Inderal XL 120mg Capsules

Manufacturer ANI Active Ingredient Propranolol Sustained-Release Bead Capsules(proe PRAN oh lole) Pronunciation proe PRAN oh lole
It is used to treat high blood pressure.
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Drug Class
Antihypertensive, Antianginal, Antimigraine
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Pharmacologic Class
Non-selective beta-adrenergic blocker
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Pregnancy Category
Not available
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FDA Approved
Sep 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol extended-release 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, reduce chest pain (angina), and prevent migraines. The 'XL' means it's a long-acting form, 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 with your prescription 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 on an empty stomach.

If you're taking this medication once a day, it's best to take it at bedtime. Swallow the capsule 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. It's crucial to maintain your treatment regimen to achieve the best results.

Storing and Disposing of Your Medication

To keep your medication effective, store it at room temperature. Avoid freezing, and protect it from heat, cold, and light. Keep the lid tightly closed to maintain the medication's potency.

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 the medication at the same time each day, preferably in the morning.
  • Swallow the capsule whole; do not crush, chew, or open it.
  • Do not stop taking this medication suddenly, especially if you have heart disease, as it can worsen your condition. Your doctor will tell you how to gradually reduce the dose.
  • Avoid excessive alcohol consumption, as it can increase the effects of propranolol.
  • Maintain a healthy diet, regular exercise, and manage stress to support blood pressure control.
  • 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: 120 mg orally once daily
Dose Range: 80 - 160 mg

Condition-Specific Dosing:

hypertension: Initial: 80 mg orally once daily; may increase to 120 mg, then 160 mg once daily at 3-7 day intervals. Max: 160 mg/day.
angina_pectoris: Initial: 80 mg orally once daily; may increase to 120 mg, then 160 mg once daily at 3-7 day intervals. Max: 160 mg/day.
migraine_prophylaxis: Initial: 80 mg orally once daily; may increase to 120 mg, then 160 mg once daily at 3-7 day intervals. Max: 160 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for extended-release formulation. Immediate-release formulation may be used for specific indications (e.g., infantile hemangioma) with different dosing.
Adolescent: Not established for extended-release formulation. Immediate-release formulation may be used for specific indications.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically needed.
Moderate: No dosage adjustment typically needed, but monitor for increased effects.
Severe: Use with caution. Consider lower initial doses and careful titration. Monitor for increased effects.
Dialysis: Propranolol is not significantly dialyzable. No specific supplemental dose needed, but monitor for increased effects due to potential accumulation of metabolites.

Hepatic Impairment:

Mild: Use with caution. Consider lower initial doses.
Moderate: Significant dosage reduction may be necessary due to reduced metabolism. Monitor heart rate and blood pressure closely.
Severe: Contraindicated in severe hepatic dysfunction (e.g., decompensated cirrhosis) due to risk of profound bradycardia and hypotension. If used, extreme caution and significant dose reduction required.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks beta-1 (myocardial) and beta-2 (bronchial and vascular) adrenergic receptors. This leads to decreased heart rate, decreased myocardial contractility, decreased cardiac output, and reduced blood pressure. It also inhibits renin release from the kidneys. In migraine prophylaxis, its mechanism is not fully understood but may involve modulation of cerebral blood flow and inhibition of beta-adrenergic receptors in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25% (due to extensive first-pass metabolism); extended-release formulation provides sustained absorption.
Tmax: 6 hours (for extended-release formulation)
FoodEffect: Food may increase bioavailability, but consistent administration relative to meals is recommended.

Distribution:

Vd: 4 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes

Elimination:

HalfLife: 8-11 hours (for extended-release formulation)
Clearance: Not available (highly variable due to first-pass metabolism)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for extended-release, effects are sustained)
PeakEffect: 6-12 hours (for extended-release)
DurationOfAction: 24 hours (for extended-release)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

BRADYCARDIA, HYPOTENSION, BRONCHOSPASM, AND HEART FAILURE. Abrupt discontinuation of propranolol therapy in patients with coronary artery disease may exacerbate angina, precipitate myocardial infarction, or ventricular arrhythmias. When discontinuing chronically administered propranolol, 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, propranolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue propranolol therapy abruptly 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 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 other 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.
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Seek Immediate Medical Attention If You Experience:

  • Very slow heart rate (less than 50 beats per minute)
  • Dizziness, lightheadedness, or fainting
  • Shortness of breath, wheezing, or difficulty breathing (especially if new or worsening)
  • Swelling in your ankles or feet, unusual weight gain, or increased fatigue (signs of heart failure)
  • Coldness, numbness, or tingling in your hands or feet
  • Severe depression or unusual mood changes
  • Symptoms of low blood sugar (e.g., sweating, shakiness, hunger) may be masked, so monitor blood sugar closely if you have diabetes.
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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. Be sure to describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ 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, including:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:

Medications (prescription and over-the-counter)
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 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 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. This medication may mask symptoms of low blood sugar, such as a 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 stop taking this medication abruptly, as this can lead to worsening 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, contact your doctor 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 with your doctor if you have any concerns.

