Miconazole.txt

CLINICAL USE

Antifungal agent

DOSE IN NORMAL RENAL FUNCTION

Oral gel: 5–10 mL in mouth, after food, 4 times daily

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :416.1

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :90

%Excreted unchanged in urine &nbsp &nbsp : 1

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :20

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :24/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:Unlikely to be significantly dialysed. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Anticoagulants: effect of coumarins enhanced

Antidepressants: avoid concomitant use with reboxetineAntidiabetics: concentration of sulphonylureas increased

Anti-epileptics: effect of phenytoin enhanced; possibly increased carbamazepine concentrationAntihistamines: avoid concomitant use with mizolastine, risk of ventricular arrhythmias

Antimalarials: avoid concomitant use with artemether and lumefantrine

Antipsychotics: increased risk of ventricular arrhythmias with pimozide – avoid concomitant use; possibly increased concentration of quetiapine – reduce quetiapine dose; possibly increased risk of ventricular arrhythmias with sertindole – avoid

Antivirals: concentration of saquinavir possibly increased

Ciclosporin: possibly increased ciclosporin concentration

Ergot alkaloids: increased risk of ergotism with ergotamine and methysergide– avoid concomitant useSirolimus: concentration increased by miconazoleStatins: possibly increased risk of myopathy with atorvastatin and simvastatin– avoid concomitant use with simvastatin

Tacrolimus: possibly increased tacrolimus concentration

ADMINISTRATION

Reconstition

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Route

Oral gel, topical

Rate of Administration

–

Comments

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OTHER INFORMATION

Miconazole is metabolised in the liver to inactive metabolites;

10 to 20

% of an oral dose is excreted in the urine as metabolites. About 50% of an oral dose may be excreted mainly unchanged in the faecesThere is little absorption through skin or mucous membranes when miconazole nitrate is applied topically50% removed during haemodialysis .