Propranolol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Hypertension 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/day. As extended-release cap: 80 mg once daily. Angina pectoris As conventional tab or oral solution: Initially, 40 mg bid-tid, may be increased according to response. Usual range: 120-240 mg daily. As extended-release cap: 80mg once daily, may be increased to 160 mg once daily. Max: 320 mg. Prophylaxis of migraine As conventional tab or oral solution: Initially, 40 mg bid-tid, may be increased according to response. Usual range: 80-160 mg daily. As extended-release cap: Initially, 80mg once daily, may be increased according to response. Usual effective dose: 160-240 mg once daily. Essential tremor As conventional tab or oral solution: Initially, 40 mg bid-tid, may be increased according to response. Usual range: 80-160 mg daily. As extended-release cap: Initially, 80mg once daily, may be increased according to response. Usual effective dose: 160-240 mg once daily. Cardiac arrhythmias As conventional tab or oral solution: 10-40 mg 3-4 times daily. Myocardial infarction As conventional tab or oral solution: Initiate within 5-21 days of MI, 40 mg 4 times daily for 2-3 days, followed by 80 mg bid. Phaeochromocytoma As conventional tab or oral solution: In combination with an α-blocker: 60 mg daily for 3 days before the surgery. If tumour is unsuitable for surgery, 30 mg/day in divided doses. Hypertrophic cardiomyopathy As conventional tab or oral solution:10-40 mg 3-4 times daily. As extended-release cap: 80-160 mg once daily. Hyperthyroidism As conventional tab or oral solution: 10-40 mg 3-4 times daily. As extended release cap: 80 mg once daily, may be increased to 160 mg daily. Max: 240 mg/day. Anxiety As conventional tab or oral solution: 40 mg daily, may be increased if necessary to 40 mg bid-tid. As extended release cap: 80 mg once daily. Portal hypertension As conventional tab or oral solution: Initially, 40 mg bid, may be increased to 80 mg bid depending on heart rate response. As extended release cap: 80 mg once daily, may be increased to 160 mg once daily. Max: 320 mg once daily. IV Emergency treatment of cardiac arrhythmias 1 mg given over 1 minute, may be repeated if necessary every 2 minutes. Max: 10 mg in conscious patients and 5 mg in patients under anaesthesia.
Dosage Details
Intravenous
Emergency treatment of cardiac arrhythmias
Adult: 1 mg given over 1 minute, may be repeated if necessary every 2 minutes. Max: 10 mg in conscious patients and 5 mg in patients under anaesthesia.

Oral
Phaeochromocytoma
Adult: As conventional tab or oral solution: In combination with an α-blocker: 60 mg daily for 3 days before the surgery. If tumour is unsuitable for surgery, 30 mg/day in divided doses.
Child: As conventional tab or oral solution: 0.25-0.5 mg/kg 3-4 times daily.

Oral
Hypertension
Adult: 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/day. As extended-release cap: 80 mg once daily.

Oral
Myocardial infarction
Adult: As conventional tab or oral solution: Initiate within 5-21 days of MI, 40 mg 4 times daily for 2-3 days, followed by 80 mg bid.

Oral
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. As extended release cap: 80 mg once daily, may be increased to 160 mg once daily. Max: 320 mg once daily.

Oral
Prophylaxis of migraine
Adult: As conventional tab or oral solution: Initially, 40 mg bid-tid, may be increased according to response. Usual range: 80-160 mg daily. As extended-release cap: Initially, 80mg once daily, may be increased according to response. Usual effective dose: 160-240 mg once daily.
Child: As conventional tab or oral solution: ≤12 years 10-20 mg bid or tid; >12 years Initially, 40 mg bid or tid, may be increased according to response.

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

Oral
Essential tremor
Adult: As conventional tab or oral solution: Initially, 40 mg bid-tid, may be increased according to response. Usual range: 80-160 mg daily. As extended-release cap: Initially, 80mg once daily, may be increased according to response. Usual effective dose: 160-240 mg once daily.

Oral
Anxiety
Adult: As conventional tab or oral solution: 40 mg daily, may be increased if necessary to 40 mg bid-tid. As extended release cap: 80 mg once daily.

Oral
Angina pectoris
Adult: As conventional tab or oral solution: Initially, 40 mg bid-tid, may be increased according to response. Usual range: 120-240 mg daily. As extended-release cap: 80mg once daily, may be increased to 160 mg once daily. Max: 320 mg.

Oral
Hypertrophic cardiomyopathy
Adult: As conventional tab or oral solution:10-40 mg 3-4 times daily. As extended-release cap: 80-160 mg once daily.

