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Cordarone (amiodarone hydrochloride)

BOXED WARNING

Use only in patients w/ the indicated life-threatening arrhythmias because of potentially fatal toxicities, including pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis). Liver injury is common, usually mild, and evidenced only by abnormal liver enzymes. Overt liver disease may occur, and has been fatal. May exacerbate arrhythmia. Significant heart block or sinus bradycardia reported. Patients must be hospitalized while LD is given, and a response generally requires at least 1 week, usually 2 or more. Maintenance-dose selection is difficult and may require dosage decrease or discontinuation of treatment.

THERAPEUTIC CLASS

Class III antiarrhythmic

DEA CLASS

RX

INDICATIONS

Treatment of life-threatening recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia when these have not responded to adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.

ADULT DOSAGE

Ventricular Tachycardia

Documented, life-threatening recurrent hemodynamically unstable ventricular arrhythmia that has not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated

LD: 800-1600mg/day for 1-3 weeks; give in divided doses w/ meals for total daily dose ≥1000mg or if GI intolerance occurs
Titrate: After control is achieved or w/ prominent side effects, reduce to 600-800mg/day for 1 month
Maint: 400mg/day; up to 600mg/day

Use lowest effective dose

Ventricular Fibrillation

Documented, life-threatening recurrent ventricular arrhythmia that has not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated

LD: 800-1600mg/day for 1-3 weeks; give in divided doses w/ meals for total daily dose ≥1000mg or if GI intolerance occurs
Titrate: After control is achieved or w/ prominent side effects, reduce to 600-800mg/day for 1 month
Maint: 400mg/day; up to 600mg/day

Use lowest effective dose

DOSING CONSIDERATIONS

Elderly
Start at the lower end of dosing range

Other Important Considerations
Avoid grapefruit juice

ADMINISTRATION

Oral route

Give LD in the hospital
Administer consistently w/ regard to meals
May be administered as a single dose, or in patients w/ severe GI intolerance, as a bid dose

HOW SUPPLIED

Tab: 200mg* *scored

CONTRAINDICATIONS

Cardiogenic shock; severe sinus-node dysfunction, causing marked sinus bradycardia; 2nd- or 3rd-degree atrioventricular (AV) block; when episodes of bradycardia have caused syncope (except when used w/ a pacemaker).

WARNINGS/PRECAUTIONS

D/C and institute steroid therapy if hypersensitivity pneumonitis occurs. Reduce dose or d/c if interstitial/alveolar pneumonitis occurs and institute appropriate treatment. The risk of arrhythmia exacerbation may be increased when other risk factors are present (eg, electrolytic disorders). Correct hypokalemia, hypomagnesemia, or hypocalcemia whenever possible before initiating therapy; monitor electrolyte and acid-base balance in patients experiencing severe/prolonged diarrhea. Chronic administration w/ implanted defibrillators/pacemakers may affect pacing and defibrillating thresholds. Amiodarone-induced hyperthyroidism may result in thyrotoxicosis and/or the possibility of arrhythmia breakthrough or aggravation. D/C or reduce dose if LFTs are >3X normal or double in patients w/ elevated baseline. Optic neuropathy and/or optic neuritis, usually resulting in visual impairment, reported. May cause fetal harm in pregnancy and neonatal hypo/hyperthyroidism. May develop reversible corneal microdeposits (eg, visual halos, blurred vision), photosensitivity, and peripheral neuropathy (rare). May cause hypo/hyperthyroidism and myxedema coma; monitor particularly in elderly and w/ history of thyroid nodules, goiter, or other thyroid dysfunction. Thyroid nodules/cancer reported. Hypotension reported upon discontinuation of cardiopulmonary bypass during open-heart surgery (rare). Adult respiratory distress syndrome (ARDS) reported w/ either cardiac or noncardiac surgery. Lab test interactions may occur. May be contraindicated w/ corneal refractive laser surgery devices. Caution w/ severe left ventricular dysfunction.

ADVERSE REACTIONS

Pulmonary toxicity, arrhythmia exacerbation, liver injury, overt liver disease, heart block/sinus bradycardia, malaise, fatigue, involuntary movements, peripheral neuropathy, constipation, poor coordination and gait, N/V, anorexia, photosensitivity.

