Propranolol

Registered South African indications:

• Reduce cardiovascular mortality in those who have survived the acute phase of myocardial infarction and are clinically stable
• Angina pectoris
• Essential and renal hypertension
• Essential and senile tremor and the management of Parkinsonian tremor
• Anxiety-related autonomic symptoms
• Anxiety tachycardia
• Cardiac dysrhythmias, especially supra-ventricular tachydysrhythmias, dysrhythmias triggered by sympathetic overstimulation
• Adjunct in the management of hyperthyroidism and thyrotoxic crisis
• Hypertrophic obstructive cardiomyopathy
• Phaeochromocytoma (in the presence of effective alpha blockage)
• Prophylaxis of migraine

Contraindications

South African recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Bradycardia
• Cardiogenic shock
• Hypotension
• Metabolic acidosis
• Prolonged fasting
• Severe peripheral arterial circulatory disturbances
• Second or third degree heart block
• Sick sinus syndrome
• Phaeochromocytoma uncontrolled by α-blockade
• Uncontrolled heart failure
• Prinzmetal's angina
• Patients prone to hypoglycaemia, i.e. patients after prolonged fasting or patients with restricted counter-regulatory reserves
• Pregnancy
• Lactation
• Bronchospasm or asthma
• History of obstructive airways disease
• Particular caution should be taken in the perioperative period, it is generally unwise to reduce the dosage of propranolol to which the patient is accustomed

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or to any of the excipients
• History of bronchial asthma or bronchospasm
• Bradycardia
• Cardiogenic shock
• Hypotension
• Metabolic acidosis
• After prolonged fasting
• Severe peripheral arterial circulatory disturbances
• Second or third degree heart block
• Sick sinus syndrome
• Untreated phaeochromocytoma
• Uncontrolled heart failure
• Prinzmetal's angina
• Patients prone to hypoglycaemia, i.e., patients after prolonged fasting or patients with restricted counter-regulatory reserves

Cautions 

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Hepatic impairment
• Elderly
• Heart failure
• First degree heart block
• Sudden discontinuation of treatment in ischaemic heart disease
• Portal hypertension  
• Raynaud's disease
• Intermittent claudication
• Masking of thyrotoxicosis and hyperthryoidism
• History of anaphylaxis
• Myasthenia gravis
• Psoriasis
• Abrupt withdrawl of treatment
• Decompensated cirrhosis
• Hepatic encephalopathy
• Diabetes mellitus
• Hypersensitivity to carmoisine (E122) in some formulations
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: fct, tab

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Reduce cardiovascular mortality in those who have survived the acute phase of myocardial infarction and are clinically stable

• Oral (fct, tab): 180-240mg/day, in 3 divided doses; Start between days 5-21 post-myocardial infarction

The effectiveness and safety of daily dosages greater than 240mg for prevention of cardiac mortality have not been established. However, higher dosages may be needed to effectively treat co-existing diseases such as angina or hypertension

Angina pectoris
Essential and renal hypertension

• Oral (fct, tab): Initial: 40mg, 2-3 times daily, before meals; Increase by 40mg at weekly intervals based on patient response; Adequate response is usually seen with 120-320mg/day

Hypertension: Further reduction in blood pressure can be obtained when used in conjunction with diuretics and/or other antihypertensive therapy

Essential and senile tremor, and the management of Parkinsonian tremor
Anxiety-related autonomic symptoms

• Oral (fct, tab): Initial: 40mg, 2-3 times daily, before meals; Increase by 40mg at weekly intervals based on patient response; Adequate response is usually seen with 80-160mg/day

Cardiac dysrhythmias, especially supra-ventricular tachydysrhythmias, dysrhythmias triggered by sympathetic overstimulation
Anxiety tachycardia
Adjunct in the management of hyperthyroidism and thyrotoxic crisis
Management of hypertrophic obstructive cardiomyopathy
Prophylaxis of migraine

• Oral (fct, tab): 10-40mg, 3-4 times daily, most patients respond within this dosage range

Management of pheochromocytoma (Additional agent is required)
- In combination with an alpha-receptor blocking medicine

• Oral (fct, tab): Pre-operatively: 60mg, daily for 3 days; Non-operable malignant cases: 30mg, daily

Propranolol tablets should preferably be taken before food

No information available for children in South Africa

Pregnancy

South African recommendations

• Contraindicated
• Propranolol should not be used during pregnancy
• Beta-blockers such as propranolol reduce placental perfusion, which can result in intra-uterine foetal death, immature or premature deliveries
• Adverse effects, such as hypoglycaemia and bradycardia in the newborn, and bradycardia in the foetus, may occur when propranolol is used during pregnancy
• There is an increased risk of cardiac and pulmonary complications in the newborn in the post-natal period when propranolol is used during pregnancy

