Rythma Dosage/Direction for Use

Tablet: In patients with ventricular arrhythmias, adjustment to the antiarrhythmic requires careful cardiologic monitoring and may only be carried out if cardiologic emergency equipment is available and monitoring control possible. During treatment, check-tests should be made at regular intervals [eg, standard electrocardiogram (ECG) at intervals of 1 month or long-term ECG at intervals of 3 months and possibly exercise ECG].
Therapy should be reviewed if individual parameters deteriorate eg, prolongation of QRS time or QT time by >25% or PQ time by >50% or QT prolongation to >500 ms or increase in the number or severity of arrhythmias.
As saturation dose, 600 mg amiodarone HCl is given for 8-10 days (equivalent to 3 tablets of amiodarone 200 mg) per day. In some cases, dosages of up to 1200 mg amiodarone HCl (equivalent to 6 tablets of amiodarone HCl 200 mg) may become necessary per day. Afterwards, reduction to a maintenance dose, usually 200 mg amiodarone HCl (equivalent to 1 tablet of amiodarone HCl 200 mg) for 5 days per week may be initiated.
In some cases, higher dosages of 200-600 mg amiodarone HCl (equivalent to 1-3 tablets of amiodarone HCl 200 mg) per day are required during long-term therapy.
For the treatment of children, the dosage should be adjusted to the body surface area or to the body weight.
Special Note: As most of adverse reactions are dose-dependent, the lowest effective maintenance dose should be administered.
IV: Amiodarone should only be used in a special care unit with continuous monitoring of blood pressure and ECG. It should be administered only by physicians who are experienced in the treatment of fatal arrhythmias and are totally familiar with the risks and benefits of amiodarone therapy.
Carefully adjust dosage according to individual requirements and response, patient tolerance, and the patient's general condition and cardiovascular status.
The recommended IV Amiodarone HCI starting dose over the first 24 hours is approximately 1000 mg, administered by the infusion regimen as follows. (See Table 1.)

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After the first 24 hours, continue a maintenance infusion rate of 0.5 mg/min (i.e., 720 mg over 24 hours).
In the event of breakthrough episodes of ventricular fibrillation or hemodynamically unstable ventricular tachycardia, supplemental amiodarone hydrochloride infusions of 150 mg administered over 10 minutes at a rate of 15 mg/minute may be given.
Clinical trials on IV Amiodarone HCI reported that a maintenance infusion of up to 0.5 mg/minute can be administered with caution for 2-3 weeks, regardless of patient's age, renal function or left ventricular function. There has been limited experience on the use of IV Amiodarone HCI for longer than 3 weeks.
Administration: Tablet: It should be taken unchewed during or after meals together with sufficient liquid. The attending physician decides on the duration of administration.
Injection: IV Amiodarone should never be administered via a peripheral vein. It should always be administered exclusively as an infusion through a central venous catheter. Injection via the peripheral venous route, even at a very slow rate can cause local effects such as superficial phlebitis, and may aggravate hypotension, heart failure, myocardiopathy, or severe respiratory insufficiency.
For infusions lasting >1 hour, the concentration should not exceed 2 mg/mL unless administered via a central venous catheter. Infusions lasting >2 hours must be administered in polyolefin or glass bottles containing D₅W. Use of evacuated glass containers for admixing amiodarone is not recommended as incompatibility with a buffer in the container may cause precipitation.
Amiodarone injection should only be administered using a volumetric infusion pump. An in-line filter should be used during administration.
Polyvinyl chloride (PVC) tubing should be used during IV administration. The recommended dosing regimens have taken into account the amount of amiodarone adsorbed to PVC tubing.
Conversion from IV to Oral Dosage: Use IV amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Patients whose arrhythmias have been successfully controlled with IV Amiodarone may be transferred to oral therapy. The optimal dose for changing from IV to oral administration will depend on the IV dose already administered, as well as the bioavailability of oral amiodarone. When changing to oral therapy, clinical monitoring is recommended, particularly for elderly patients. Table 2 as follows provides suggested doses of oral amiodarone to be initiated after varying durations of IV administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the IV and oral routes, based on 50% bioavailability of oral amiodarone. (See Table 2.)

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