Inderal LA 160mg Capsules

Manufacturer ANI Active Ingredient Propranolol Sustained-Release Capsules(proe PRAN oh lole) Pronunciation proe PRAN oh lole
It is used to treat high blood pressure.It is used to treat chest pain or pressure. It is used to help certain heart problems.It is used to prevent migraine headaches.
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Drug Class
Antihypertensive, Antiarrhythmic, Antianginal, Migraine Prophylaxis
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Pharmacologic Class
Non-selective Beta-Adrenergic Blocker
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Pregnancy Category
Category C
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FDA Approved
Nov 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a type of medicine called a beta-blocker. It works by relaxing blood vessels and slowing down your heart rate, which helps to lower high blood pressure, prevent chest pain (angina), and reduce the frequency of migraine headaches. It can also help with tremors and certain heart conditions.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you 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. Some medications are best taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.

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

Storing and Disposing of Your Medication

To maintain the effectiveness of your medication, store it at room temperature, away from heat, cold, and light. Keep the container tightly closed and do not freeze.

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 a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily. Do not crush, chew, or open the capsule.
  • 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.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase the levels of propranolol in your body.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • If you have diabetes, be aware that propranolol can mask the symptoms of low blood sugar (hypoglycemia), such as a fast heartbeat or shakiness. Monitor your blood sugar closely.
  • Avoid activities requiring mental alertness if you experience dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: 160 mg once daily (for Inderal LA 160mg)
Dose Range: 80 - 320 mg

Condition-Specific Dosing:

hypertension: 80 mg once daily initially, may increase to 120-160 mg once daily. Max 640 mg/day.
angina_pectoris: 80 mg once daily initially, may increase to 160 mg once daily. Max 320 mg/day.
migraine_prophylaxis: 80 mg once daily initially, may increase to 160-240 mg once daily.
essential_tremor: 80 mg once daily initially, may increase to 120-320 mg once daily.
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Pediatric Dosing

Neonatal: Not established for sustained-release formulation. Immediate-release used off-label for infantile hemangioma (dosing varies by indication and weight).
Infant: Not established for sustained-release formulation. Immediate-release used off-label for infantile hemangioma (dosing varies by indication and weight).
Child: Not established for sustained-release formulation. Immediate-release used off-label for various conditions (e.g., hypertension, migraine prophylaxis, hypertrophic subaortic stenosis). Dosing is weight-based.
Adolescent: Not established for sustained-release formulation. Immediate-release used off-label for various conditions. For hypertension, 80-160 mg once daily of LA formulation may be considered if immediate-release is tolerated and appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution. Accumulation of metabolites may occur. Consider lower initial doses and careful titration.
Dialysis: Propranolol is not significantly dialyzable. No specific supplemental dose needed, but use with caution due to potential for metabolite accumulation.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant reduction in dosage may be necessary due to extensive hepatic metabolism. Start with lower doses (e.g., 50% of usual) and titrate slowly.
Severe: Contraindicated or use with extreme caution. Significant reduction in dosage is required. Monitor closely for adverse effects.
Confidence: Medium

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 smooth muscle) 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. Its anti-migraine effect is thought to be due to its ability to block beta-receptors in the cerebral vasculature and/or central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25% (highly variable due to extensive first-pass metabolism). Sustained-release formulation provides more consistent absorption.
Tmax: 6-16 hours for sustained-release capsules.
FoodEffect: Food may increase bioavailability and reduce variability, especially for immediate-release. Sustained-release formulation absorption is not significantly affected by food.

Distribution:

Vd: 4 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes (highly lipophilic, readily crosses blood-brain barrier)

Elimination:

HalfLife: Approximately 8-11 hours for sustained-release formulation (due to prolonged absorption). Immediate-release is 3-6 hours.
Clearance: Approximately 0.16 L/hr/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Less than 1% (immediate-release); negligible for sustained-release
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for blood pressure reduction with sustained-release)
PeakEffect: 6-16 hours (for sustained-release)
DurationOfAction: 24 hours (for sustained-release)

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABRUPT CESSATION OF THERAPY. Exacerbation of angina pectoris and, in some cases, myocardial infarction and ventricular arrhythmia have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. Therefore, 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 pectoris 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 immediate medical attention:

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 a rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ A 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
Unusual burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red) on the hands, feet, or other areas
Changes in vision
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. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness, drowsiness, tiredness, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Difficulty sleeping
Strange or vivid dreams

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 you have asthma or COPD)
  • Swelling in your ankles or feet, sudden weight gain, or unusual tiredness (signs of heart failure)
  • Coldness, numbness, or pain in your fingers or toes
  • Severe depression or unusual mood changes
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 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
Your complete medical history, including any health problems you have or have had

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

Regularly monitor your blood pressure and heart rate as instructed by your doctor. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, talk to your doctor about the potential interactions with this medication. Smoking may mask symptoms of low blood sugar, such as a 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 nausea and vomiting.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. If you have any questions or concerns, consult your doctor.

Do not abruptly stop taking this medication, as this may lead to worsened chest pain or even a heart attack, especially in individuals with certain types of heart disease. To minimize the risk of 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, seek medical attention immediately.

