Drugs List

Therapeutic Indications

Uses

Atrial fibrillation
Atrial flutter
Nodal tachycardias
Supra-ventricular tachycardia
Ventricular fibrillation - recurrent
Ventricular tachycardia
Wolff-Parkinson-White syndrome

Administration

For intravenous infusion or slow intravenous injection.

Intravenous infusion is preferred to bolus injection due to the haemodynamic effects sometimes associated with rapid injection. Amiodarone may be used prior to DC conversion.

Thrombophlebitis can occur if amiodarone is injected regularly or infused for prolonged periods into a peripheral vein. When repeated or continuous infusion is anticipated, administration by a central venous catheter is recommended.

If a peripheral line is used, it is important to ensure the line is patent to avoid extravasation, either by virtue of successful administration of other drugs by the same line, or, if this administration is the first by the line, prior flushing to ensure the patency of the line.

Intravenous injections should be given slowly since rapid intravenous administration has been associated with circulatory collapse, anaphylactic shock, hot flushes, sweating and nausea. A moderate and transient reduction in blood pressure may occur.

When given by infusion, amiodarone reduces the drop size, so counting drops per minute to calculate the rate of infusion will under-dose the patient. If appropriate, adjustments should be made to the rate of infusion. Use of a volumetric infusion pump is recommended to administer amiodarone infusion.

Contraindications

Hypersensitivity to benzyl alcohol
Acute porphyria
Breastfeeding
Circulatory failure
Long QT syndrome
Non-paced severe cardiac conduction defect
Non-paced sinus node dysfunction
Pregnancy
Severe hypotension
Severe respiratory impairment
Sinoatrial exit block
Sinus bradycardia
Thyroid dysfunction
Torsade de pointes

Precautions and Warnings

Children under 3 years
Elderly
Family history of long QT syndrome
Family history of thyroid dysfunction
Cardiac failure
Cardiomyopathy
Electrolyte imbalance
History of thyroid disorder
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypotension
Respiratory impairment

Anaesthetist should be made aware patient is taking this medication
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
No absolute contraindications for emergency use
Treatment to be initiated by specialist
Contains benzyl alcohol
Consider central venous admin if inflammation of peripheral vein occurs
Consider chest x-ray prior to initiating therapy
Monitor hepatic function before and at 6 monthly intervals during treatment
Monitor serum potassium levels before treatment
Perform ECG before and during treatment
Annual ophthalmological examination recommended
If pulmonary toxicity suspected do chest x-ray, and lung function tests
Monitor blood pressure and ECG continuously throughout treatment
Monitor patient for some months after discontinuing treatment
Monitor respiratory function
Monitor serum electrolytes
Monitor thyroid function regularly
Only use when facilities exist for cardiac monitoring or defibrillation
Long half life.Drug interactions possible weeks after treatment has stopped
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Withdraw if severe bradycardia or idioventricular rhythm occur
May cause changes to ECG
Discontinue if 2nd or 3rd degree AV, sinoatrial or bifascicular block occur
Discontinue if hyperthyroidism occurs
Discontinue if jaundice or other evidence of hepatic impairment occurs
Discontinue if pulmonary toxicity occurs
Maintain treatment at the lowest effective dose
Advise patient to moderate alcohol intake during treatment
Advise patient grapefruit products may increase plasma level
Female: Contraception required during and for 6 months after treatment
Avoid direct exposure to sunlight

Intravenous injections should be given slowly since rapid intravenous administration has been associated with circulatory collapse, anaphylactic shock, hot flushes, sweating and nausea. A moderate and transient reduction in blood pressure may occur. Atropine may be required in such patients with bradycardia. Patients with respiratory failure (notably asthmatics) may experience bronchospasm and /or apnoea. Isolated cases of anaphylactic shock have been reported.

If subsequent oral therapy is considered necessary patients should be carefully supervised as amiodarone may cause delayed serious adverse reactions including damage to the eyes, heart, lungs, liver, thyroid gland, skin and peripheral nervous system.

Monitoring of thyroid function (ultrasensitive TSH) is recommended before start of treatment in all patients, then six monthly thereafter. Monitoring should be continued for some months after discontinuation of treatment particularly in the elderly.

Anti-thyroid treatment has been undertaken for the use of severe thyroid hyperactivity, large doses may be required initially. Anti-thyroid therapy may not always be effective and concomitant high dose corticosteroid therapy may be required for several weeks.