Recommendations in other jurisdictions

• Caution
• Propranolol should not be given during pregnancy unless its use is essential
• No evidence of teratogenicity with propranolol has been reported
• However, beta-blockers like propranolol reduce placental perfusion, which may result in intra-uterine foetal death, immature, and premature deliveries
• Adverse effects, especially hypoglycaemia and bradycardia in the neonate and bradycardia in the foetus, may occur
• There is an increased risk of cardiac and pulmonary complications in the newborn in the post-natal period

Breastfeeding 

South African recommendations

• Contraindicated
• Propranolol is contraindicated for use while breastfeeding
• Propranolol is highly lipophilic and passes into breast milk

Recommendations in other jurisdictions

• Caution; not recommended
• Most beta-adrenoceptor blocking drugs, particularly lipophilic compounds like propranolol, will pass into breast milk although to a variable extent. Breastfeeding is therefore not recommended following administration of these compounds

Renal Impairment

• Caution; no dose adjustment recommended 

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Caution; dose adjustment recommended
  Dosage should not exceed 20mg three times daily; Monitor closely

Elderly

• Caution; no dose adjustment recommended
  Initiate at lower end of dosage range. Optimum dose should be individually determined according to clinical response

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - In certain sports
  
  Prohibited - In and out of competition:
  Archery (WA)
  Shooting (ISSF) (IPC)
  
  Prohibited - In competition:
  Automobile (FIA)
  Billiards (all disciplines) (WCBS)
  Darts (WDF)
  Golf (IGF)
  Skiing / Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe and snowboard halfpipe/big air
  Underwater sports (CMAS) in constant-weight apnoea with or without fins, dynamic apnoea with and without fins, free immersion apnoea, Jump Blue apnoea, spearfishing, static apnoea, target shooting and variable weight apnoea  

Central Nervous System Disorders

• Sleep disturbances
• Nightmares
• Depression
• Confusion
• Hallucinations
• Psychosis
• Mood changes  
• Memory loss
• Dizziness
• Paraesthesia  
• Myasthenia gravis like syndrome
• Headache
• Seizure
• Fatigue
• Lassitude
• Syncope

Cardiovascular Disorders

• Bradycardia
• Heart failure deterioration
• Precipitation of heart block
• Postural hypotension
• Worsening of attacks of angina pectoris
• Cold extremities
• Raynaud's syndrome
• Exacerbation of intermittent claudication

Respiratory Disorders

• Bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Constipation
• Dry mouth

Genitourinary Disorders

• Reduced glomerular filtration rate
• Reduced renal blood flow
• Sexual dysfunction

Endocrine and Metabolic Disorders

• Masking signs of thyrotoxicosis
• Hypoglycaemia
• Changes in lipid metabolism

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Purpura
• Psoriasiform skin reactions
• Exacerbation of psoriasis
• Rash

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Agranulocytosis

Sensory Disorders

• Visual disturbances
• Dry eyes
• Conjunctivitis

• Adrenaline
• Anaesthetics
• Antiarrhythmics
• Disopyramide
• Quinidine
• Flecainide
• Amiodarone
• Lidocaine
• Anticoagulants
• Warfarin
• Antidiabetic agents
• Insulin
• Antihypertensives
• Clonidine
• Moxonidine
• Prazosin
• Antimigraine agents
• Rizatriptan
• Ergotamine
• Dihydroergotamine
• Barbiturates
• Chlorpromazine
• Cimetidine  
• Hydralazine  
• Imipramine
• Monoamine oxidase inhibitors
• Non-steroidal anti-inflammatory drugs
• Rifampicin
• Selective serotonin reuptake inhibitors
• Theophylline
• Propafenone
• Thioridazine
• Dihydropyridine
• Calcium channel blockers
• Verapamil
• Diltiazem
• Nifedipine
• Nisoldipine
• Nicardipine
• Isradipine
• Lacidipine
• Diuretics
• Methyldopa
• Levodopa
• Tobacco
• Digitalis glycosides

None routine

Interference with laboratory tests

• Propranolol has been reported to interfere with the estimation of serum bilirubin by the diazo method and with determination of catecholamines by methods using fluorescence

Propranolol is a competitive antagonist at beta-1 and beta-2 adrenoreceptors.This inhibits sympathetic stimulation which results in a reduction in resting heart rate, cardiac output, systolic and diastolic blood pressure, and reflex orthostatic hypotension.

Film-coated tablet 10mg

• Inderal 10 (AstraZeneca) originator

Film-coated tablet 40mg

• Inderal 40(AstraZeneca) originator

Tablet 10mg

• Indoblok (Gulf Drug)
• Prodorol (Unimed)
• Pur-Bloka (Pharmacare)

Tablet 40mg

• Indoblok (Gulf Drug)
• Prodorol (Unimed)
• Pur-Bloka (Pharmacare)