CLINICAL USE

Hypnotic

DOSE IN NORMAL RENAL FUNCTION

3.75–7.5 mg at night

PHARMACOKINETICS

  • Molecular weight                           : 388.8
  • %Protein binding                           : 45–80
  • %Excreted unchanged in urine     : <5
  • Volume of distribution (L/kg)       : 91.8–104.6 litres
  • half-life – normal/ESRD (hrs)      : 3.5–6.5/Unchanged

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

  • 20 to 50     : Dose as in normal renal function
  • 10 to 20     : Dose as in normal renal function
  • <10           : Start with lower dose

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                : Dialysed. Dose as in GFR <10 mL/min
  • HD                     : Dialysed. Dose as in GFR <10 mL/min
  • HDF/high flux   : Dialysed. Dose as in GFR <10 mL/min
  • CAV/VVHD      : Dialysed. Dose as in normal renal function

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugs

  • Antibacterials: metabolism inhibited by erythromycin and quinupristin/ dalfopristin; concentration significantly reduced by rifampicin
  • Antipsychotics: enhanced sedative effects
  • Antivirals: concentration possibly increased by ritonavir

    ADMINISTRATION

    Reconstition

    Route

    Oral

    Rate of Administration

    Comments

    OTHER INFORMATION

    It is recommended that elderly patients and those with severe renal disease should start treatment with 3.75 mg; however, accumulation has not been observed .

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