Inderal LA 80mg Capsules

Manufacturer ANI PHARMACEUTICALS 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, Antianginal, Antimigraine
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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
Jun 1973
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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 your heart rate, which helps lower blood pressure, reduce chest pain (angina), prevent migraines, and control tremors. It's a long-acting capsule, so you usually take it once a day.
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How to Use This Medicine

Taking Your Medication Correctly

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 capsules, swallow them whole without chewing, breaking, or crushing them.

Continuing Your Medication Regimen

It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help you achieve the best possible outcome from your treatment.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature, avoiding freezing temperatures.
Protect your medication from heat, cold, and light sources.
Keep the container 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

  • Do not stop taking this medication suddenly, especially if you have heart disease. Your doctor will tell you how to slowly reduce the dose.
  • Take your pulse and blood pressure regularly as advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase the effects of propranolol.
  • 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 signs of low blood sugar (hypoglycemia), such as a fast heartbeat. Monitor your blood sugar levels closely.
  • Avoid activities requiring mental alertness until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • Maintain a healthy diet, regular exercise (as advised by your doctor), and manage stress to support blood pressure control.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For hypertension, initial 80 mg once daily.
Dose Range: 80 - 640 mg

Condition-Specific Dosing:

Hypertension: Initial 80 mg once daily; usual effective range 120-160 mg once daily. Max 640 mg/day.
Angina Pectoris: Initial 80 mg once daily; usual effective range 160-320 mg once daily.
Migraine Prophylaxis: Initial 80 mg once daily; usual effective range 160-240 mg once daily.
Essential Tremor: Initial 80 mg once daily; usual effective range 120-320 mg once daily.
Hypertrophic Subaortic Stenosis: 80-160 mg once daily.
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., infantile hemangioma) may have specialized dosing.
Infant: Not established for routine use; specific indications (e.g., infantile hemangioma) may have specialized dosing.
Child: Dosing for hypertension or migraine prophylaxis is typically off-label or based on weight-based guidelines (e.g., 0.5-1 mg/kg/day divided, titrate up to 2-4 mg/kg/day). Inderal LA is generally not recommended for initial pediatric use due to sustained-release formulation.
Adolescent: Similar to adult dosing for specific indications, but start with lower doses and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for increased effects.
Severe: Use with caution; monitor for increased effects due to potential accumulation of metabolites. No specific dose reduction guidelines.
Dialysis: Propranolol is not significantly removed by hemodialysis. No specific supplemental dose needed, but monitor for effects.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor.
Moderate: Consider dose reduction (e.g., 50%) and monitor heart rate and blood pressure closely.
Severe: Significant dose reduction (e.g., 75%) is often required due to extensive hepatic metabolism. Titrate very slowly and monitor closely.

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 and has a central effect contributing to its use in migraine prophylaxis and essential tremor.
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Pharmacokinetics

Absorption:

Bioavailability: 25-50% (highly variable due to extensive first-pass metabolism)
Tmax: 6-12 hours (for sustained-release formulation)
FoodEffect: Food increases bioavailability and reduces variability in plasma concentrations.

Distribution:

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

Elimination:

HalfLife: 8-11 hours (for sustained-release formulation)
Clearance: Not readily available as a single rate, but primarily hepatic metabolism.
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for immediate release; sustained release is slower)
PeakEffect: 6-12 hours (for sustained-release formulation)
DurationOfAction: 24 hours (for sustained-release formulation)

Safety & Warnings

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BLACK BOX WARNING

DO NOT ABRUPTLY DISCONTINUE PROPRANOLOL. Exacerbation of angina pectoris, myocardial infarction, and ventricular arrhythmias have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. 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 to discontinue propranolol 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 immediately or seek emergency 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
+ 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, 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 if they bother you or do not go away:

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:

  • Very slow heart rate (less than 50 beats per minute)
  • Dizziness, lightheadedness, or fainting
  • Shortness of breath, wheezing, or difficulty breathing (especially if you have asthma or COPD)
  • Swelling in your ankles or feet, sudden weight gain, or unusual tiredness (signs of heart failure)
  • Severe depression or unusual mood changes
  • Coldness, numbness, or pain in your fingers or toes
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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

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & 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 using stairs.

Follow your doctor's instructions for monitoring your blood pressure and heart rate. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.

Before consuming alcohol, discuss it with your doctor. 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, particularly in individuals with diabetes, children, and those who are fasting or have undergone surgery. If you have questions or concerns, consult your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. 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 adverse 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.

