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CORDARONE X 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 hydrochloride 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…
Verbatim from this product's MHRA label. Tap a section to expand.
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 200 mg daily, or less if appropriate. Rarely, the patient may require a higher maintenance dose.
The scored 100 mg 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. 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.
01%), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Very rare: • haemolytic anaemia • aplastic anaemia • thrombocytopenia. In patients taking amiodarone there have been incidental findings of bone marrow granulomas. The clinical significance of this is unknown. Not known: • neutropenia • agranulocytosis.
Cardiac disorders:
Common: • bradycardia, generally moderate and dose-related. 4) Very rare: • marked bradycardia or sinus arrest in patients with sinus node dysfunction and/or in elderly patients. 4): Common: • hypothyroidism • hyperthyroidism, sometimes fatal Very rare: • syndrome of inappropriate antidiuretic hormone secretion (SIADH) Eye disorders: Very common: • corneal microdeposits usually limited to the area under the pupil, which are usually only discernable by slit-lamp examinations.
They may be associated with colored halos in dazzling light or blurred vision. Corneal micro-deposits consist of complex lipid deposits and are reversible following discontinuation of treatment. The deposits are considered essentially benign and do not require discontinuation of amiodarone.
4).
Gastrointestinal disorders:
Very common: • benign gastrointestinal disorders (nausea, vomiting, dysgeusia) usually occurring with loading dosage and resolving with dose reduction. 5 to 3 times normal range), occurring at the beginning of therapy. It may return to normal with dose reduction or even spontaneously.
Common: • acute liver disorders with high serum transaminases and/or jaundice, including hepatic failure, which are sometimes fatal Very rare: • chronic liver disease (pseudo alcoholic hepatitis, cirrhosis), sometimes fatal.
8). Because these reactions may be delayed, patients on long-term treatment should be carefully supervised and reviewed regularly. As undesirable effects are usually dose-related, the minimum effective maintenance dose should be given.
8). 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 hydrochloride 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 hydrochloride 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 hydrochloride 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.
• 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 hydrochloride should be used only in conjunction with a pacemaker.
• Evidence or history of thyroid dysfunction. Thyroid function tests should be performed in all patients prior to therapy. • Known hypersensitivity to iodine or to amiodarone, or to any of the excipients. (One 200 mg tablet contains approximately 75 mg iodine).
5). 6). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8). Amiodarone hydrochloride 200 mg tablets is for oral administration.
Immune system disorders:
Not known: • Angioneurotic oedema (Quincke’s Oedema) • Anaphylactic shock/anaphylactoid reaction including shock Investigations: Very rare: increase in blood creatinine.
Metabolism and nutrition disorders:
Not known: • decreased appetite Musculoskeletal and connective tissue disorders: Not known: • lupus like syndrome Nervous system disorders: Common: • extrapyramidal tremor, for which regression usually occurs after reduction of dose or withdrawal • nightmares • sleep disorders.
4). Very rare: • cerebellar ataxia, for which regression usually occurs after reduction of dose or withdrawal • benign intracranial hypertension (pseudo- tumor cerebri) • headache • vertigo.
Not known: • parkinsonism • parosmia Psychiatric disorders:
Common: • libido decreased Not known: • confusional state/delirium • hallucination Reproductive system and breast disorders: Very rare: • epididymo-orchitis • impotence. 4). 5). 4). Common: • slate grey or bluish pigmentations of light-exposed skin, particularly the face, in case of prolonged treatment with high daily dosages; such pigmentations slowly disappear following treatment discontinuation.
• Eczema Very rare: • erythema during the course of radiotherapy • skin rashes, usually non- specific • exfoliative dermatitis • alopecia Not known: • urticaria • severe skin reactions sometimes fatal including toxic epidermal • necrolysis/Stevens-Johnson syndrome • bullous dermatitis and drug reaction with eosinophilia and systematic symptoms Vascular disorders: Very rare: • vasculitis.
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.
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 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.
8): Amiodarone may induce hypothyroidism or hyperthyroidism, particularly in patients with a personal history of thyroid disorders. Clinical and biological [including ultrasensitive TSH (usTSH)] monitoring should be performed prior to therapy in all patients.
Monitoring should be carried out during treatment, at six-monthly intervals, and for several months following its discontinuation. This is particularly important in the elderly. In patients whose history indicates an increased risk of thyroid dysfunction, regular assessment is recommended.
Serum usTSH level should be measured when thyroid dysfunction is suspected. 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 levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, free-T3 being slightly decreased or even normal) in clinically euthyroid patients.
There is no reason in such cases to discontinue amiodarone treatment if there is no clinical or further biological (usTSH) evidence of thyroid disease.
Hypothyroidism:
Hypothyroidism should be suspected if the following […]