Inderal LA 120mg 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, Antianginal, Antimigraine, Antiarrhythmic
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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
Jun 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol LA is a type of medicine called a beta-blocker. It works by relaxing blood vessels and slowing your heart rate, which helps to lower high blood pressure, prevent chest pain (angina), reduce the frequency of migraine headaches, and lessen tremors. The 'LA' means 'long-acting', so you usually take it only 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.
Swallow the capsule whole; do not chew, break, or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

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

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take medication consistently at the same time each day.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase side effects.
  • Avoid activities requiring mental alertness until you know how the medication affects you (e.g., driving).
  • Maintain a healthy diet, regular exercise, and manage stress to support cardiovascular 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: 120 mg orally once daily
Dose Range: 80 - 160 mg

Condition-Specific Dosing:

hypertension: 80 mg to 160 mg orally once daily; may increase to 120 mg or 160 mg once daily for optimal control.
anginaPectorisProphylaxis: 80 mg orally once daily; may increase to 120 mg or 160 mg once daily for optimal control.
migraineProphylaxis: 80 mg orally once daily; may increase to 120 mg or 160 mg once daily for optimal control.
essentialTremor: 80 mg orally once daily; may increase to 120 mg or 160 mg once daily for optimal control.
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Pediatric Dosing

Neonatal: Not established for LA formulation; immediate-release propranolol is used for specific conditions (e.g., infantile hemangioma).
Infant: Not established for LA formulation; immediate-release propranolol is used for specific conditions (e.g., infantile hemangioma).
Child: Not established for LA formulation; immediate-release propranolol is used for specific conditions.
Adolescent: Not established for LA formulation; immediate-release propranolol is used for specific conditions.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant reduction in dose may be required (e.g., 50% reduction). Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution at significantly reduced doses (e.g., 75% reduction or more). Monitor closely for adverse effects.

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 results in decreased heart rate, decreased myocardial contractility, decreased cardiac output, and reduced blood pressure. It also inhibits renin release from the kidneys. Its antimigraine effect is thought to be related to its ability to block beta-receptors in the cerebral vasculature and/or central nervous system. Its anti-tremor effect is likely due to blockade of peripheral beta-2 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25% (due to extensive first-pass metabolism); LA formulation provides sustained release.
Tmax: 6 hours (for LA formulation)
FoodEffect: Food can increase bioavailability, but the effect is less pronounced with the LA formulation compared to immediate-release. Consistent administration with or without food is recommended.

Distribution:

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

Elimination:

HalfLife: 10-20 hours (for LA formulation, due to sustained release)
Clearance: Approximately 0.16 L/hr/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for LA formulation, initial effect)
PeakEffect: 6-12 hours (for LA formulation)
DurationOfAction: 24 hours (for LA formulation)
Confidence: Medium

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 follow the above advice in patients considered at risk of occult atherosclerotic heart disease.
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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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 other 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, 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 Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical help 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

This is not an exhaustive list of possible 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 new or worsening shortness of breath
  • Swelling in your ankles, feet, or hands
  • Unusual weight gain
  • Chest pain or discomfort (especially if you stop the medication suddenly)
  • Severe fatigue or weakness
  • Signs of depression (e.g., persistent sadness, loss of interest)
  • Coldness, numbness, or tingling in your hands or feet
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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 symptoms you experienced.
Certain heart conditions, including:
+ Abnormal heart rhythms (heart block or sick-sinus syndrome)
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to your arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
* Respiratory issues, such as:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

This list is not exhaustive, and it is crucial to discuss all your 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

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 alertness. 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 some 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 have undergone surgery.

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 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 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 taking 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.

Allergic Reactions and Epinephrine
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 epinephrine may be less effective while taking this medication.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of taking 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.

Drug Interactions

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Contraindicated Interactions

  • MAO inhibitors (risk of severe hypertension)
  • Thioridazine (increased thioridazine levels, risk of QT prolongation and arrhythmias)
  • Diazoxide (enhanced hypotensive effect)
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Major Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem - risk of severe bradycardia, heart block, heart failure)
  • Digoxin (additive bradycardia)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered first)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • Sympathomimetics (e.g., epinephrine, norepinephrine - unopposed alpha-adrenergic stimulation, severe hypertension, bradycardia)
  • Fingolimod (additive bradycardia)
  • Prazosin (first-dose syncope risk)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Phenytoin, phenobarbital, rifampin (may decrease propranolol levels)
  • Cimetidine, fluoxetine, paroxetine, quinidine (may increase propranolol levels)
  • Lidocaine (increased lidocaine levels)
  • Warfarin (potential for altered INR, monitor closely)
  • Alcohol (additive CNS depression, increased propranolol levels)
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Minor Interactions

  • Antacids (may decrease propranolol absorption, separate administration)
  • Tobacco smoking (may decrease propranolol levels)

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.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities.

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

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, especially important for dose adjustments in severe impairment.

Timing: Prior to initiation.

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, critical for dose adjustments in hepatic impairment.

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 initially, then monthly or quarterly once stable)

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

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

Heart Rate (HR)

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

Target: 50-60 bpm (resting)

Action Threshold: <50 bpm or symptomatic bradycardia.

Symptoms of Heart Failure

Frequency: At each visit

Target: Absence of new or worsening symptoms

Action Threshold: Development of dyspnea, edema, weight gain.

Blood Glucose (in diabetics)

Frequency: Regularly, as per diabetes management plan

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Bradycardia (slow heart rate)
  • Dyspnea (shortness of breath)
  • Wheezing (bronchospasm)
  • Cold extremities
  • Depression
  • Insomnia
  • Sexual dysfunction
  • Signs of worsening heart failure (e.g., swelling, weight gain, increased shortness of breath)
  • Symptoms of hypoglycemia (e.g., sweating, tremor, palpitations - note: these may be masked)

Special Patient Groups

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Pregnancy

Propranolol crosses the placenta. Use during pregnancy should only be considered if the potential benefit outweighs 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 for the first few days of life.

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 neonates post-delivery.
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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, hypoglycemia). Use with caution, especially in preterm or unstable infants. Consider alternative agents if possible.

Infant Risk: Low to moderate risk (L3).
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Pediatric Use

Safety and effectiveness of Inderal LA in pediatric patients have not been established. Immediate-release propranolol is used in pediatric populations for specific indications (e.g., infantile hemangioma, certain arrhythmias), 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 older adults.

Clinical Information

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Clinical Pearls

  • Always emphasize the importance of not abruptly discontinuing propranolol due to the risk of rebound effects, 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 bronchospasm in patients with asthma or COPD, and can mask symptoms of hypoglycemia in diabetics.
  • The LA formulation is designed for once-daily dosing, improving patient adherence compared to immediate-release formulations.
  • Patients should be advised to take their pulse regularly and report any significant slowing of heart rate.
  • Educate patients about orthostatic hypotension, especially when initiating therapy or increasing dose.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol - some are cardioselective)
  • Calcium channel blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Alpha-blockers (e.g., prazosin, doxazosin)
  • Central alpha-agonists (e.g., clonidine)
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Cost & Coverage

Average Cost: $30 - $100 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 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 check with your pharmacist for more information. If you have any questions or concerns about your 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.