Amiodarone hydrochloride

CLINICAL USE


Cardiac arrhythmias

DOSE IN NORMAL RENAL FUNCTION

  • Oral: 200 mg 3 times a day for 1 week, then

    twice a day for 1 week, then 200 mg daily
    maintenance dose or minimum required
    to control arrhythmia

  • IV: via central catheter – 5 mg/kg

    (maximum 1.2 g in 24 hours)

  • Ventricular arrhythmias or pulseless

    ventricular tachycardias: 300 mg over at
    least 3 minutes

    PHARMACOKINETICS


  • Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :
    681.8
  • %Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :
    96
  • %Excreted unchanged in urine &nbsp &nbsp :
    <5

  • Volume of distribution (L/kg) &nbsp &nbsp &nbsp :
    70–140

  • half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :
    20–100 days/
    Unchanged

    DOSE IN RENAL IMPAIRMENT


    GFR (mL/MIN)


  • 20 to 50 &nbsp &nbsp : Dose as in normal renal function
  • 10 to 20 &nbsp &nbsp : Dose as in normal renal function
  • <10 &nbsp &nbsp &nbsp &nbsp &nbsp :
    Dose as in normal renal function

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES


  • CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:
    Not dialysed. Dose as in normal renal function

  • HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :
    Not dialysed. Dose as in normal renal function
  • HDF/high flux &nbsp :
    Unknown dialysability. Dose as in
    normal renal function
  • CAV/VVHD &nbsp &nbsp &nbsp:
    Not dialysed. Dose as in normal renal function

    IMPORTANT DRUG INTERACTIONS


    Potentially hazardous interactions with other drugs

  • Anti-arrhythmics: additive effect and

    increased risk of myocardial depression;
    increased risk of ventricular arrhythmias
    with disopyramide – avoid; increased
    flecainide concentration – halve
    flecainide dose; increased procainamide
    concentration – avoid

  • Antibacterials: increased risk of

    ventricular arrhythmias with parenteral
    erythromycin, co-trimoxazole and
    moxifloxacin – avoid concomitant use

  • Anticoagulants: metabolism inhibited

    (increased anticoagulant effect)

  • Antidepressants: increased risk of

    ventricular arrhythmias with tricyclic
    antidepressants – avoid concomitant use

  • Anti-epileptics: phenytoin metabolism

    inhibited (increased plasma concentration)

  • Antihistamines: increased risk of

    ventricular arrhythmias with mizolastine
    – avoid

  • Antimalarials: increased risk of

    ventricular arrhythmias with chloroquine,
    hydroxychloroquine, mefloquine and
    quinine – avoid concomitant use; avoid
    concomitant use with artemether/
    lumefantrine

  • Antipsychotics: increased risk

    of ventricular arrhythmias with
    antipsychotics that prolong the QT
    interval; increased risk of ventricular
    arrhythmias with amisulpride, haloperidol,
    phenothiazines, pimozide or sertindole –
    avoid

  • Antivirals: increased risk of ventricular

    arrhythmias with amprenavir, nelfinavir
    and ritonavir – avoid concomitant use;
    concentration possibly increased by
    atazanavir; avoid with indinavir

  • Atomoxetine: increased risk of ventricular

    arrhythmias

  • Beta-blockers, diltiazem, verapamil:

    increased risk of bradycardia, AV block
    and myocardial depression; increased risk
    of ventricular arrhythmias with sotalol –
    avoid

  • Ciclosporin: increased levels of ciclosporin

    possible

  • Digoxin: increased plasma concentration

    (halve digoxin maintenance dose)

  • 5HT

    3 antagonists: increased risk of
    ventricular arrhythmias with dolasetron
    – avoid concomitant use; caution with
    tropisetron

  • Ivabradine: increased risk of ventricular

    arrhythmias – avoid concomitant use

  • Lipid-lowering drugs: increased risk

    of myopathy with simvastatin – do not
    exceed 20 mg of simvastatin.1

  • Lithium: increased risk of ventricular

    arrhythmias – avoid concomitant use

  • Pentamidine: increased risk of ventricular

    arrhythmias – avoid concomitant use

  • Grapefruit juice: may increase

    concentration of amiodarone – avoid
    concomitant use

    ADMINISTRATION


    Reconstition


    –

    Route

  • Oral, IV via central catheter or

    peripherally in veins with good blood flow

    Rate of Administration

  • 20–120 minutes (max 1.2 g in up to 500 mL

    glucose 5% in 24 hours)

    Comments

  • Add dose to 250 mL glucose 5%
  • Solutions containing less than 300 mg in

    500 mL glucose 5% should not be used, as
    unstable

  • Minimum volumes for central use only are

    up to 900 mg in 48–50 mL.

    OTHER INFORMATION

  • Amiodarone and desethylamiodarone

    levels can be monitored to assess
    compliance

  • In extreme clinical emergency, may be

    given by slow IV bolus using 150–300 mg
    in 10 to 20 mL glucose 5% over a minimum
    of 3 minutes with close monitoring.
    This should not be repeated for at least
    15 minutes

  • Incompatible with sodium chloride 0.9%.
  • Rapid IV administration has been

    associated with anaphylactic shock, hot
    flushes, sweating, and nausea

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