Severe hepatocellular insufficiency may occur within the first 24 hours of IV amiodarone administration and may sometimes be fatal.

Pulmonary toxicity should be suspected if new or progressive shortness of breath or cough develops in a patient on amiodarone. The onset may be slow but may be rapidly progressive. It has been mostly reported with long term use but a few cases have presented shortly after beginning treatment.

Pregnancy and Lactation

Pregnancy

Amiodarone is contraindicated during pregnancy, except in exceptional circumstances.

Amiodarone and its metabolite desethylamiodarone both cross the placenta. Most frequent complications include impaired growth, preterm birth and impaired function of the thyroid gland in newborn babies. Hypothyroidism, bradycardia and prolonged QT intervals were observed in approximately 10% of newborns. Isolated cases of an increased thyroid gland or cardiac murmurs were found.

Due to the half-life of amiodarone, treatment should be discontinued several months before conception to prevent foetal exposure. Schaefer (2007) suggests that if exposure occurs before 12 weeks gestation (when the foetal thyroid gland begins to function), adverse effects on the foetal thyroid function should be ruled out with an ultrasound scan. Newborns who were exposed in utero should have their thyroid function monitored.

Hale (2010) concludes it has a high rate of toxicity and should not be given to pregnant mothers unless critically required.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Amiodarone is contraindicated during breastfeeding.

Amiodarone is excreted into the breast milk in significant quantities.

The iodine released by amiodarone could have cardiac or thyroid effects. There is one report of neonatal hypothyroidism. Due to the long half life of amiodarone, if amiodarone was discontinued at birth, amiodarone would continue to be excreted for days to weeks. If neonatal hypothyroidism develops, treatment should be promptly initiated. Only use amiodarone in nursing mothers under exceptional circumstances and the infant should be monitored for cardiovascular and thyroid function.

If the mother develops hypothyroidism her milk supply may be diminished.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute hepatic disorders
Adult respiratory distress syndrome
Alopecia
Anaphylactic shock
Anaphylaxis
Angina
Angioedema
Aplastic anaemia
Apnoea
Arrhythmias
Asthenia
Ataxia
Atrioventricular block
Back pain
Benign intracranial hypertension
Blistering
Blurred vision
Bone marrow granuloma
Bradycardia
Bronchiolitis obliterans
Bronchospasm
Burning sensation
Cardiac arrest
Chronic hepatic disease
Circulatory collapse
Cirrhosis
Conduction disturbances
Corneal microdeposits (reversible)
Cough
Dyspnoea
ECG changes
Epididymo-orchitis
Erythema
Exfoliative dermatitis
Fatigue
Fever
Haemolytic anaemia
Headache
Hepatic failure
Hepatitis
Hot flushes
Hypersensitivity reactions
Hyperthyroidism
Hypotension
Hypothyroidism
Impotence
Increases in serum transaminases (transient)
Injection site reactions
Interstitial pneumonitis
Jaundice
Local pain (injection site)
Maculopapular rash
Myopathy
Nausea
Nightmares
Optic neuritis
Optic neuropathy
Pancreatitis
Paraesthesia
Peripheral neuropathy
Photosensitivity
Phototoxicity
Pleuritis
Pneumonia
Pneumonitis
Possible alteration of thyroid function tests
Pro-arrhythmic effects
Prolongation of QT interval
Pulmonary alveolitis
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary toxicity
Rash
Respiratory failure
Serum creatinine increased
Sino-atrial block
Sinus arrest
Skin tingling
Slate-grey skin discolouration
Sleep disturbances
Sweating
Taste disturbances
Thrombocytopenia
Thrombophlebitis
Thyrotoxicosis
Torsades de pointes
Tremor
Urticaria
Vasculitis
Vertigo
Visual haloes
Vomiting
Weight changes
Weight loss

Presentation

Injections of amiodarone

Drugs List

Therapeutic Indications

Uses

Atrial fibrillation
Atrial flutter
Nodal tachycardias
Supra-ventricular tachycardia
Ventricular fibrillation - recurrent
Ventricular tachycardia
Wolff-Parkinson-White syndrome

Dosage

Adults

Children

Neonates

Additional Dosage Information

Administration

For intravenous infusion or slow intravenous injection.

