Propranolol


Generic Medicine Info
Indications and Dosage
Intravenous
Emergency treatment of cardiac arrhythmias, Thyrotoxic crisis
Adult: 1 mg via IV inj over 1 minute, may be repeated every 2 minutes until response is achieved. Max: 10 mg in conscious patients or 5 mg in patients under anaesthesia. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Cardiac arrhythmias
Adult: As conventional tab or oral solution: 10-40 mg 3-4 times daily.
Child: As conventional oral solution or tab: 0.25-0.5 mg/kg 3-4 times daily.

Oral
Angina pectoris
Adult: As conventional tab or oral solution: Initially, 40 mg 2-3 times daily, may be increased at weekly intervals according to response. Usual range: 120-240 mg daily. As extended-release cap: 80 mg once daily, may be increased to 160 mg once daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Hypertrophic cardiomyopathy
Adult: As conventional tab or oral solution: 10-40 mg 3-4 times daily.

Oral
Essential tremor
Adult: As conventional tab or oral solution: Initially, 40 mg 2-3 times daily, may be increased according to response. Usual range: 120-320 mg daily. As extended-release cap: 80 mg once daily. Dose may be increased to 160 mg daily and, if needed, further increased to 240 mg daily.

Oral
Proliferating infantile haemangioma
Child: ≥5 weeks Hemangeol (4.28 mg/mL oral solution) Patients weighing ≥2 kg: Start treatment between 5 weeks and 5 months of age. Initially, 0.6 mg/kg (0.15 mL/kg) bid for 7 days, then increase to 1.1 mg/kg (0.3 mL/kg) bid for additional 7 days and then increase to maintenance dose of 1.7 mg/kg (0.4 mL/kg) bid for 6 months. Doses are given at least 9 hours apart during or right after feeding or meals. Adjust dose periodically as the child's weight increases. Treatment may be restarted if haemangiomas recur. Treatment recommendations and product availability may vary between countries (refer to specific product guidelines).

Oral
Tetralogy of Fallot
Child: Infants and children As conventional oral solution: For treatment and prophylaxis of cyanotic attacks and for relief of right-ventricular outflow tract obstruction: Up to 1 mg/kg 3-4 times daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Anxiety
Adult: As conventional tab or oral solution: For short-term relief of acute situational anxiety: 40 mg daily. For relief of generalised anxiety symptoms: 40 mg bid, may be increased if necessary to 40 mg tid. Dosage or treatment recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Phaeochromocytoma
Adult: As conventional tab or oral solution: As adjunctive treatment to α-receptor blocker: 60 mg daily for 3 days before the surgery. As adjunctive treatment to α-receptor blocker for inoperable cases: 30 mg daily.
Child: As conventional oral solution or tab: 0.25-0.5 mg/kg 3-4 times daily.

Oral
Thyrotoxicosis
Adult: As adjunctive treatment: As conventional tab or oral solution: 10-40 mg 3-4 times daily. As extended-release cap: 80 mg once daily. Dose may be increased to 160 mg daily.
Child: As conventional oral solution or tab: 0.25-0.5 mg/kg 3-4 times daily. Adjust dose according to response.

Oral
Prophylaxis of variceal bleeding in portal hypertension
Adult: As conventional tab or oral solution: Initially, 40 mg bid, may be increased to 80 mg bid depending on heart rate response. Max: 160 mg bid.

Oral
Hypertension
Adult: Monotherapy or in combination with other antihypertensive agents (e.g. thiazide diuretics): As conventional tab or oral solution: Initially, 40-80 mg bid, may be increased at weekly intervals according to response. Usual range: 160-320 mg daily. Max: 640 mg daily. As extended-release cap: Initially, 80 mg once daily, or 160 mg once daily. Dose may be increased if necessary until adequate response is achieved. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Post-myocardial infarction
Adult: For long-term prophylaxis after recovery from acute MI: As conventional tab or oral solution: Initiate treatment within 5-21 days of MI. Initially, 40 mg 4 times daily for 2-3 days, followed by 80 mg bid. Alternatively, 180-240 mg daily in divided doses. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Prophylaxis of migraine
Adult: As conventional tab or oral solution: Initially, 40 mg 2-3 times daily, may be increased at weekly intervals according to response. Usual range: 80-160 mg daily. Max: 240 mg daily. As extended-release cap: Initially, 80 mg once daily, may be increased gradually to achieve optimum migraine prophylaxis. Usual range: 160-240 mg once daily.
Child: As conventional oral solution or tab: ≤12 years 10-20 mg 2-3 times daily; >12 years Same as adult dose.