Interactions with Other Medications
If you have high blood pressure, talk to 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.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Profound hypotension (very low blood pressure)
  • Cardiogenic shock
  • Congestive heart failure
  • Bronchospasm
  • Hypoglycemia
  • Seizures
  • Coma

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Treatment may involve atropine for bradycardia, glucagon, intravenous fluids, vasopressors, and bronchodilators.

Drug Interactions

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Contraindicated Interactions

  • 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)
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Major Interactions

  • Other beta-blockers (additive effects)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal)
  • Digoxin (additive bradycardia)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • Alpha-1 blockers (e.g., prazosin, doxazosin) (risk of orthostatic hypotension)
  • Antipsychotics (e.g., thioridazine) (increased propranolol levels)
  • Fingolimod (risk of severe bradycardia)
  • Sympathomimetics (e.g., epinephrine, norepinephrine) (unopposed alpha-adrenergic stimulation, leading to hypertension and bradycardia)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Cimetidine (increased propranolol levels)
  • Fluoxetine, paroxetine (increased propranolol levels via CYP2D6 inhibition)
  • Rifampin (decreased propranolol levels)
  • Alcohol (may increase propranolol levels)
  • Lidocaine (increased lidocaine levels)
  • Theophylline (decreased theophylline clearance)
  • Warfarin (potential for altered INR)
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Minor Interactions

  • Antacids (may decrease absorption of propranolol)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia.

Timing: Prior to initiation

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 (SCr, BUN)

Rationale: To assess kidney function, especially in elderly or those with risk factors for renal impairment.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, bilirubin)

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

Timing: Prior to initiation

Blood Glucose

Rationale: To establish baseline, especially in diabetic patients, due to potential for masking hypoglycemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Systolic >140 mmHg or Diastolic >90 mmHg (consider dose adjustment); Symptomatic hypotension (consider dose reduction)

Heart Rate (HR)

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

Target: 50-60 bpm (resting)

Action Threshold: <50 bpm or symptomatic bradycardia (consider dose reduction/discontinuation)

Blood Glucose

Frequency: Periodically, especially in diabetic patients

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes (consider alternative or adjust diabetes medication)

Symptoms of Heart Failure

Frequency: Ongoing clinical assessment

Target: Absence of new or worsening symptoms

Action Threshold: Worsening dyspnea, edema, weight gain (evaluate for heart failure exacerbation)

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Symptom Monitoring

  • Bradycardia (slow pulse)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, weakness
  • Cold hands/feet
  • Bronchospasm (wheezing, shortness of breath)
  • Depression, sleep disturbances
  • Masked symptoms of hypoglycemia (in diabetics)
  • Worsening of peripheral vascular disease symptoms
  • Signs of heart failure (e.g., dyspnea, edema, weight gain)

Special Patient Groups

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Pregnancy

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. Monitor neonates for these effects.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. Monitor neonate for 24-48 hours after birth.
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Lactation

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). Considered L3 (moderately safe) by LactMed.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, drowsiness, and hypoglycemia.
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Pediatric Use

Safety and efficacy of Inderal XL (propranolol extended-release) have not been established in pediatric patients. Immediate-release propranolol is used off-label for certain pediatric conditions, but dosing and monitoring differ significantly.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Propranolol is a non-selective beta-blocker, meaning it blocks both beta-1 and beta-2 receptors. This can lead to bronchoconstriction (contraindicated in asthma/COPD) and masking of hypoglycemia symptoms.
  • The extended-release formulation (Inderal XL) is designed for once-daily dosing, improving patient adherence.
  • Abrupt discontinuation can lead to rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with ischemic heart disease. Taper dose gradually over 1-2 weeks.
  • Use with caution in patients with diabetes, as it can mask signs of hypoglycemia (e.g., tremor, palpitations) and prolong hypoglycemic episodes.
  • Avoid concomitant use with non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) due to increased risk of severe bradycardia and heart block.
  • Can cause or worsen peripheral vascular disease symptoms due to vasoconstriction.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin receptor blockers (ARBs) (e.g., valsartan, losartan)
  • Calcium channel blockers (e.g., amlodipine, nifedipine)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • For migraine prophylaxis: Topiramate, valproic acid, CGRP inhibitors (e.g., erenumab, fremanezumab)
  • For angina: Nitrates, ranolazine
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Cost & Coverage

Average Cost: $30 - $150 per 30 capsules (120mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (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 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.