Intravenous infusion is preferred to bolus injection due to the haemodynamic effects sometimes associated with rapid injection. Amiodarone may be used prior to DC conversion.

Thrombophlebitis can occur if amiodarone is injected regularly or infused for prolonged periods into a peripheral vein. When repeated or continuous infusion is anticipated, administration by a central venous catheter is recommended.

If a peripheral line is used, it is important to ensure the line is patent to avoid extravasation, either by virtue of successful administration of other drugs by the same line, or, if this administration is the first by the line, prior flushing to ensure the patency of the line.

Intravenous injections should be given slowly since rapid intravenous administration has been associated with circulatory collapse, anaphylactic shock, hot flushes, sweating and nausea. A moderate and transient reduction in blood pressure may occur.

When given by infusion, amiodarone reduces the drop size, so counting drops per minute to calculate the rate of infusion will under-dose the patient. If appropriate, adjustments should be made to the rate of infusion. Use of a volumetric infusion pump is recommended to administer amiodarone infusion.

Contraindications

Hypersensitivity to benzyl alcohol
Acute porphyria
Breastfeeding
Circulatory failure
Long QT syndrome
Non-paced severe cardiac conduction defect
Non-paced sinus node dysfunction
Pregnancy
Severe hypotension
Severe respiratory impairment
Sinoatrial exit block
Sinus bradycardia
Thyroid dysfunction
Torsade de pointes

Precautions and Warnings

Children under 3 years
Elderly
Family history of long QT syndrome
Family history of thyroid dysfunction
Cardiac failure
Cardiomyopathy
Electrolyte imbalance
History of thyroid disorder
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypotension
Respiratory impairment

Anaesthetist should be made aware patient is taking this medication
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
No absolute contraindications for emergency use
Treatment to be initiated by specialist
Contains benzyl alcohol
Consider central venous admin if inflammation of peripheral vein occurs
Consider chest x-ray prior to initiating therapy
Monitor hepatic function before and at 6 monthly intervals during treatment
Monitor serum potassium levels before treatment
Perform ECG before and during treatment
Annual ophthalmological examination recommended
If pulmonary toxicity suspected do chest x-ray, and lung function tests
Monitor blood pressure and ECG continuously throughout treatment
Monitor patient for some months after discontinuing treatment
Monitor respiratory function
Monitor serum electrolytes
Monitor thyroid function regularly
Only use when facilities exist for cardiac monitoring or defibrillation
Long half life.Drug interactions possible weeks after treatment has stopped
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Withdraw if severe bradycardia or idioventricular rhythm occur
May cause changes to ECG
Discontinue if 2nd or 3rd degree AV, sinoatrial or bifascicular block occur
Discontinue if hyperthyroidism occurs
Discontinue if jaundice or other evidence of hepatic impairment occurs
Discontinue if pulmonary toxicity occurs
Maintain treatment at the lowest effective dose
Advise patient to moderate alcohol intake during treatment
Advise patient grapefruit products may increase plasma level
Female: Contraception required during and for 6 months after treatment
Avoid direct exposure to sunlight

Intravenous injections should be given slowly since rapid intravenous administration has been associated with circulatory collapse, anaphylactic shock, hot flushes, sweating and nausea. A moderate and transient reduction in blood pressure may occur. Atropine may be required in such patients with bradycardia. Patients with respiratory failure (notably asthmatics) may experience bronchospasm and /or apnoea. Isolated cases of anaphylactic shock have been reported.

If subsequent oral therapy is considered necessary patients should be carefully supervised as amiodarone may cause delayed serious adverse reactions including damage to the eyes, heart, lungs, liver, thyroid gland, skin and peripheral nervous system.

Monitoring of thyroid function (ultrasensitive TSH) is recommended before start of treatment in all patients, then six monthly thereafter. Monitoring should be continued for some months after discontinuation of treatment particularly in the elderly.

Anti-thyroid treatment has been undertaken for the use of severe thyroid hyperactivity, large doses may be required initially. Anti-thyroid therapy may not always be effective and concomitant high dose corticosteroid therapy may be required for several weeks.

Severe hepatocellular insufficiency may occur within the first 24 hours of IV amiodarone administration and may sometimes be fatal.

Pulmonary toxicity should be suspected if new or progressive shortness of breath or cough develops in a patient on amiodarone. The onset may be slow but may be rapidly progressive. It has been mostly reported with long term use but a few cases have presented shortly after beginning treatment.