Administration
tab: Should be taken on an empty stomach.
cap: May be taken with or without food. Take consistently either always w/ or always w/o meals.
Contraindications
Current or history of bronchial asthma or bronchospasm; bradycardia, cardiogenic shock, hypotension, metabolic acidosis, after prolonged fasting, severe peripheral arterial circulatory disturbances, 2nd- or 3rd-degree heart block, sick sinus syndrome, Prinzmetal's angina, uncontrolled heart failure, phaeochromocytoma that has not been treated with α-receptor blocker. Additional contraindications for Hemangeol: Heart rate <80 bpm, blood pressure <50/30 mmHg; premature infants with corrected age <5 weeks and infants weighing <2 kg.
Special Precautions
Patient with 1st-degree heart block, compensated heart failure, diabetes mellitus, myasthenia gravis, history of anaphylactic reaction to allergens, less severe peripheral circulatory disturbances, Wolff-Parkinson-White Syndrome. Patient undergoing surgery. Avoid abrupt withdrawal (particularly in patients with ischaemic heart disease); chronic therapy must not be routinely withdrawn before major surgery. May mask the signs and symptoms of hypoglycaemia and hyperthyroidism (particularly tachycardia). Renal and hepatic impairment. Neonates, children, and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Bradycardia (including heart block, sinus pause, and cardiac arrest), cardiac failure, bronchospasm, hypoglycaemia; exacerbation of angina and acute MI following abrupt withdrawal.
Blood and lymphatic system disorders: Rarely, thrombocytopenia.
Eye disorders: Rarely, visual disturbances, dry eye.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation.
General disorders and administration site conditions: Fatigue.
Immune system disorders: Hypersensitivity reactions (including anaphylactic reactions).
Investigations: Increased serum K, serum transaminases, alkaline phosphatase.
Nervous system disorders: Rarely, dizziness.
Psychiatric disorders: Sleep disturbances, nightmares. Rarely, hallucinations, psychoses, confusion, mood changes.
Skin and subcutaneous tissue disorders: Rarely, alopecia, purpura, psoriasiform skin reaction, rash.
Vascular disorders: Cold extremities, Raynaud's phenomenon.
IV/Parenteral/PO: C
Monitoring Parameters
Monitor blood pressure, heart rate, ECG; serum glucose (in patients with diabetes mellitus). For infantile haemangioma: Monitor blood pressure and heart rate for 2 hours following initiation or increase in dose.
Overdosage
Symptoms: Hypotension, bradycardia, pulmonary oedema, syncope, cardiogenic shock, QRS complex prolongation, ventricular tachycardia, 1st- to 3rd-degree heart block, ventricular fibrillation or asystole, drowsiness, confusion, seizures, hallucinations, dilated pupils, bronchospasm, hyperkalaemia, coma, and occasionally CNS-mediated respiratory depression. Management: Symptomatic and supportive treatment. Discontinue treatment in cases of overdose or extreme falls in heart rate or blood pressure. Clear the airway and monitor vital signs until stable. For recent ingestion, use gastric lavage, activated charcoal, and laxative to prevent absorption of any drug still present in the gastrointestinal tract. Administer plasma or plasma substitutes to treat hypotension and shock. Excessive bradycardia may be countered with 1-2 mg IV atropine and/or a cardiac pacemaker. This may be followed by an IV bolus dose of 10 mg glucagon if necessary, which may be repeated or followed by an IV infusion of glucagon (1-10 mg/hour) depending on the response. If the patient does not respond to glucagon or if glucagon is unavailable, a β-adrenoceptor stimulant (e.g. dobutamine 2.5-10 mcg/kg/min IV infusion) may be given. Bronchospasm may be treated by β2-receptor agonist bronchodilators (e.g. salbutamol); oxygen or artificial ventilation may be required in severe cases.
Drug Interactions
May have additive negative inotropic effect with anti-arrhythmic agents (e.g. disopyramide, amiodarone, quinidine) and Ca channel blockers with negative inotropic effect (e.g. verapamil, diltiazem). May increase AV conduction time with digitalis glycoside. Increased plasma concentration with CYP2D6 and CYP1A2 inhibitors (e.g. cimetidine). May cause vasospastic reactions with ergotamine, dihydroergotamine or related compounds. May decrease hypotensive effect with NSAIDs (e.g. ibuprofen, indometacin). Increased risk of hypotension and attenuation of the reflex tachycardia with anaesthetic drugs. May enhance the hypoglycaemic effect of insulin. May exacerbate the rebound hypertension following the withdrawal of clonidine. May enhance the hypotensive effect of prazosin, reserpine, MAOIs, and TCAs. Concurrent use with sympathomimetic agents (e.g. epinephrine) may counteract the effects of propranolol. Concomitant use of propranolol and chlorpromazine may result in increased plasma concentrations and enhanced effects of both drugs. May increase the plasma concentration of lidocaine, rizatriptan, and warfarin.
Food Interaction
Alcohol may increase or decrease plasma levels of propranolol. Protein-rich foods may increase the bioavailability of propranolol.
Lab Interference
May interfere with glaucoma screening, estimation of serum bilirubin by diazo method, and determination of catecholamines using fluorescence.
Action
Description:
Mechanism of Action: Propranolol, a nonselective β-adrenergic blocker, is a competitive antagonist at both β1- and β2-receptors resulting in decreased heart rate, myocardial contractility, blood pressure, and myocardial oxygen demand. It has negative inotropic effects and membrane-stabilising activities but does not possess intrinsic sympathomimetic activity.
Onset: β-blockade: 1-2 hours (oral); ≤5 minutes (IV).
Duration: 6-12 hours (immediate-release); approx 24-27 hours (extended-release).
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability: Approx 25%; increased by approx 50% with protein-rich foods. Time to peak plasma concentration: Approx 1-4 hours (immediate-release); 12-14 hours (extended-release).
Distribution: Rapidly and widely distributed throughout the body with the highest concentrations in the brain, lungs, kidney, liver, and heart. Crosses the placenta and blood-brain barrier; enters breast milk. Volume of distribution: 4 L/kg. Plasma protein binding: Approx 80-95%.
Metabolism: Undergoes extensive first-pass effect. Metabolised in the liver into active and inactive metabolites, metabolic pathways include aromatic hydroxylation by CYP2D6, N-dealkylation followed by further side-chain oxidation mainly by CYP1A2, and to some extent by CYP2D6, and direct glucuronidation; primary metabolites include propranolol glucuronide, naphthyloxylactic acid, and glucuronic acid and sulfate conjugates of 4-hydroxypropranolol (active).
Excretion: Mainly via urine (96-99%, <1% as unchanged drug). Elimination half-life: Approx 3-6 hours (immediate-release); 8-10 hours (extended-release).
Chemical Structure

