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AMIODARONE HYDROCHLORIDE is a brand name for Amiodarone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral amiodarone is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used. Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
It is particularly important that the minimum effective dose be used. In all cases the patient´s management must be judged on the individual response and well being. The following dosage regimen is generally effective.
Initial stabilisation:
Treatment should be started with 200 mg, three times a day and may be continued for 1 week. The dosage should then be reduced to 200 mg, twice daily for a further week.
Maintenance:
After the initial period the dosage should be reduced to 200mg daily, or less if appropriate. Rarely, the patient may require a higher maintenance dose. The scored 100mg tablet should be used to titrate the minimum dosage required to maintain control of the arrhythmia.
The maintenance dose should be regularly reviewed, especially where this exceeds 200 mg daily.
General considerations Initial dosing:
A high dose is needed in order to achieve adequate tissue levels rapidly.
Maintenance:
Too high a dose during maintenance therapy can cause side effects which are believed to be related to high tissue levels of amiodarone and its metabolites. Amiodarone is strongly protein bound and has an average plasma half life of 50 days (reported range 20-100 days).
It follows that sufficient time must be allowed for a new distribution equilibrium to be achieved between adjustments of dosage. In patients with potentially lethal arrhythmias the long half life is a valuable safeguard, as omission of occasional doses does not significantly influence the overall therapeutic effect.
It is particularly important that the minimum effective dosage is used and the patient is monitored regularly to detect the clinical features of excess amiodarone dosage. Therapy may then be adjusted accordingly.
Dosage reduction/withdrawal:
Side effects slowly disappear as tissue levels fall. Following drug withdrawal, residual tissue bound amiodarone may protect the patient for up to a month. However, the likelihood of recurrence of arrhythmia during this period should be considered.
01%), not known (cannot be estimated from the available data). ) Nervous system disorders Nightmares, sleep disorders. Extrapyramidal tremor for which regression usually occurs after reduction of dose or withdrawal. 4) cerebellar ataxia, for which regression usually occurs after reduction of dose or withdrawal, Benign intracranial hypertension (pseudo- tumour cerebri)..
vertigo, headache parkinsonism, parosmia Gastrointestinal disorders benign gastrointestinal disorders (nausea, vomiting, dysgeusia) usually occurring with loading dosage and resolving with dose reduction Constipation Dry mouth Pancreatitis/ acute pancreatitis General disorders Granuloma, including bone marrow granuloma Blood and lymphatic system disorders: haemolytic anaemia, aplastic anaemia, thrombocytope nia.
In patients taking amiodarone there have been incidental findings of bone marrow granulomas. The clinical significance of this is unknown. Neutropenia, Agranulocytosis Skin and subcutaneous tissue disorders Photosensitivity . 4). slate grey or bluish pigmentations of light exposed skin, particularly the face,.
in case of prolonged treatment with high daily dosages, such pigmentations slowly disappears following discontinuation of treatment, eczema exfoliative dermatitis , erythema during radiotherapy, skin rashes, usually non- specific, alopecia, Urticaria, severe skin reactions sometimes fatal including toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome (SJS), bullous dermatitis and drug reaction with eosinophilia and systematic symptoms (DRESS).
Eye disorders corneal microdeposit s usually limited to the area under the pupil, which are usually only discernable by slit-lamp examination s. They may be associated with coloured halos in dazzling light or blurred vision. Corneal micro- deposits consist of complex lipid deposits and are reversible following discontinuati on of treatment.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. ). Because these reactions may be delayed, patients on long-term treatment should be carefully supervised.
As undesirable effects are usually dose-related, the minimum effective maintenance dose should be given. 8): 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.
Oral amiodarone is not contra-indicated in patients with latent or manifest heart failure but caution should be exercised as, occasionally, existing heart failure may be worsened. In such cases, Amiodarone may be used with other appropriate therapies.
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. In the elderly, heart rate may decrease markedly. Treatment should be discontinued in case of onset of 2nd or 3rd degree A-V block, sino-atrial block or bifascicular block.
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.
5. 8). Despite QT interval prolongation, amiodarone exhibits a low torsadogenic activity. Before starting amiodarone, it is recommended to perform an ECG and serum potassium measurement. Monitoring of ECG is recommended during treatment.
1. (One 200 mg tablet contains approximately 75 mg iodine). Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Amiodarone should be used only in conjunction with a pacemaker.
Evidence or history of thyroid dysfunction. Thyroid function tests should be performed prior to therapy in all patients. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Amiodarone in United Kingdom.
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Paediatric population:
The safety and efficacy of amiodarone in children has not been established. 2 but no recommendation on posology can be made.
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.
Particular attention should be paid to monitoring thyroid function. ) Method of administration: Amiodarone 200mg is for oral administration.
4) of amiodarone. 4). bronchospasm in patients with severe respiratory failure and especially in asthmatic patients. 5). 5 to 3 times normal range), occurring at the beginning of therapy. It may return to normal with dose reduction or even spontaneously.
Acute liver disorders with high serum transaminases and/or jaundice, including hepatic failure, which are sometimes fatal Chronic liver disease (pseudo alcoholic hepatitis, cirrhosis), sometimes fatal. 4) Hypothyroidism, hyperthyroidism, sometimes fatal Syndrome of inappropriate antidiuretic hormone secretion (SIADH) Immune system disorders: Angioneurotic oedema (Quincke’s Oedema).
Anaphylactic shock/, anaphylactoid reaction including shock Investigations Increase in blood creatinine. 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
Amiodarone may increase the defibrillation threshold and/or pacing threshold in patients with an implantable cardioverter defibrillator or a pacemaker, which may adversely affect the efficacy of the device. Regular tests are recommended to ensure the proper function of the device after initiation of treatment or change in posology.
5): 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 week 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.
8): Onset of dysponea or non- productive cough may be related to pulmonary toxicity (hypersensitivity pneumonitis, alveolar/interstitial pneumonitis or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonitis). Presenting features can include dyspnoea (which may be severe and unexplained by the current cardiac status), non-productive cough and deterioration in general health (fatigue, weight loss and fever).
The onset is usually slow but may be rapidly progressive. Whilst the majority of cases have been reported with long term therapy, a few have occurred soon after starting treatment. Patients should be carefully evaluated clinically and consideration given to chest X- ray before starting therapy.
During treatment, if pulmonary toxicity is suspected, this should be repeated and associated with lung function testing including where possible measurement of transfer factor. However, initial radiological changes may be difficult to distinguish from pulmonary venous congestion and high-definition computerised tomography scans may therefore be more useful than chest x-rays in confirming a diagnosis.
Pulmonary […]