AMIODARONE

Treatment should be initiated and normally monitored only under hospital or specialist supervision. Amiodarone should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. Posology The standard recommended dose is 5mg/kg bodyweight given by intravenous infusion over a period of 20 minutes to 2 hours.

This should be administered as a dilute solution in 250ml 5% w/v dextrose. 4). In extreme clinical emergency, the drug may, at the discretion of the clinician, be given as a slow injection of 150-300mg in 10-20ml 5%w/v dextrose over a minimum of 3 minutes.

This should not be repeated for at least 15 minutes. g. 4).

Cardiopulmonary resuscitation:

The recommended dose for ventricular fibrillations/pulseless ventricular tachycardia resistant to defibrillation is 300 mg (or 5 mg/kg body-weight) as a rapid injection. 5 mg/kg body-weight) IV dose may be considered if ventricular fibrillation persists.

e. 200mg three times a day). Amiodarone injection should then be phased out gradually.

Paediatric population:

The safety and efficacy of amiodarone in children and adolescents has not been established. 2. Due to the presence of benzyl alcohol, intravenous amiodarone is usually contraindicated in neonates and should be used with caution in infants and children up to 3 years old.

3). No controlled paediatric studies have been undertaken.

In published uncontrolled studies, effective doses for children were:

Loading dose: 5mg/kg body weight over 20 minutes to 2 hours Maintenance dose: 10 to 15mg/kg/day from a few hours to several days. If needed, oral therapy may be initiated concomitantly.

Elderly:

As with all patients, it is important that the minimum effective dose is used. Whilst there is no evidence that dosage requirements are different for this group of patients, they may be more susceptible to bradycardia and conduction defects if too high a dose is employed.

8). g. in an intensive care unit.

Method of administration:

For intravenous injection or infusion. 6.

The most common adverse drug effects reported with intravenous amiodarone hydrochloride are infusion phlebitis, bradycardia, and hypotension. Frequency of the adverse reaction listed below is defined according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data) Table 1: Frequency of the adverse reaction System Organ Class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to<1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) System Organ Class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to<1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and lymphatic system disorders In patients taking amiodarone there have been incidental findings of bone marrow granulomas.

The clinical significance of this is unknown -Neutropenia -Agranulocytosis Immune system disorders Anaphylacti c shock Angioedema (there have been some reports of angioedema, although exact frequencies are not known). 4). -Hypothyroidism Psychiatric disorders Delirium (including confusion) System Organ Class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to<1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Nervous system disorders Extrapyrami dal tremor Peripheral sensorimotor neuropathy and/or myopathy, usually reversible on withdrawal of the drug.

-Benign intracranial hypertension (pseudo- tumour cerebri) -Headache Eye disorders Microdeposits at the anterior surface of the cornea are found in almost every patient, which are usually limited to the area below the pupil. They may be associated with colored halos in dazzling light or blurred vision.

They usually regress 6-12 months after discontinuatio n of amiodarone hydrochloride. Optic neuropathy / neuritis that may progress to blindness. System Organ Class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to<1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Cardiac disorders Dose- dependent bradycardia - Severe bradycardia (in cases of sinus node dysfunction and in the elderly) or (more rarely) sinus arrest: this may necessitate discontinuati on of the treatment.

5). - Conduction disturbances (sinoatrial block, AV block). System Organ Class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to<1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Vascular disorders Hypotension and increased heart rate immediately following injection.

These are generally moderate and transient in nature. Cases of severe hypotension or shock have been reported following overdose or too rapid administrati on (bolus injection). 4). - Acute adult respiratory distress syndrome, sometimes with fatal sequelae.

- Bronchospas m and/or apnoea in patients with serious respiratory problems, especially patients with asthma. 5 to 3 times above normal) at the start of treatment, which is often transient in nature and resolves spontaneousl y upon lowering the dose.

4). System Organ Class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to<1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders Eczema Sweating - Urticaria.

- Severe skin reaction as toxic epidermal necrolysis (TEN)/Stevens- Johnson syndrome (SJS), bullous dermatitis and Drug reaction with eosinophilia and systematic symptoms (DRESS) Musculoskeletal and Connective Tissue Disorders Back pain Reproductive System and breast disorders Libido decreased General disorders and administration site conditions At the site of injection or infusion: pain, erythema, oedema, necrosis, extravasatio n, infiltration, inflammatio n, induration, thrombophle bitis, phlebitis, cellulitis, infection, pigmentatio n changes The excipient benzyl alcohol may cause hypersensitivity reactions.

