Drug reference

Amiodarone hydrochloride

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 134, 135

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Treatment of arrhythmias, particularly when other drugs are ineffective or contra-indicated (including paroxysmal supraventricular, nodal and ventricular tachycardias, atrial fibrillation and flutter, ventricular fibrillation, and tachyarrhythmias associated with Wolff- Parkinson-White syndrome) (initiated in hospital or under specialist supervision) ▶BY MOUTH ▶Adult: 200 mg 3 times a day for 1 week, then reduced to 200 mg twice daily for a further week, followed by maintenance dose, usually 200 mg daily or the minimum dose required to control arrhythmia ▶BY INTRAVENOUS INFUSION ▶Adult: Initially 5 mg/kg, to be given over 20–120 minutes with ECG monitoring, subsequent infusions given if necessary according to response; maximum 1.2 g per day Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation (for cardiopulmonary resuscitation) ▶INITIALLY BY INTRAVENOUS INJECTION ▶Adult: Initially 300 mg, dose to be considered after administration of adrenaline, dose should be given from a pre-ﬁlled syringe or diluted in 20 mL Glucose 5%, then (by intravenous injection) 150 mg if required, followed by (by intravenous infusion) 900 mg/24 hours

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Contra Indications

GENERAL CONTRA-INDICATIONS Avoid in severe conduction disturbances (unless pacemaker ﬁtted). avoid in sinus node disease (unless pacemaker ﬁtted). iodine sensitivity. sino-atrial heart block (except in cardiac arrest). sinus bradycardia (except in cardiac arrest). thyroid dysfunction SPECIFIC CONTRA-INDICATIONS ▶With intravenous use Avoid bolus injection in cardiomyopathy. avoid bolus injection in congestive heart failure. avoid in circulatory collapse. avoid in severe arterial hypotension. avoid in severe respiratory failure

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Cautions

GENERAL CAUTIONS Acute porphyrias p. 1120. conduction disturbances (in excessive dosage). elderly. heart failure. hypokalaemia. severe bradycardia (in excessive dosage) SPECIFIC CAUTIONS ▶With intravenous use moderate and transient fall in blood pressure (circulatory collapse precipitated by rapid administration or overdosage). severe hepatocellular toxicity CAUTIONS, FURTHER INFORMATION ▶Elderly Prescription potentially inappropriate (STOPP criteria) as ﬁrst-line antiarrhythmic therapy in supraventricular tachyarrhythmias (higher risk of side- effects than beta-blockers, digoxin, verapamil or diltiazem). See also Prescribing in the elderly p. 33.

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Safety

Important Safety Information

MHRA/CHM ADVICE: SOFOSBUVIR WITH DACLATASVIR; SOFOSBUVIR AND LEDIPASVIR (MAY 2015); SIMEPREVIR WITH SOFOSBUVIR (AUGUST 2015): RISK OF SEVERE BRADYCARDIA AND HEART BLOCK WHEN TAKEN WITH AMIODARONE Avoid concomitant use unless other antiarrhythmics cannot be given.

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Interactions

→Appendix 1: antiarrhythmics

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Side Effects

GENERAL SIDE-EFFECTS ▶Common or very common Arrhythmias. hepatic disorders. hyperthyroidism. nausea. respiratory disorders. skin reactions ▶Rare or very rare Bronchospasm (in patients with severe respiratory failure). headache. idiopathic intracranial hypertension. nerve disorders. SIADH ▶Frequency not known Angioedema. confusion. delirium. pancreatitis. severe cutaneous adverse reactions (SCARs) SPECIFIC SIDE-EFFECTS ▶Common or very common ▶With oral use Constipation. corneal deposits. hypothyroidism. movement disorders. photosensitivity reaction. sleep disorders. taste altered. vomiting ▶With parenteral use Hypotension (following rapid injection) ▶Uncommon ▶With oral use Cardiac conduction disorders. dry mouth. myopathy (usually reversible on discontinuation). peripheral neuropathy (usually reversible on discontinuation) ▶Rare or very rare ▶With oral use Alopecia. aplastic anaemia. epididymo- orchitis. erectile dysfunction. haemolytic anaemia. pulmonary haemorrhage. thrombocytopenia. vertigo ▶With parenteral use Hot ﬂush. hyperhidrosis ▶Frequency not known ▶With oral use Altered smell sensation. appetite decreased. parkinsonism. vasculitis ▶With parenteral use Agranulocytosis. libido decreased. neutropenia SIDE-EFFECTS, FURTHER INFORMATION Corneal microdeposits Patients taking amiodarone may develop corneal microdeposits (reversible on withdrawal of treatment). However, if vision is impaired or if optic neuritis or optic neuropathy occur, amiodarone must be stopped to prevent blindness and expert advice sought. Thyroid function Amiodarone contains iodine and can cause disorders of thyroid function; both hypothyroidism and hyperthyroidism can occur. Hypothyroidism can be treated with replacement therapy without withdrawing amiodarone if it is essential; careful supervision is required. Hepatotoxicity Amiodarone is also associated with hepatotoxicity and treatment should be discontinued if severe liver function abnormalities or clinical signs of liver disease develop. Pulmonary toxicity Pneumonitis should always be suspected if new or progressive shortness of breath or cough develops in a patient taking amiodarone.

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Pregnancy

Possible risk of neonatal goitre; use only if no alternative.

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Breast Feeding

Avoid; present in milk in signiﬁcant amounts; theoretical risk of neonatal hypothyroidism from release of iodine.