DRUG INTERACTIONS

See Dose Modification. Risk of interactions exists not only w/ concomitant medication, but also w/ drugs administered after discontinuation of therapy due to long and variable T1/2. The risk of arrhythmia exacerbation may be increased w/ concomitant antiarrhythmics or other interacting drugs. Monitor electrolyte and acid-base balance w/ concomitant diuretics and laxatives, systemic corticosteroids, amphotericin B (IV), or other drugs affecting electrolyte levels. Avoid concomitant use of drugs that prolong the QT interval (eg, Class I and III antiarrhythmics, lithium, certain phenothiazines); increases risk of torsades de pointes. Concomitant use of drugs w/ depressant effects on the sinus and AV node (eg, digoxin, β-blockers, verapamil, diltiazem, clonidine) can potentiate the electrophysiologic and hemodynamic effects of therapy; monitor HR. May increase sensitivity to myocardial depressant and conduction effects of halogenated inhalation anesthetics. Drugs/substances that inhibit CYP3A (eg, certain protease inhibitors, loratadine, cimetidine, trazodone) may decrease metabolism and increase serum concentrations of therapy. Grapefruit juice may increase levels. Concomitant use of CYP3A inducers (eg, rifampin, St. John's wort) may lead to decreased serum concentrations and loss of efficacy; consider serial measurement of amiodarone serum concentration during concomitant use of drugs affecting CYP3A activity. Reduced serum levels and T1/2 w/ cholestyramine. Inhibits P-gp, CYP1A2, CYP2C9, CYP2D6, and CYP3A and may increase levels of their substrates. Rhabdomyolysis/myopathy reported w/ HMG-CoA reductase inhibitors that are CYP3A substrates; limit simvastatin dose to 20mg/day and lovastatin dose to 40mg/day. Lower initial/maintenance doses of other CYP3A substrates (eg, atorvastatin) may be required. Elevated SrCr reported w/ cyclosporine; monitor cyclosporine drug levels and renal function in patients taking both drugs. May increase levels of cyclosporine, quinidine, and procainamide. May inhibit metabolism of quinidine, procainamide, and flecainide. Initiate any added antiarrhythmic drug at a lower than usual dose w/ monitoring. May increase levels of digoxin; d/c or reduce dose by approx 50% upon amiodarone initiation. May inhibit metabolism of lidocaine, resulting in increased lidocaine levels; sinus bradycardia and seizure reported in patients receiving concomitant lidocaine. Reduce warfarin dose by 1/3-1/2 and monitor PT closely. Ineffective inhibition of platelet aggregation reported w/ clopidogrel. May result in elevated serum levels of dabigatran etexilate. Fentanyl may cause hypotension, bradycardia, and decreased cardiac output. Increased steady-state levels of phenytoin reported; monitor phenytoin levels. May impair metabolism of dextromethorphan, leading to increased serum levels w/ chronic (>2 weeks) amiodarone treatment. Antithyroid drugs' action may be delayed in amiodarone-induced thyrotoxicosis. Radioactive iodine is contraindicated w/ amiodarone-induced hyperthyroidism.

PREGNANCY AND LACTATION

Category D, not for use in nursing.

MECHANISM OF ACTION

Class III antiarrhythmic; prolongs myocardial cell-action potential duration and refractory period, and causes noncompetitive antagonism of α- and β-adrenoceptors.

PHARMACOKINETICS

Absorption: Slow and variable; bioavailability (approx 50%); Tmax=3-7 hrs (single dose). Distribution: Vd=60L/kg; plasma protein binding (approx 96%); crosses the placenta; found in breast milk. Metabolism: Liver via CYP3A, CYP2C8; desethylamiodarone (DEA) (major metabolite). Elimination: Bile, urine; T1/2=58 days, 36 days (DEA).

ASSESSMENT

Assess for cardiogenic shock, severe sinus node dysfunction causing marked sinus bradycardia, 2nd- or 3rd-degree AV block, life-threatening arrhythmias, renal/hepatic impairment, thyroid dysfunction, hypersensitivity to the drug (including iodine), pregnancy/nursing status, and possible drug interactions. Assess pacing and defibrillation thresholds in patients w/ implanted defibrillators or pacemakers. Obtain chest x-ray, pulmonary function tests (including diffusion capacity), and physical exam. Correct hypokalemia, hypomagnesemia, or hypocalcemia whenever possible.

MONITORING

Monitor for pulmonary toxicities, worsened arrhythmia, sinus bradycardia, heart block, photosensitivity, and other adverse reactions. Perform history, physical exam, and chest x-ray every 3-6 months. Monitor LFTs and thyroid function tests. Monitor pacing and defibrillation thresholds in patients w/ implanted defibrillators or pacemakers. Peri/postoperative monitoring for patients undergoing general anesthesia and for patients w/ ARDS recommended. Perform regular ophthalmic examination, including funduscopy and slit-lamp examination.

PATIENT COUNSELING

Inform about benefits and risks of therapy. Advise to report any adverse reactions to physician. Counsel to take ud and not to take w/ grapefruit juice. Advise to avoid prolonged sunlight exposure and to use sun-barrier cre or protective clothing. Advise that corneal refractive laser surgery is contraindicated w/ therapy. Instruct to notify physician if pregnant/nursing.

STORAGE

20-25°C (68-77°F). Protect from light.

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