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Basic Drug Info
Drug Name:Amiodarone Hydrochloride
Manufacturer:Bioniche Pharma USA LLC
Other Info:

Patients whose arrhythmias have been suppressed by Amiodarone Hydrochloride Injection may be switched to oral amiodarone HCl.

The optimal dose for changing from intravenous to oral administration of amiodarone HCl will depend on the dose of Amiodarone Hydrochloride Injection already administered, as well as the bioavailability of oral amiodarone HCl.

When changing to oral amiodarone HCl therapy, clinical monitoring is recommended, particularly for elderly patients.Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone; grapefruit juice should not be taken during treatment with oral amiodarone (see PRECAUTIONS, Drug Interactions).RECOMMENDATIONS FOR ORAL DOSAGE AFTER I.V.

INFUSION #Assuming a 720 mg/day infusion (0.5 mg/min).*Amiodarone Hydrochloride Injection is not intended for maintenance treatment. Duration ofAmiodarone I.V. Infusion# Initial Daily Dose ofOral Amiodarone HCI  <1 week800-1600 mg 1-3 weeks600-800 mg >3 weeks*400 mg The following table provides suggested doses of oral amiodarone HCl to be initiated after varying durations of Amiodarone Hydrochloride Injection administration.

These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.



Clinical Trials:


Indications and Usage

Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone HCl is indicated, but who are unable to take oral medication.

During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone HCl therapy (see DOSAGE AND ADMINISTRATION ).

Amiodarone Hydrochloride Injection should be used for acute treatment until the patient's ventricular arrhythmias are stabilized.

Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection may be safely administered for longer periods if necessary.
Ventricular Fibrillation -- A potentially lethal cardiac arrhythmia that is characterized by uncoordinated extremely rapid firing of electrical impulses (400-600/min) in HEART VENTRICLES. Such asynchronous ventricular quivering or fibrillation prevents any effective cardiac output and results in unconsciousness (SYNCOPE). It is one of the major electrocardiographic patterns seen with CARDIAC ARREST.

Tachycardia, Ventricular -- An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).

Ventricular arrhythmia -- Irregular heart beat resulting from a pathologic process in the cardiac ventricles.--2004

Contraindications
Amiodarone Hydrochloride Injection is contraindicated in patients with known hypersensitivity to any of the components of Amiodarone Hydrochloride Injection, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV block unless a functioning pacemaker is available.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Sinus bradycardia -- A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Warnings

Hypotension is the most common adverse effect seen with Amiodarone Hydrochloride Injection.

In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with Amiodarone Hydrochloride Injection.

Clinically significant hypotension during infusions was seen most often in the first several hours of treatment and was not dose related, but appeared to be related to the rate of infusion.

Hypotension necessitating alterations in Amiodarone Hydrochloride Injection therapy was reported in 3% of patients, with permanent discontinuation required in less than 2% of patients.Hypotension should be treated initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion.

The initial rate of infusion should be monitored closely and should not exceed that prescribed in DOSAGE AND ADMINISTRATION.In some cases, hypotension may be refractory resulting in fatal outcome (see ADVERSE REACTIONS, Postmarketing Reports).
Branded Drugs
The following US Branded drugs contain Amiodarone Hydrochloride


CORDARONE -- WYETH PHARMACEUTICALS INC

NEXTERONE -- PRISM PHARMACEUTICALS INC

PACERONE -- UPSHER SMITH LABORATORIES INC


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