Applies to the following strength(s): 50 mg/mL ; 200 mg ; 300 mg ; 100 mg ; 400 mg ; 150 mg/100 mL-D5% ; 900 mg/500 mL-D5% ; 450 mg/250 mL-D5% ; 360 mg/200 mL-D5%
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Arrhythmias
Initial dose (IV): 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:
150 mg over the first 10 minutes (15 mg/min),
followed by 360 mg over the next 6 hours (1 mg/min).
Maintenance infusion: 540 mg over the remaining 18 hours (0.5 mg/min).
Initial dose (PO): Loading doses of 800 to 1600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs.
When adequate arrhythmia control is achieved, or if side effects become prominent, the dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Some patients may require up to 600 mg/day. Amiodarone may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a twice daily dose.
Usual Pediatric Dose for Supraventricular Tachycardia
less than 1 month:
Limited data available: oral loading dose: 10 to 20 mg/kg/day orally in 2 divided doses for 7 to 10 days; dosage should then be reduced to 5 to 10 mg/kg/day once daily and continued for 2 to 7 months; this protocol was used in 50 infants (less than 9 months of age) and neonates (as young as 1 day of life); intravenous loading dose: 5 mg/kg given over 60 minutes; Note: Bolus infusion rates should generally not exceed 0.25 mg/kg/minute unless clinically indicated; most studies used bolus infusion time of 60 minutes to avoid hypotension; may repeat initial loading dose to a maximum total initial load: 10 mg/kg; do not exceed total daily bolus of 15 mg/kg/day.
less than 1 year: Initial dose: 600 to 800 mg/1.73 mÂ²/day orally for 4 to 14 days given in 1 to 2 divided doses/day.
Maintenance dose: 200 to 400 mg/1.73 mÂ²/day orally given once a day.
greater than 1 year: Initial dose: 10 to 15 mg/kg/day orally for 4 to 14 days given in 1 to 2 divided doses/day.
Maintenance dose: 5 to 10 mg/kg/day orally given once a day.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Dosage adjustment is probably necessary in substantial hepatic impairment. No specific guidelines available. If hepatic enzymes exceed 3 times normal or double in a patient with an elevated baseline, consider decreasing the dose or discontinuing amiodarone.
Dose should be reduced by up to 50% in substantial liver impairment.
According to the results of a retrospective study, amiodarone may be safety administered to patients with elevated baseline ALT, but close monitoring of liver function is recommended.
After the first 24 hours, the maintenance infusion rate of 0.5 mg/min should be continued utilizing a concentration of 1 to 6 mg/mL. In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone IV mixed in 100 mL of D5W may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.
Administration of amiodarone in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs. If side effects become excessive, the dose should be reduced.
Amiodarone is contraindicated in patients with cardiogenic shock, severe sinus node dysfunction resulting in sinus bradycardia, second or third degree atrioventricular block, or symptomatic sinus bradycardia in the absence of an adequately functioning pacemaker.
A dose reduction or discontinuation of amiodarone should be considered in patients who experience thyrotoxicosis and/or arrhythmia breakthrough or exacerbation of arrhythmia due to thyroid dysfunction, hypersensitivity pneumonitis, interstitial/alveolar pneumonitis, life-threatening arrhythmias due to amiodarone induced pulmonary toxicity, hepatic enzyme levels exceed three times normal, or doubles in patient with an elevated baseline, optic neuropathy and/or optic neuritis, symptomatic corneal microdeposits, and peripheral neuropathy.
Thyroid nodules and thyroid cancer has been reported in postmarketing experience.
There have been postmarketing reports of acute onset (days to weeks) pulmonary injury in patients receiving oral therapy with or without initial intravenous therapy. Findings include pulmonary infiltrates (on X-ray), alveolar hemorrhage, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Patients with preexisting pulmonary disease have a poorer prognosis if toxicity develops. The reports suggest that lower initial and maintenance dosing are associated with decreased incidence of amiodarone associated pulmonary toxicity.
Infusion rate related hypotension has been the most common adverse effect noted with intravenous amiodarone. Initial dosage and rate recommendations should not be exceeded.
Amiodarone is not removed by hemo- or peritoneal dialysis. A supplemental dose is not required.
Daily doses above 2100 mg are associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min.
Ophthalmic examinations have been recommended prior to initiation of therapy (i.e., baseline) and every 6 to 12 months or more frequently depending on clinical findings.
Thyroid dysfunction can occur in any patient and at any time during therapy with amiodarone including following discontinuation of therapy. For this reason thyroid function should be monitored prior to therapy and periodically thereafter, particularly in the elderly and in patients with a history of thyroid dysfunction. Abnormal thyroid function tests may persist for weeks or months after discontinuation of amiodarone.
Patients should receive a baseline chest X-ray and pulmonary function tests including diffusion capacity prior to initiation of therapy and ever 3 to 6 months thereafter.
Patients on relatively high maintenance doses should have their liver enzymes (SGOT and SGPT) monitored on a regular basis.
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