![]() Although patients usually respond well to vigorous respiratory therapy, in rare instances the outcome has been fatal.Ĭases of optic neuropathy and optic neuritis, usually resulting in visual impairment and sometimes permanent blindness, have been reported in patients treated with amiodarone and may occur at any time during therapy. Postoperatively, occurrences of ARDS have been reported in patients receiving amiodarone hydrochloride therapy who have undergone either cardiac or noncardiac surgery. Prednisone 40 to 60 mg/day tapered over several weeks may be helpful in treating pulmonary toxicity.Īdult Respiratory Distress Syndrome (ARDS) Consider alternative antiarrhythmic therapy if the patient experiences signs or symptoms of pulmonary toxicity. Repeat history, physical exam, and chest X-ray every 3 to 6 months or if symptoms occur. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride therapy is initiated. ![]() ![]() ![]() Rates of pulmonary toxicity have been reported to be as high as 17% and is fatal in about 10% of cases. Pulmonary toxicity secondary to amiodarone hydrochloride may result from either indirect or direct toxicity as represented by hypersensitivity pneumonitis (including eosinophilic pneumonia) or interstitial/alveolar pneumonitis, respectively. Administration of amiodarone hydrochloride tablets in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs.Īmiodarone hydrochloride may cause a clinical syndrome of cough and progressive dyspnea accompanied by functional, radiographic, gallium-scan, and pathological data consistent with pulmonary toxicity. Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.Īdminister amiodarone hydrochloride tablets consistently with regard to meals Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases. Initiate amiodarone hydrochloride in a clinical setting where continuous electrocardiograms and cardiac resuscitation are availableĭosage must be individualized based on severity of arrhythmia and response. Discontinue amiodarone hydrochloride if the patient experiences signs or symptoms of clinical liver injuryĪmiodarone hydrochloride can exacerbate arrhythmias. ![]() Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Repeat history, physical exam, and chest X-ray every 3 to 6 monthsĪmiodarone hydrochloride can cause hepatoxicity, which can be fatal. Pulmonary toxicity has been fatal about 10% of the time. WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITYĪmiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicityĪmiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. FULL PRESCRIBING INFORMATION: CONTENTS * BOXED WARNING 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Persistence of Adverse Effects 5.2 Pulmonary Toxicity 5.3 Hepatic Injury 5.4 Worsened Arrhythmia 5.5 Visual Impairment and Loss of Vision 5.6 Thyroid Abnormalities 5.7 Bradycardia 5.8 Implantable Cardiac Devices 5.9 Fetal Toxicity 5.10 Peripheral Neuropathy 5.11 Photosensitivity and Skin Discoloration 5.12 Surgery 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. ![]()
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