Oral
Hyperthyroidism
Adult: As conventional tab or oral solution: 10-40 mg 3-4 times daily. As extended release cap: 80 mg once daily, may be increased to 160 mg daily. Max: 240 mg/day.
Child: As conventional tab or oral solution: 0.25-0.5 mg/kg 3-4 times daily.
Hepatic Impairment
Reduce 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
History of bronchial asthma, bronchospasm chronic obstructive airways disease, bradycardia, cardiogenic shock, hypotension, metabolic acidosis, severe peripheral arterial circulatory disturbances, 2nd or 3rd degree heart block, sick sinus syndrome, untreated pheochromocytoma, uncontrolled heart failure, Prinzmetal’s angina.
Special Precautions
Patient with Raynaud’s disease or intermittent claudication, 1st degree heart block, diabetes mellitus, myasthenia gravis, psoriasis, thyroid disease. Avoid abrupt. Hepatic and renal impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Blood and lymphatic system disorders: Agranulocytosis, thrombocytopenia.
Cardiac disorders: Bradycardia, cardiac failure, AV block.
Eye disorders: Visual disturbances, dry eye, conjunctivitis.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dry mouth.
General disorders and administration site conditions: Lethargy, fatigue.
Immune system disorders: Hypersensitivity, anaphylactic reactions.
Nervous system disorders: Dizziness.
Psychiatric disorders: Hallucination, psychoses, depression, mood changes, confusion, memory loss, sleep disturbances, nightmares.
Reproductive system and breast disorders: Impotence, erectile dysfunction.
Respiratory, thoracic and mediastinal disorders: Bronchospasm.
Skin and subcutaneous tissue disorders: Alopecia, psoriasiform reaction, skin rash.
Vascular disorders: Hypotension, cold extremities, Raynaud’s phenomenon.
IV/Parenteral/PO: C
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood pressure, heart rate, ECG, and serum glucose (in patients with diabetes mellitus).
Overdosage
Symptoms: Hypotension, bradycardia, pulmonary oedema, syncope, cardiogenic shock, drowsiness, confusion, seizures, hallucinations, dilated pupils, bronchospasm, vomiting, and occasionally CNS-mediated respiratory depression. Management: Symptomatic and supportive treatment. For ingestion within 1 hour of more than the therapeutic dose, consider activated charcoal (50 g for adults, 1 g/kg for children) or gastric lavage (in adults for potentially life-threatening overdose). Administer atropine (3 mg IV for adult and 0.04 mg/kg for child) for bradycardia. Excessive bradycardia may be countered with atropine to 1-2 mg IV and/or require a cardiac pacemaker. If necessary, this may be followed with an IV bolus of glucagon 10 mg or glucagon 1-10 mg/hour IV infusion. If the patient does not respond to glucagon or if glucagon is unavailable, dobutamine 2.5-10 mcg/kg/minute IV infusion may be given. For severe hypotension, heart failure, or cardiogenic shock, administer glucagon (5-10 mg IV bolus for adults and 50-150 mcg/kg for child) over 10 minutes to reduce tendencies of vomiting, followed by 1-5 mg/hour infusion, titrated according to response. If glucagon is not available or the patient does not respond to glucagon, isoprenaline 5-10 mcg/minute for adults and 0.02 mcg/kg/minute in children may be given, increased according to response. In severe hypertension, administer dobutamine 2.5-40 mcg/min/minute (adults and children). For bronchospasm, nebulise 2.5-5 mg of salbutamol. In severe cases, give aminophylline 5 mg/kg IV over 30 minutes followed by an infusion of 0.5-1 mg/kg/hour. Do not give loading dose of 5 mg/kg if patient is taking oral theophylline or aminophylline. In cases of generalised spasm, diazepam 0.1-0.3 mg/kg IV may be used.
Drug Interactions
May have potentiating effects on arterial conduction time and induce additive negative or inotropic effect with propafenone, amiodarone, quinidine, flecainide and Ca channel blockers. Concomitant administration with catecholamine-depleting drugs (e.g. reserpine), MAOIs or TCAs may cause additive effects and potentiate hypotension. Reduced antihypertensive effect with NSAIDs (e.g. ibuprofen, indometacin). May enhance vasoconstrictive action of ergot alkaloids. Coadministration with warfarin increases its bioavailability and prothrombin time. May enhance hypoglycaemic effects of insulin. Increased risk of hypotension and attenuation of the reflex tachycardia with anaesthetic drugs. Increased plasma concentration with lidocaine.
Food Interaction
Alcohol may increase or decrease plasma levels of propranolol. Protein rich foods may increase bioavailability.
Lab Interference
May interfere with glaucoma screening, estimation of serum bilirubin by the diazo method, and determination of catecholamines by using fluorescence.
Action
Description: Propranolol is a nonselective ß-adrenergic blocker that competitively blocks ß1 and ß2-receptors resulting in decreased heart rate, myocardial contractility, BP and myocardial oxygen demand. It has negative inotropic effects and membrane-stabilising activities but does not possess intrinsic sympathomimetic activities.
Onset: 1-2 hours (oral).
Duration: Approx 6-12 hours (immediate-release); approx. 24-27 hours (extended-release).
Pharmacokinetics:
Absorption: Almost completely absorbed from the gastrointestinal tract. Bioavailability: Approx 25%. Time to peak plasma concentration: Approx 1-2 hours.
Distribution: Widely distributed, crosses the blood brain barrier and placenta, enters the breast milk. Volume of distribution: 4 L/kg. Plasma protein binding: Approx 90%.
Metabolism: Undergoes hepatic metabolism via CYP2D6 isoenzyme, and CYP1A2 to 4-hydroxypropranolol (biologically active).
Excretion: Mainly via urine (96-99%, <1% as unchanged drug). Elimination half-life: Approx 3-6 hours.
Chemical Structure

Chemical Structure Image
Propranolol

Source: National Center for Biotechnology Information. PubChem Database. Propranolol, CID=4946, https://pubchem.ncbi.nlm.nih.gov/compound/Propranolol (accessed on Jan. 23, 2020)

Storage
Store between 20-25°C. Protect from light and moisture.
ATC Classification
C07AA05 - propranolol ; Belongs to the class of non-selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
References
Anon. Propranolol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/03/2019.

Buckingham R (ed). Propranolol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/03/2019.

Joint Formulary Committee. Propranolol Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/03/2019.

Propranolol Hydrochloride Capsule, Extended Release (Breckenridge Pharmaceutical, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/03/2019.

Propranolol Hydrochloride Capsule, Extended Release (Nortec Development Associates, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/03/2019.

Propranolol Hydrochloride Injection, Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 27/03/2019.

Propranolol Hydrochloride Solution (West Ward Pharmaceuticals Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/03/2019.

Propranolol Hydrochloride Tablet (Impax Generics). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/03/2019.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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