Paricalcitol.txt

CLINICAL USE

Vitamin D analogue:Treatment and prevention of secondary hyperparathyroidism associated with chronic renal failure

DOSE IN NORMAL RENAL FUNCTION

IV: Give dose every other day or post dialysis; dose is dependent on PTH levels. See SPC for detailsOral: 1–4 mcg either daily or 3×/week according to PTH levels

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :416.6

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :>99

%Excreted unchanged in urine &nbsp &nbsp : 0 (16% as metabolites)

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :17–25 litres (6 litres in haemodialysis patients)

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :15 (oral 5–7)/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

None known

ADMINISTRATION

Reconstition

–

Route

IV, oral

Rate of Administration

Not less than 30 seconds

Comments

–

OTHER INFORMATION

Monitor calcium and phosphate levels at least monthly, more frequently during dose titrationParicalcitol solution for injection contains 30% v/v of propyleneglycol as an excipient. Isolated cases of central nervous system depression, haemolysis, and lactic acidosis have been reported as toxic effect associated with propyleneglycol administration at high doses. Although they are not expected to be found with paricalcitol administration (as propyleneglycol is eliminated during the dialysis process), the risk of toxic effect in overdosing situations has to be taken into accountParicalcitol injection contains 20% v/v of ethanol (alcohol). Each dose may contain up to 1.3 g ethanol. Harmful for those suffering from alcoholism.

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