Prednisone 40 to 60 mg/day tapered over several weeks may be helpful in treating pulmonary toxicity.Postoperatively, occurrences of ARDS have been reported in patients receiving amiodarone therapy who have undergone either cardiac or noncardiac surgery. In patients, following discontinuation of chronic oral therapy, amiodarone hydrochloride has been shown to have a biphasic elimination with an initial 50% reduction of plasma levels after 2.5 to 10 days.

Both strengths of Pacerone tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, FD&C Red 40 (200 mg only) and FD&C Yellow 6. Corneal microdeposits are reversible upon reduction of dose or termination of treatment. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy Advise women that breastfeeding is not recommended during treatment with Pacerone tablets Advise patients to avoid grapefruit juice and St. John's Wort.Advise patients to seek medical attention if they experience the signs and symptoms of pulmonary toxicity, worsening arrhythmia, bradycardia, visual impairment, or hypo- and hyperthyroidism.This product's label may have been updated. x������ endstream endobj 84 0 obj <>stream Some reversal of discoloration may occur upon drug discontinuation.Patients on amiodarone therapy may be more sensitive to the myocardial depressant and conduction effects of halogenated inhalational anesthetics.The following serious adverse reactions are described in more detail in other sections of the prescribing information:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.At the usual maintenance dose (400 mg/day) and above, amiodarone causes adverse reactions in about three-fourths of all patients, resulting in discontinuation in 7% to 18%.In surveys of almost 5,000 patients treated in open U.S. studies and in published reports of treatment with amiodarone, the adverse reactions most frequently requiring discontinuation of amiodarone included pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. The development of maximal ventricular class III effects after oral amiodarone hydrochloride administration in humans correlates more closely with DEA accumulation over time than with amiodarone accumulation.Following single dose administration in 12 healthy subjects, amiodarone hydrochloride exhibited multi-compartmental pharmacokinetics with a mean apparent plasma terminal elimination half-life of 58 days (range 15 to 142 days) for amiodarone and 36 days (range 14 to 75 days) for the active metabolite (DEA). Although patients usually respond well to vigorous respiratory therapy, in rare instances the outcome has been fatal.Asymptomatic elevations of hepatic enzyme levels are seen frequently, but amiodarone can cause life-threatening hepatic injury. During long-term treatment, a blue-gray discoloration of the exposed skin may occur.

Breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state.Amiodarone and its metabolite have been shown to cross the placenta.

See "Before taking Pacerone tablets, tell your healthcare provider about all of your medical conditions, including if you:Take your dose of Pacerone tablets the same way each time, either with or without food. 5 WARNINGS AND PRECAUTIONS 5.1 Serious Rash, including Stevens-Johnson Syndrome Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.Administer amiodarone consistently with regard to meals Pacerone tablets, 100 mg, are peach, round, flat-faced, uncoated tablets, debossed with "P" on one side, and "U-S" above "144" on the other side.Pacerone tablets, 200 mg, are pink, round, flat-faced, scored, uncoated tablets, debossed with "PBecause of the long half-life of amiodarone (15 to 142 days) and its active metabolite desethylamiodarone (14 to 75 days), adverse reactions and drug interactions can persist for several weeks following amiodarone discontinuation Amiodarone may cause a clinical syndrome of cough and progressive dyspnea accompanied by functional, radiographic, gallium-scan, and pathological data consistent with pulmonary toxicity.

Monitor heart rate in patients taking or recently discontinuing amiodarone when starting antiviral treatment In patients with implanted defibrillators or pacemakers, chronic administration of antiarrhythmic drugs may affect pacing or defibrillation thresholds. Neither amiodarone nor DEA is dialyzable.Although no dosage adjustment for patients with renal, hepatic, or cardiac abnormalities has been defined during chronic treatment with oral amiodarone, close clinical monitoring is prudent for elderly patients and those with severe left ventricular dysfunction.Amiodarone hydrochloride was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. Regular ophthalmic examination, including funduscopy and slit-lamp examination, is recommended during administration of amiodarone Corneal microdeposits appear in the majority of adults treated with amiodarone. Therefore, at the inception of and during amiodarone treatment, pacing and defibrillation thresholds should be assessed.Amiodarone may cause fetal harm when administered to a pregnant woman. There may be a continued increase in effect for longer periods still.

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