have shown adverse effects, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data; potential for fetal growth restriction and congenital anomalies, though not definitively established.
Second Trimester: Potential for fetal bradycardia, hypoglycemia, and growth restriction.
Third Trimester: Increased risk of fetal/neonatal bradycardia, hypoglycemia, respiratory depression, and growth restriction. Neonates should be monitored for signs of beta-blockade for several days after birth.
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Lactation

Propranolol is excreted into breast milk. The American Academy of Pediatrics considers it 'compatible with breastfeeding' but advises monitoring the infant. The risk category is L3 (Moderately Safe).

Infant Risk: Monitor breastfed infants for signs of beta-blockade, including bradycardia, hypotension, and hypoglycemia. The amount transferred to milk is generally low, but caution is advised, especially in premature or sick infants.
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Pediatric Use

Safety and effectiveness of Inderal XL in pediatric patients have not been established. Immediate-release propranolol is used off-label for certain pediatric conditions (e.g., infantile hemangioma, certain arrhythmias), but specific dosing for the extended-release formulation is not well-defined for general pediatric use.

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Geriatric Use

Elderly patients may be more sensitive to the effects of beta-blockers and may experience increased adverse effects (e.g., bradycardia, dizziness, orthostatic hypotension). Initiate therapy with lower doses and titrate slowly, monitoring closely for adverse reactions and therapeutic response. Renal and hepatic function should be considered.

Clinical Information

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Clinical Pearls

  • Always taper propranolol slowly over 1-2 weeks to avoid rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with ischemic heart disease.
  • Propranolol is non-selective, meaning it blocks both beta-1 and beta-2 receptors. This can lead to bronchoconstriction, so it should be used with extreme caution or avoided in patients with asthma, COPD, or other bronchospastic diseases.
  • Can mask symptoms of hypoglycemia (e.g., tachycardia, tremors) in diabetic patients, making it harder to recognize low blood sugar. Educate diabetic patients to monitor blood glucose closely.
  • May exacerbate symptoms of peripheral vascular disease (e.g., Raynaud's phenomenon) due to beta-2 blockade leading to vasoconstriction.
  • Take Inderal XL consistently, preferably with food, to ensure consistent absorption and reduce variability.
  • Patients should be advised to report any new or worsening shortness of breath, swelling, or significant fatigue, which could indicate heart failure.
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Alternative Therapies

  • Other Beta-Blockers (e.g., Metoprolol, Atenolol, Carvedilol, Bisoprolol)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Calcium Channel Blockers (e.g., Amlodipine, Nifedipine, Diltiazem, Verapamil)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Alpha-Blockers (e.g., Prazosin, Doxazosin)
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Cost & Coverage

Average Cost: Varies widely (e.g., $30-$150+) per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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General Drug Facts

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 details. If you have any questions or concerns about this 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 information about the medication taken, the amount, and the time it happened.