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 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.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform 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 (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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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 severe hypertension).
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Major Interactions

  • Other beta-blockers (additive effects, severe bradycardia/hypotension).
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal).
  • Digoxin (additive bradycardia).
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia).
  • NSAIDs (may reduce antihypertensive effect of propranolol).
  • Alpha-1 blockers (e.g., prazosin, tamsulosin) (risk of profound postural hypotension).
  • Amiodarone (additive bradycardia, AV block).
  • Propafenone, flecainide (increased propranolol levels, additive negative inotropic/chronotropic effects).
  • Cimetidine, fluoxetine, paroxetine, quinidine (CYP2D6 inhibitors, increase propranolol levels).
  • Rifampin, phenobarbital, phenytoin (CYP inducers, decrease propranolol levels).
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Moderate Interactions

  • Alcohol (may increase propranolol levels).
  • Epinephrine (paradoxical hypertension and bradycardia).
  • Theophylline (reduced clearance of theophylline).
  • Lidocaine (reduced lidocaine clearance).
  • Warfarin (potential for altered INR, monitor closely).
  • SSRIs (other than fluoxetine/paroxetine) (potential for altered propranolol levels).
  • Aluminum hydroxide, cholestyramine (may reduce propranolol absorption).
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Minor Interactions

  • Antacids (may reduce absorption, separate administration).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

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

Timing: Prior to initiation of therapy.

Heart Rate (HR)

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

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block) that are contraindications or require caution.

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

Liver Function Tests (LFTs)

Rationale: Propranolol is extensively metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.

Timing: Prior to initiation, if clinically indicated.

Blood Glucose

Rationale: To establish baseline, particularly in diabetic patients, as propranolol can mask hypoglycemia symptoms.

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Systolic BP <90 mmHg or symptomatic hypotension; BP consistently above target.

Heart Rate (HR)

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

Target: Typically >50-60 bpm at rest (unless specific therapeutic goal is lower)

Action Threshold: HR <50 bpm or symptomatic bradycardia.

Symptoms of Heart Failure

Frequency: At each visit

Target: Absence of new or worsening symptoms

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

Blood Glucose (for diabetics)

Frequency: Regularly, as per diabetes management guidelines

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes.

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, lethargy
  • Shortness of breath, wheezing (especially in patients with asthma/COPD)
  • Cold hands and feet (peripheral vasoconstriction)
  • Depression, sleep disturbances, nightmares
  • Masked symptoms of hypoglycemia (in diabetics)
  • Signs of worsening heart failure (e.g., increased dyspnea, edema, weight gain)

Special Patient Groups

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Pregnancy

Propranolol is classified as 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/neonatal bradycardia, hypoglycemia, and respiratory depression. Growth retardation has also been reported.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed due to potential for fetal effects.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. 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 is generally low, but infants should be monitored for signs of beta-blockade (e.g., bradycardia, lethargy, hypoglycemia).

Infant Risk: Low to moderate. Potential for bradycardia, hypoglycemia, and respiratory depression in the infant, especially in premature infants or those with impaired renal/hepatic function. Monitor infant for these effects.
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Pediatric Use

Safety and efficacy of Inderal LA in pediatric patients have not been established for all indications. Dosing for hypertension or migraine prophylaxis is often off-label and requires careful titration based on weight and response. Due to the sustained-release nature, it may not be suitable for initial titration in younger children. Close monitoring for adverse effects is crucial.

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Geriatric Use

Elderly patients may be more sensitive to the effects of beta-blockers and may have reduced hepatic or renal function, which can affect drug clearance. Start with lower doses and titrate slowly. Monitor heart rate, blood pressure, and for signs of adverse effects (e.g., bradycardia, hypotension, fatigue, confusion) more closely.

Clinical Information

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Clinical Pearls

  • Always emphasize the black box warning regarding abrupt discontinuation, especially in patients with coronary artery disease.
  • Propranolol is non-selective, meaning it blocks both beta-1 and beta-2 receptors. This can lead to bronchoconstriction (contraindicated in asthma/severe COPD) and masking of hypoglycemia symptoms in diabetics.
  • The sustained-release (LA) formulation is designed for once-daily dosing, improving adherence.
  • Food increases the bioavailability of propranolol, so consistent administration with meals is often recommended to reduce variability.
  • Monitor for signs of depression, as beta-blockers can sometimes exacerbate or induce depressive symptoms.
  • Patients may experience cold extremities due to peripheral vasoconstriction; advise on appropriate clothing.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol - some are cardioselective)
  • 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)
  • Alpha-blockers (e.g., prazosin, doxazosin)
  • Central alpha-agonists (e.g., clonidine)
  • For migraine prophylaxis: Topiramate, valproic acid, CGRP inhibitors, tricyclic antidepressants.
  • For essential tremor: Primidone.
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 30 capsules (80mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.