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Monitoring Requirements

▶Thyroid function tests should be performed before treatment and then every 6 months. Clinical assessment of thyroid function alone is unreliable. Thyroxine (T4) may be raised in the absence of hyperthyroidism; therefore tri- iodothyronine (T3), T4, and thyroid-stimulating hormone (thyrotrophin, TSH) should all be measured. A raised T3 and T4 with a very low or undetectable TSH concentration suggests the development of thyrotoxicosis. ▶Liver function tests required before treatment and then every 6 months. ▶Serum potassium concentration should be measured before treatment. ▶Chest x-ray required before treatment. ▶If concomitant use of amiodarone with sofosbuvir and daclatasvir, simeprevir and sofosbuvir, or sofosbuvir and ledipasvir cannot be avoided because other anti- arrhythmics are not tolerated or contra-indicated, patients should be closely monitored, particularly during the ﬁrst weeks of treatment. Patients at high risk of bradycardia should be monitored continuously for 48 hours in an appropriate clinical setting after starting concomitant treatment. Patients who have stopped amiodarone within the last few months and need to start sofosbuvir and daclatasvir, simeprevir and sofosbuvir, or sofosbuvir and ledipasvir should be monitored. ▶With intravenous use ECG monitoring and resuscitation facilities must be available. Monitor liver transaminases closely.

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Dose and formulations

Directions For Administration

▶With intravenous use For intravenous infusion (Cordarone X ®), give continuously or intermittently in Glucose 5%. Suggested initial infusion volume 250 mL given over 20–120 minutes; for repeat infusions up to 1.2 g in max. 500 mL; should not be diluted to less than 600 micrograms/mL. See cardio-pulmonary resuscitation for details of infusion in extreme emergency. Incompatible with Sodium Chloride infusion ﬂuids; avoid equipment containing the plasticizer di-2-ethylhexphthalate (DEHP). ▶With oral use For administration by mouth, tablets may be crushed and dispersed in water; injection solution should not be given orally (irritant).

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Tablet CAUTIONARY AND ADVISORY LABELS 11 ▶Amiodarone hydrochloride (Non-proprietary) Amiodarone hydrochloride 100 mg Amiodarone 100mg tablets | 28 tablet P £4.25 DT = £1.63 Amiodarone hydrochloride 200 mg Amiodarone 200mg tablets | 28 tablet P £7.80 DT = £1.91 ▶Cordarone X (Sanofi) Amiodarone hydrochloride 100 mg Cordarone X 100 tablets | 28 tablet P £4.28 DT = £1.63 Amiodarone hydrochloride 200 mg Cordarone X 200 tablets | 28 tablet P £6.99 DT = £1.91 Solution for injection EXCIPIENTS: May contain Benzyl alcohol ▶Amiodarone hydrochloride (Non-proprietary) Amiodarone hydrochloride 30 mg per 1 ml Amiodarone 300mg/10ml solution for injection pre-filled syringes | 1 pre-filled disposable injection P £14.68 DT = £14.68 Amiodarone hydrochloride 50 mg per 1 ml Amiodarone 150mg/3ml concentrate for solution for injection ampoules | 5 ampoule P £7.75 (Hospital only) | 10 ampoule P £17.00 ▶Cordarone X (Sanofi) Amiodarone hydrochloride 50 mg per 1 ml Cordarone X 150mg/3ml solution for injection ampoules | 6 ampoule P £9.60

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Clinical care

Patient And Carer Advice

Because of the possibility of phototoxic reactions, patients should be advised to shield the skin from light during treatment and for several months after discontinuing amiodarone; a wide-spectrum sunscreen to protect against both long-wave ultraviolet and visible light should be used. If taking amiodarone with concomitant sofosbuvir and daclatasvir, simeprevir and sofosbuvir, or sofosbuvir and ledipasvir, patients and their carers should be told how to recognise signs and symptoms of bradycardia and heart block and advised to seek immediate medical attention if symptoms such as shortness of breath, light-headedness, palpitations, fainting, unusual tiredness or chest pain develop.

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Dose text by age group

Adult

200 mg 3 times a day for 1 week, then reduced to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 134

Adult

Initially 5 mg/kg, to be given over

First-line fragment. Read the complete Indications and Dose section above.

PDF page 134

Adult

Initially 300 mg, dose to be considered after

First-line fragment. Read the complete Indications and Dose section above.

PDF page 134

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Amiodarone hydrochloride

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 134, 135

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 134

Contra Indications

PDF page 134

Cautions

PDF page 134

Safety

Important Safety Information

PDF page 134

Interactions

→Appendix 1: antiarrhythmics

PDF page 134

Side Effects

PDF page 134

Pregnancy

Possible risk of neonatal goitre; use only if no alternative.

PDF page 134

Breast Feeding

Avoid; present in milk in signiﬁcant amounts; theoretical risk of neonatal hypothyroidism from release of iodine.

PDF page 134

Monitoring Requirements

PDF pages 134, 135

Dose and formulations

Directions For Administration

PDF page 135

Medicinal Forms

PDF page 135

Clinical care

Patient And Carer Advice

PDF page 135

Dose text by age group

Adult

200 mg 3 times a day for 1 week, then reduced to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 134

Adult

Initially 5 mg/kg, to be given over

First-line fragment. Read the complete Indications and Dose section above.

PDF page 134

Adult

Initially 300 mg, dose to be considered after

First-line fragment. Read the complete Indications and Dose section above.

PDF page 134

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.