Pregnancy and Lactation

Pregnancy

Amiodarone is contraindicated during pregnancy, except in exceptional circumstances.

Amiodarone and its metabolite desethylamiodarone both cross the placenta. Most frequent complications include impaired growth, preterm birth and impaired function of the thyroid gland in newborn babies. Hypothyroidism, bradycardia and prolonged QT intervals were observed in approximately 10% of newborns. Isolated cases of an increased thyroid gland or cardiac murmurs were found.

Due to the half-life of amiodarone, treatment should be discontinued several months before conception to prevent foetal exposure. Schaefer (2007) suggests that if exposure occurs before 12 weeks gestation (when the foetal thyroid gland begins to function), adverse effects on the foetal thyroid function should be ruled out with an ultrasound scan. Newborns who were exposed in utero should have their thyroid function monitored.

Hale (2010) concludes it has a high rate of toxicity and should not be given to pregnant mothers unless critically required.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Amiodarone is contraindicated during breastfeeding.

Amiodarone is excreted into the breast milk in significant quantities.

The iodine released by amiodarone could have cardiac or thyroid effects. There is one report of neonatal hypothyroidism. Due to the long half life of amiodarone, if amiodarone was discontinued at birth, amiodarone would continue to be excreted for days to weeks. If neonatal hypothyroidism develops, treatment should be promptly initiated. Only use amiodarone in nursing mothers under exceptional circumstances and the infant should be monitored for cardiovascular and thyroid function.

If the mother develops hypothyroidism her milk supply may be diminished.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute hepatic disorders
Adult respiratory distress syndrome
Alopecia
Anaphylactic shock
Anaphylaxis
Angina
Angioedema
Aplastic anaemia
Apnoea
Arrhythmias
Asthenia
Ataxia
Atrioventricular block
Back pain
Benign intracranial hypertension
Blistering
Blurred vision
Bone marrow granuloma
Bradycardia
Bronchiolitis obliterans
Bronchospasm
Burning sensation
Cardiac arrest
Chronic hepatic disease
Circulatory collapse
Cirrhosis
Conduction disturbances
Corneal microdeposits (reversible)
Cough
Dyspnoea
ECG changes
Epididymo-orchitis
Erythema
Exfoliative dermatitis
Fatigue
Fever
Haemolytic anaemia
Headache
Hepatic failure
Hepatitis
Hot flushes
Hypersensitivity reactions
Hyperthyroidism
Hypotension
Hypothyroidism
Impotence
Increases in serum transaminases (transient)
Injection site reactions
Interstitial pneumonitis
Jaundice
Local pain (injection site)
Maculopapular rash
Myopathy
Nausea
Nightmares
Optic neuritis
Optic neuropathy
Pancreatitis
Paraesthesia
Peripheral neuropathy
Photosensitivity
Phototoxicity
Pleuritis
Pneumonia
Pneumonitis
Possible alteration of thyroid function tests
Pro-arrhythmic effects
Prolongation of QT interval
Pulmonary alveolitis
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary toxicity
Rash
Respiratory failure
Serum creatinine increased
Sino-atrial block
Sinus arrest
Skin tingling
Slate-grey skin discolouration
Sleep disturbances
Sweating
Taste disturbances
Thrombocytopenia
Thrombophlebitis
Thyrotoxicosis
Torsades de pointes
Tremor
Urticaria
Vasculitis
Vertigo
Visual haloes
Vomiting
Weight changes
Weight loss

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2013

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Injectable Medicines Administration Guide, 3rd edition (2010) UCL NHS Foundation Trust. Wiley-Blackwell, Oxford.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Cordarone X Intravenous. Sanofi. Revised January 2013.

Summary of Product Characteristics: Amiodarone Injection Minijet 30mg/ml. International Medication Systems (UK) Ltd. Revised October 2012.

Summary of Product Characteristics: Amiodarone Hydrochloride 50mg/ml. Hameln pharmaceuticals ltd. Revised September 2012.

NAPOS; The Drug Database for Acute Porphyria.
Available at: https://www.drugs-porphyria.org/index.php
Amiodarone Last revised: September 25, 2009.
Last accessed: October 17, 2013.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 October 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Amiodarone Last revised: September 7, 2013
Last accessed: October 17, 2013.