Drug Action
Dronedarone is a multi-channel blocking anti-arrhythmic drug. Cardiovascular system
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Drug reference
Dronedarone is a multi-channel blocking anti-arrhythmic drug. Cardiovascular system
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Maintenance of sinus rhythm after cardioversion in clinically stable patients with paroxysmal or persistent atrial fibrillation, when alternative treatments are unsuitable (initiated under specialist supervision) ▶BY MOUTH ▶Adult: 400 mg twice daily
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Atrial conduction defects. bradycardia. complete bundle branch block. distal block. existing or previous heart failure or left ventricular systolic dysfunction. haemodynamically unstable patients. liver toxicity associated with previous amiodarone use. lung toxicity associated with previous amiodarone use. permanent atrial fibrillation. prolonged QT interval. second- or third- degree AV block. sick sinus syndrome (unless pacemaker fitted). sinus node dysfunction
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Coronary artery disease. correct hypokalaemia and hypomagnesaemia before starting and during treatment
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NICE decisions ▶Dronedarone for the treatment of non-permanent atrial fibrillation (updated December 2012) NICE TA197 Dronedarone (Multaq ®) is an option for the maintenance of sinus rhythm after successful cardioversion in paroxysmal or persistent atrial fibrillation which is not controlled by first-line therapy (usually including beta- blockers), and after alternative options have been considered in patients: . who have at least 1 of the following cardiovascular risk factors: hypertension requiring drugs of at least 2 different classes, diabetes mellitus, previous transient ischaemic attack, stroke or systemic embolism, left atrial diameter of 50 mm or greater, or age 70 years or older, and . who do not have left ventricular systolic dysfunction nor a history of, or current, heart failure. Patients who do not meet the above criteria who are currently receiving dronedarone should have the option to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta197
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→Appendix 1: antiarrhythmics
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▶Common or very common Asthenia. bradycardia. congestive heart failure. diarrhoea. gastrointestinal discomfort. nausea. QT interval prolongation. skin reactions. vomiting ▶Uncommon Photosensitivity reaction. respiratory disorders. taste altered ▶Rare or very rare Hepatic disorders. vasculitis SIDE-EFFECTS, FURTHER INFORMATION Liver injury Liver injury including life-threatening acute liver failure reported rarely; discontinue treatment if 2 consecutive alanine aminotransferase concentrations exceed 3 times upper limit of normal. Heart failure New onset or worsening heart failure reported. If heart failure or left ventricular systolic dysfunction develops, discontinue treatment. Pulmonary toxicity Interstitial lung disease, pneumonitis and pulmonary fibrosis reported. Investigate if symptoms such as dyspnoea or dry cough develop and discontinue if confirmed.
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Manufacturer advises avoid—toxicity in animal studies.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises avoid in severe impairment.
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Avoid if eGFR less than 30 mL/minute/1.73 m2.
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▶Ongoing monitoring should occur under specialist supervision. ▶Monitor for heart failure. ▶Perform ECG at least every 6 months—consider discontinuation if atrial fibrillation reoccurs. ▶Measure serum creatinine before treatment and 7 days after initiation—if raised, measure again after a further 7 days and consider discontinuation if creatinine continues to rise. ▶Monitor liver function before treatment, 1 week and 1 month after initiation of treatment, then monthly for 6 months, then every 3 months for 6 months and periodically thereafter.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Dronedarone (Non-proprietary) Dronedarone (as Dronedarone hydrochloride) 400 mg Dronedarone 400mg tablets | 20 tablet P £22.49– £22.50 DT = £22.50 | 60 tablet P £67.49–£67.50 ▶Multaq (Sanofi) Dronedarone (as Dronedarone hydrochloride) 400 mg Multaq 400mg tablets | 20 tablet P £22.50 DT = £22.50 | 60 tablet P £67.50 ANTIARRHYTHMICS › OTHER
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Heart failure Patients or their carers should be told how to recognise signs of heart failure and advised to seek prompt medical attention if symptoms such as weight gain, dependent oedema, or dyspnoea develop or worsen. Hepatic disorders Patients or their carers should be told how to recognise signs of liver disorder and advised to seek Cardiovascular system prompt medical attention if symptoms such as abdominal pain, anorexia, nausea, vomiting, fever, malaise, itching, dark urine, or jaundice develop.
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400 mg twice daily
First-line fragment. Read the complete Indications and Dose section above.
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