Propranolol 40mg/5ml Solution

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks beta-1 and beta-2 adrenergic receptors, leading to decreased heart rate, myocardial contractility, and cardiac output. It also reduces renin release from the kidneys and inhibits sympathetic outflow from the central nervous system. Its anti-migraine effect is thought to involve blockade of beta-receptors in cerebral vasculature and modulation of serotonin pathways.

Serious Side Effects: Seek Medical Help 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 attention 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
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

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 attention 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.

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 and its symptoms.
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 the 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 health problems and medications with your doctor.

To ensure safe treatment, 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
Your complete medical history

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

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 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 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, consult with your doctor, as 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 undergoing surgery.

Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.

Stopping the Medication
Do not 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 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, contact your doctor immediately.

Thyroid Conditions
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. Consult with your doctor.

Interactions with Over-the-Counter Products
If you have high blood pressure, consult with 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
If you have a history of severe allergic reactions, discuss with your doctor, as you may be at risk of a more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult with your doctor, as epinephrine may be less effective while taking this medication. Ensure you have the correct epinephrine strength, as multiple strengths are available.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of this medication to you and your baby.

• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, heart block, and hypotension.
• MAO inhibitors (MAOIs) - risk of hypertensive crisis if MAOI is stopped and propranolol is started, or vice versa.

• Other beta-blockers (additive effects)
• Antiarrhythmics (e.g., amiodarone, digoxin) - increased risk of bradycardia, heart block.
• Clonidine - risk of rebound hypertension if clonidine is withdrawn abruptly while on propranolol.
• Insulin and oral hypoglycemics - can mask symptoms of hypoglycemia (tachycardia, tremors) and prolong hypoglycemic episodes.
• NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect of propranolol.
• Alpha-1 blockers (e.g., prazosin, doxazosin) - increased risk of orthostatic hypotension.
• Cimetidine - increases propranolol plasma concentrations.
• Rifampin, Phenobarbital, Phenytoin - decrease propranolol plasma concentrations.
• Alcohol - increases propranolol plasma concentrations.
• Fingolimod - increased risk of bradycardia.

• Lidocaine - propranolol can reduce lidocaine clearance, increasing toxicity risk.
• Theophylline - propranolol can reduce theophylline clearance.
• Warfarin - propranolol may enhance anticoagulant effect.
• Epinephrine - paradoxical hypertension and bradycardia.
• SSRIs (e.g., fluoxetine, paroxetine) - may increase propranolol levels.
• Tobacco smoking - may decrease propranolol levels.

• Antacids (aluminum/magnesium hydroxide) - may decrease propranolol absorption (separate administration).

• Dizziness
• Lightheadedness
• Fatigue
• Bradycardia (slow heart rate)
• Dyspnea (shortness of breath)
• Wheezing
• Cold extremities
• Depression
• Insomnia
• Sexual dysfunction
• Signs of heart failure (e.g., swelling, weight gain)

Category D. Propranolol crosses the placenta. Use during pregnancy, especially prolonged use in the second and third trimesters, has been associated with fetal growth restriction, bradycardia, hypoglycemia, and respiratory depression in the neonate. Use only if the potential benefit justifies the potential risk to the fetus.

L3 (Moderately Safe). Propranolol is excreted into breast milk in small amounts. While adverse effects in breastfed infants are generally rare, monitor the infant for signs of beta-blockade such as bradycardia, hypotension, and hypoglycemia, especially in premature or jaundiced infants, or those with impaired renal function. Consider using the lowest effective dose and monitoring the infant.

Dosing is weight-based and varies significantly by indication (e.g., hypertension, arrhythmias, infantile hemangioma). Close monitoring for adverse effects (especially bradycardia, hypotension, hypoglycemia) is crucial. Specific formulations (e.g., Hemangeol for infantile hemangioma) are available and preferred for certain pediatric uses.

Start with lower doses and titrate slowly due to increased sensitivity to beta-blockers and potential for reduced hepatic metabolism and renal clearance. Increased risk of adverse effects such as bradycardia, hypotension, and CNS effects (e.g., fatigue, depression). Monitor closely for signs of heart failure or bronchospasm.

• Propranolol is highly lipophilic, allowing it to cross the blood-brain barrier, which contributes to its efficacy in conditions like migraine prophylaxis, essential tremor, and performance anxiety.
• It is a non-selective beta-blocker, meaning it blocks both beta-1 (cardiac) and beta-2 (pulmonary, vascular, metabolic) receptors. This makes it contraindicated or used with extreme caution in patients with asthma, COPD, or severe peripheral artery disease due to the risk of bronchospasm and vasoconstriction.
• Can mask the signs of hypoglycemia (tachycardia, tremors) in diabetic patients, making it important for these patients to monitor blood glucose closely.
• Abrupt discontinuation can lead to rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with underlying coronary artery disease. Tapering is essential.
• Food increases the bioavailability of propranolol, so consistent administration with food is recommended to maintain stable drug levels.

• 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)
• Alpha-blockers (e.g., prazosin, doxazosin)
• Central alpha-agonists (e.g., clonidine)
• For migraine prophylaxis: Topiramate, Valproic acid, CGRP inhibitors (e.g., erenumab, fremanezumab)
• For essential tremor: Primidone

If your symptoms or health issues persist or worsen, it is 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.