4) A few rare cases with various clinical symptoms, indicative of hypersensitivity reactions, have been reported: vasculitis, reduced renal function with a rise in creatinine levels, thrombocytopenia, anaphylaxis. Reporting of suspected adverse […]

The prefilled syringes must be used with compatible needle-free connectors (NFCs). Using an incompatible NFC may lead to blockages, potentially delaying the delivery of emergency medication. To avoid such issues, ensure compatible NFCs are procured in advance and stored together with the Aurum range of prefilled syringes.

pdf Administration: Amiodarone injection should only be used in a special care unit under continuous monitoring (ECG and blood pressure). 8). Circulatory collapse may be precipitated by too rapid administration or overdosage (atropine has been used successfully in such patients presenting with bradycardia).

8). When repeated or continuous infusion is anticipated, administration by a central venous catheter is recommended. Amiodarone should not be mixed with other preparations in the same syringe and should not be injected with other preparations in the same line.

2). When given by infusion amiodarone hydrochloride may reduce drop size and, if appropriate, adjustments should be made to the rate of infusion. 5). 3). Too high a dosage may lead to severe bradycardia and to conduction disturbances with the appearance of an idioventricular rhythm, particularly in elderly patients or during digitalis therapy.

In these circumstances, amiodarone treatment should be withdrawn. If necessary beta-adrenostimulants or glucagon may be given. Because of the long half-life of amiodarone, if bradycardia is severe and symptomatic the insertion of a pacemaker should be considered.

Amiodarone has a low pro-arrhythmic effect. Onsets of new arrhythmias or worsening of treated arrhythmias, sometimes fatal, have been reported. It is important, but difficult to differentiate a lack of efficacy of the drug from a proarrhythmic effect, whether or not this is associated with a worsening of the cardiac condition.

8). Despite QT interval prolongation, amiodarone exhibits a low torsadogenic activity.

The pharmacological action of amiodarone induces ECG changes:

QT prolongation (related to prolonged repolarisation) with the possible development of U- waves and deformed T-waves; these changes do not reflect toxicity. Severe bradycardia and heart block after sofosbuvir Life-threatening cases of bradycardia and heart block have been observed when sofosbuvir- containing regimens are used in combination with amiodarone.

Bradycardia has generally occurred within hours to days, but later cases have been mostly observed up to 2 weeks after initiating HCV treatment. Amiodarone should only be used in patients on sofosbuvir-containing regimen when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.

Should concomitant use of amiodarone be considered necessary, it is recommended that patients undergo cardiac monitoring in an in-patient setting for the first 48 hours of coadministration, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.

Due to the long half-life of amiodarone, cardiac monitoring as outlined above should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on sofosbuvir- containing regimen.

All patients receiving amiodarone in combination with sofosbuvir-containing regimen should be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.

Primary graft dysfunction (PGD) post cardiac transplant:

In retrospective studies, amiodarone use in the transplant recipient prior to heart transplant has been associated with an increased risk of PGD. 8). Severe PGD may be irreversible. For patients who are on the heart transplant waiting list, consideration should be given to use an alternative antiarrhythmic drug as early as possible before transplant.

General anaesthesia:

Caution is advised in patients undergoing general anaesthesia, or receiving high dose oxygen therapy. 5). 8): Amiodarone may induce hyperthyroidism, particularly in patients with a personal history of thyroid disorders or patients who are taking/have previously taken oral amiodarone.

Serum ultrasensitive thyroid-stimulating hormone (usTSH) level should be measured when thyroid dysfunction is suspected. Thyroid function tests should be performed where appropriate prior to therapy in all patients. Amiodarone contains iodine and thus may interfere with radio-iodine uptake.

However, thyroid function tests (free-T3, free-T4, usTSH) remain interpretable. Amiodarone inhibits peripheral conversion of […]

1 (one pre-filled syringe contains approximately 112mg iodine). • Sinus bradycardia, sino-atrial heart block and sick sinus syndrome in patients without a pacemaker. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, amiodarone should be used only in specialized units in conjunction with a pacemaker.

4). 4). 6 All these above contra-indications do not apply to the use of amiodarone for cardiopulmonary resuscitation of shock resistant ventricular fibrillation.