Chemical Structure Image
Propranolol

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4946, Propranolol. https://pubchem.ncbi.nlm.nih.gov/compound/Propranolol. Accessed Aug. 24, 2023.

Storage
Tab/Cap: Store between 15-30°C. Protect from light, moisture, or excessive heat. Oral solution/IV inj: Store between 20-25°C. Protect from light or excessive heat. Do not refrigerate or freeze the oral solution. Storage recommendations may vary between products (refer to specific product guidelines).
MIMS Class
Antimigraine Preparations / Beta-Blockers
ATC Classification
C07AA05 - propranolol ; Belongs to the class of non-selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
References
Angilol 10 mg Film-coated Tablets (Chelonia Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/06/2023.

Anon. Propranolol (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/06/2023.

Anon. Propranolol. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/06/2023.

Anon. Propranolol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/06/2023.

Bedranol 80 mg SR Capsules (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/06/2023.

Buckingham R (ed). Propranolol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/06/2023.

Hemangeol Solution (Pierre Fabre Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/06/2023.

Inderal 10 mg and 40 mg Tablet (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/06/2023.

Inderal LA Capsule, Extended Release (ANI Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/06/2023.

Inderal XL Capsule, Extended Release (ANI Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/06/2023.

Joint Formulary Committee. Propranolol Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/06/2023.

Paediatric Formulary Committee. Propranolol Hydrochloride. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 08/06/2023.

Properol 1 mg/mL Injection (Zulat Pharmacy Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/06/2023.

Propranolol Hydrochloride Injection, Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/08/2023.

Propranolol Hydrochloride Solution (West Ward Pharmaceuticals Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/08/2023.

Propranolol Hydrochloride Tablet (Amici Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/08/2023.

Propranolol Rosemont 5 mg/5 mL Oral Solution (Rosemont Pharmaceuticals Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 08/06/2023.

Propranolol. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 08/06/2023.

Teva Pharma (New Zealand) Limited. Drofate 10 mg and 40 mg Tablets data sheet 4 June 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 08/06/2023.

Viatris Ltd. Cardinol LA 160 mg Modified Release Capsule data sheet 18 July 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 08/06/2023.

Disclaimer: This information is independently developed by MIMS based on Propranolol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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