Propranolol 1mg/ml Inj, 1ml

Manufacturer WEST-WARD Active Ingredient Propranolol Injection(proe PRAN oh lole) Pronunciation proe PRAN oh lole
It is used to treat certain types of abnormal heartbeats.
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Drug Class
Antihypertensive, Antiarrhythmic, Antianginal
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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
Nov 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a medication given by injection, often in a hospital setting, to help control your heart rate and blood pressure. It works by blocking certain natural chemicals in your body that affect the heart and blood vessels. This can help slow down a fast heart rate, lower high blood pressure, and reduce chest pain.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all provided guidelines. This drug is administered via intravenous injection.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Report any dizziness, lightheadedness, or slow heartbeat.
  • Report any difficulty breathing or wheezing.
  • If you are diabetic, be aware that this medication can hide the usual signs of low blood sugar, such as a fast heartbeat. Monitor your blood sugar closely.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
  • Do not stop this medication suddenly if you are on a long-term regimen, as it can worsen heart conditions. Your doctor will gradually reduce the dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Arrhythmias: 1-3 mg IV bolus over 10 minutes; may repeat after 2 minutes, then every 4 hours if needed. Max 10 mg for arrhythmias. Hypertensive emergencies: 1-3 mg IV over 10 minutes, may repeat after 2 minutes, then every 4-6 hours if needed.
Dose Range: 1 - 10 mg

Condition-Specific Dosing:

Arrhythmias: 1-3 mg IV bolus over 10 minutes; may repeat after 2 minutes, then every 4 hours if needed. Max 10 mg.
Hypertensive Emergencies: 1-3 mg IV over 10 minutes, may repeat after 2 minutes, then every 4-6 hours if needed.
Thyrotoxic Crisis: 1-3 mg IV over 10 minutes, may repeat after 2 minutes, then every 4-6 hours if needed. Max 10 mg/day.
Pheochromocytoma (pre-op): 1-3 mg IV over 10 minutes, may repeat after 2 minutes, then every 4-6 hours if needed. (Used with alpha-blockade)
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions (e.g., severe infantile hemangioma) may use oral, IV not standard.
Infant: Not established for routine use; specific conditions (e.g., severe infantile hemangioma) may use oral, IV not standard.
Child: Arrhythmias: 0.01-0.1 mg/kg IV over 10 minutes, max 1 mg/dose (up to 3 mg/day). Max single dose 1 mg for children < 1 year, 3 mg for children > 1 year.
Adolescent: Arrhythmias: 0.01-0.1 mg/kg IV over 10 minutes, max 1 mg/dose (up to 3 mg/day). Max single dose 1 mg for children < 1 year, 3 mg for children > 1 year. Adult dosing may apply for larger adolescents.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor closely for exaggerated response due to potential accumulation of active metabolites.
Dialysis: Propranolol is not significantly dialyzable. No specific supplemental dose needed, but monitor for effects.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocking agent. 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 reduces renin release from the kidneys. In the CNS, it can reduce sympathetic outflow. Its antiarrhythmic effects are due to reduction of SA nodal automaticity, AV nodal conduction velocity, and myocardial excitability.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV formulation (100% bioavailability)
Tmax: Not applicable for IV formulation (immediate effect)
FoodEffect: Not applicable for IV formulation

Distribution:

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

Elimination:

HalfLife: 3-6 hours (IV)
Clearance: Not available
ExcretionRoute: Renal (primarily metabolites)
Unchanged: <1% (IV)
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Pharmacodynamics

OnsetOfAction: Within minutes (IV)
PeakEffect: Within minutes (IV)
DurationOfAction: 4-6 hours (IV)

Safety & Warnings

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BLACK BOX WARNING

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 pectoris should be taken. 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 having occult atherosclerotic heart disease.
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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 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 rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ 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
Abnormal sensations, such as burning, numbness, or tingling
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

Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor if they bother you or do not go away:

Dizziness, drowsiness, fatigue, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Difficulty sleeping
Vivid or unusual dreams

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • Shortness of breath, wheezing, or difficulty breathing
  • Swelling in your ankles or feet, unusual weight gain (signs of heart failure)
  • Chest pain or discomfort that worsens
  • Coldness, numbness, or tingling in hands or feet
  • Unusual fatigue or weakness
  • Depression or mood changes
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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:
+ Heart block or sick-sinus syndrome (types of abnormal heartbeats)
+ Heart failure (weak heart)
+ Low blood pressure
+ Poor blood flow to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory conditions, including:
+ 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. Please inform your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems, including those not listed above

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any 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.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution 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 impact certain lab test results, so inform all your healthcare providers and lab personnel that you are taking this medication.

Interactions with Other Substances
Discuss alcohol consumption with your doctor before drinking. If you smoke, talk to your doctor about the potential risks. This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, particularly in individuals with diabetes, children, and those who are fasting or experiencing vomiting.

Special Considerations
If you have diabetes, closely monitor your blood sugar levels. Do not abruptly stop taking this medication, as this may lead to worsened chest pain or even heart attack, especially in individuals with certain types of heart disease. To avoid adverse effects, your doctor will guide you on how to gradually discontinue the medication. Seek immediate medical attention if you experience new or worsening chest pain or other heart problems.