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.

If you have high blood pressure and are taking this medication, 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.

If you have a history of severe allergic reactions, discuss the potential risks with your doctor. You may be more susceptible to 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.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks 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
  • Hypoglycemia
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call 911. 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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Contraindicated Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, heart block, heart failure
  • MAO inhibitors - risk of severe hypertension (though less direct interaction, caution with adrenergic agents)
  • Thioridazine - increased thioridazine levels, risk of QT prolongation and arrhythmias
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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) - risk of severe orthostatic hypotension
  • Fingolimod (risk of severe bradycardia)
  • Amiodarone (risk of bradycardia, heart block)
  • Propafenone, Quinidine, Fluoxetine, Paroxetine (CYP2D6 inhibitors - increased propranolol levels)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Sympathomimetics (e.g., epinephrine, norepinephrine, pseudoephedrine) - risk of hypertension and bradycardia
  • Cimetidine (increased propranolol levels)
  • Alcohol (increased propranolol levels)
  • Rifampin, Phenobarbital, Phenytoin (CYP inducers - decreased propranolol levels)
  • Lidocaine (increased lidocaine levels)
  • Theophylline (mutual inhibition of clearance)
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Minor Interactions

  • Antacids (may decrease absorption of immediate-release, less relevant for LA)
  • Cholestyramine/Colestipol (may decrease absorption)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

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

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess risk of bradycardia.

Timing: Prior to initiation

ECG

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

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

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function and guide dose adjustments in severe impairment.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess liver function and guide dose adjustments in hepatic impairment.

Timing: Prior to initiation

Blood Glucose

Rationale: To establish baseline, especially in diabetic patients, due to risk of masked hypoglycemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent BP above target or symptomatic hypotension

Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: 50-70 bpm (resting)

Action Threshold: Persistent HR <50 bpm or symptomatic bradycardia

Symptoms of Heart Failure

Frequency: Regularly

Target: Absence of new or worsening symptoms

Action Threshold: Dyspnea, edema, weight gain, fatigue

Blood Glucose

Frequency: Regularly, especially in diabetic patients

Target: Individualized

Action Threshold: Hypoglycemia (especially if masked)

Respiratory Status

Frequency: Regularly, especially in patients with asthma/COPD

Target: Absence of bronchospasm

Action Threshold: Wheezing, shortness of breath

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Symptom Monitoring

  • Bradycardia (slow pulse)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, weakness
  • Cold hands/feet
  • Bronchospasm (wheezing, shortness of breath)
  • Symptoms of heart failure (dyspnea, edema, weight gain)
  • Masked hypoglycemia (sweating, tremor, palpitations may be absent)
  • Depression, sleep disturbances
  • Sexual dysfunction

Special Patient Groups

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Pregnancy

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 fetal growth restriction, bradycardia, and hypoglycemia. Neonates exposed to beta-blockers in utero may be at risk for hypoglycemia, bradycardia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed. Potential for fetal growth restriction.
Second Trimester: Risk of fetal growth restriction, bradycardia, and hypoglycemia. Close monitoring of fetal growth and heart rate is recommended.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression at birth. Withdrawal symptoms (e.g., irritability, tremors) may occur in the neonate. Discontinuation or dose reduction prior to delivery may be considered if clinically appropriate.
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Lactation

Propranolol is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it 'compatible with breastfeeding'. The risk to the infant is generally low, but monitor for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding, hypoglycemia).

Infant Risk: L2 (Safer). Low risk of adverse effects in breastfed infants. Monitor for bradycardia, hypotension, and hypoglycemia, especially in neonates or premature infants.
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Pediatric Use

Safety and effectiveness of sustained-release propranolol (Inderal LA) have not been established in pediatric patients. Immediate-release propranolol is used off-label in pediatric populations for various indications (e.g., hypertension, migraine prophylaxis, infantile hemangioma), with dosing based on weight and indication. Close monitoring for adverse effects is crucial.

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Geriatric Use

Elderly patients may be more sensitive to the effects of propranolol, particularly bradycardia and hypotension. Start with lower doses and titrate slowly. Renal and hepatic function should be assessed, as age-related decline in these functions may necessitate dose adjustments.

Clinical Information

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Clinical Pearls

  • Propranolol LA is a once-daily formulation, improving adherence compared to immediate-release.
  • Always taper propranolol gradually over 1-2 weeks to avoid rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with ischemic heart disease.
  • Non-selective beta-blockers like propranolol should be used with extreme caution or avoided in patients with asthma, severe COPD, or other bronchospastic diseases due to the risk of bronchoconstriction.
  • Can mask symptoms of hypoglycemia in diabetic patients, except for sweating.
  • May cause cold extremities due to peripheral vasoconstriction.
  • Effective for performance anxiety due to its ability to block peripheral adrenergic symptoms (e.g., tremor, palpitations).
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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., losartan, valsartan)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine, felodipine)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • For migraine prophylaxis: Topiramate, Valproic acid, CGRP inhibitors
  • For essential tremor: Primidone
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100+ per 30 capsules
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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.