Thyroid and Blood Pressure Considerations
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as rapid heartbeat. If you have hyperthyroidism and suddenly stop taking this medication, your condition may worsen and become life-threatening. Consult your doctor before using over-the-counter products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Allergic Reactions and Epinephrine
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.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Profound hypotension (very low blood pressure)
  • Cardiogenic shock
  • Bronchospasm (difficulty breathing, wheezing)
  • 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 IV fluids, atropine for bradycardia, glucagon, 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 (within 14 days) - risk of hypertensive crisis (theoretical, but caution advised)
  • Drugs that prolong QT interval (use with caution)
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Major Interactions

  • Other beta-blockers (additive effects)
  • Digoxin (additive bradycardia)
  • Clonidine (rebound hypertension upon clonidine withdrawal)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • Alpha-1 blockers (e.g., prazosin) - risk of profound hypotension
  • Amiodarone (additive bradycardia, AV block)
  • Fingolimod (severe bradycardia)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Sympathomimetics (e.g., epinephrine, norepinephrine, pseudoephedrine) - risk of hypertension, bradycardia
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased propranolol levels
  • CYP1A2 inhibitors (e.g., fluvoxamine) - increased propranolol levels
  • CYP2C19 inhibitors (e.g., omeprazole) - increased propranolol levels
  • Theophylline (reduced clearance of theophylline)
  • Lidocaine (reduced lidocaine clearance)
  • Warfarin (potential for increased anticoagulant effect)
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Minor Interactions

  • Alcohol (may increase propranolol levels)
  • Cimetidine (increased propranolol levels)
  • Hydralazine (increased propranolol levels)

Monitoring

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Baseline Monitoring

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia.

Timing: Prior to administration

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm, PR interval, and QTc, especially in patients with pre-existing cardiac conditions.

Timing: Prior to administration

Respiratory Status/Lung Sounds

Rationale: To assess for bronchospasm, especially in patients with asthma/COPD history.

Timing: Prior to administration

Blood Glucose (for diabetics)

Rationale: Propranolol can mask hypoglycemia symptoms.

Timing: Prior to administration

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Routine Monitoring

Heart Rate (HR)

Frequency: Continuously during IV administration, then regularly (e.g., every 15-30 min initially, then as clinically indicated)

Target: 50-90 bpm (individualized)

Action Threshold: <50 bpm or symptomatic bradycardia

Blood Pressure (BP)

Frequency: Continuously during IV administration, then regularly (e.g., every 15-30 min initially, then as clinically indicated)

Target: Individualized based on indication

Action Threshold: Significant hypotension (e.g., SBP <90 mmHg or symptomatic hypotension)

Electrocardiogram (ECG)

Frequency: Continuous monitoring during IV administration, especially with initial doses or dose adjustments.

Target: Normal sinus rhythm, PR interval <0.20 sec

Action Threshold: New arrhythmias, significant PR prolongation, AV block

Respiratory Status/Oxygen Saturation

Frequency: Regularly (e.g., every 1-4 hours or as needed)

Target: >92%

Action Threshold: Wheezing, dyspnea, SpO2 <90%

Blood Glucose (for diabetics)

Frequency: Regularly, especially if diabetic or at risk for hypoglycemia.

Target: 70-180 mg/dL

Action Threshold: <70 mg/dL

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Symptom Monitoring

  • Bradycardia (dizziness, lightheadedness, syncope)
  • Hypotension (dizziness, lightheadedness, fatigue)
  • Bronchospasm (wheezing, shortness of breath, cough)
  • Heart failure exacerbation (dyspnea, edema, weight gain)
  • Fatigue, weakness
  • Cold extremities
  • Depression, sleep disturbances
  • Masked hypoglycemia symptoms (sweating, hunger, confusion)

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 propranolol in utero may be at risk for bradycardia, hypoglycemia, and respiratory depression. Monitor neonates for these effects for several days after birth.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed.
Second Trimester: Potential for fetal growth restriction, bradycardia, hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and intrauterine growth restriction. Monitor neonates closely 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). Generally considered compatible with breastfeeding with caution.

Infant Risk: Low to moderate risk (L3). Monitor for bradycardia, hypotension, hypoglycemia, and respiratory depression.
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Pediatric Use

Use in pediatric patients, especially neonates and infants, requires careful dose titration and close monitoring due to potential for exaggerated response, bradycardia, and hypoglycemia. Dosing is weight-based. IV use is typically reserved for acute, severe conditions like arrhythmias or thyrotoxic crisis.

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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. Increased risk of adverse effects due to age-related decline in renal and hepatic function, and polypharmacy. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always administer IV propranolol slowly (over 10 minutes) to minimize the risk of severe bradycardia or hypotension.
  • Have atropine and glucagon readily available for management of severe bradycardia or hypotension.
  • Contraindicated in patients with bronchial asthma, severe COPD, sinus bradycardia, AV block (second or third degree), cardiogenic shock, or decompensated heart failure.
  • Use with extreme caution in patients with diabetes due to masking of hypoglycemia symptoms and potential for prolonged hypoglycemia.
  • In patients with pheochromocytoma, propranolol should only be initiated after adequate alpha-adrenergic blockade has been established to prevent unopposed alpha-stimulation and hypertensive crisis.
  • Monitor for signs of heart failure exacerbation, especially in patients with pre-existing cardiac dysfunction.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, esmolol, labetalol - depending on indication and selectivity)
  • Calcium channel blockers (e.g., verapamil, diltiazem for arrhythmias; amlodipine, nifedipine for hypertension)
  • ACE inhibitors/ARBs (for hypertension)
  • Diuretics (for hypertension, heart failure)
  • Antiarrhythmics (e.g., adenosine, amiodarone, digoxin for specific arrhythmias)
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Cost & Coverage

Average Cost: Not available per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate timely and appropriate care.