Tadalafil – kdc

CLINICAL USE

Treatment of erectile dysfunction

DOSE IN NORMAL RENAL FUNCTION

10 to 20 : mg, 30 minutes to 12 hours before sexual activity

PHARMACOKINETICS

Molecular weight :389.4

%Protein binding :94

%Excreted unchanged in urine : 36

Volume of distribution (L/kg) :63 litres

half-life – normal/ESRD (hrs) :17.5/ Increased

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : Dose as in normal renal function

10 to 20 : 10 mg initially and use with caution

<10 : 10 mg initially and use with caution

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD :Unlikely to be dialysed. Dose as in GFR <10 mL/min

HD :Not dialysed. Dose as in GFR <10 mL/min

HDF/high flux :Unlikely to be dialysed. Dose as in GFR <10 mL/min

CAV/VVHD :Unlikely to be dialysed. Dose as in GFR 10 to 20 mL/min

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugsAlpha-blockers: enhanced hypotensive effect – avoid concomitant useNicorandil: possibly enhanced hypotensive effect – avoid concomitant use

Nitrates: enhanced hypotensive effect– avoid concomitant use

ADMINISTRATION

Reconstition

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Route

Oral

Rate of Administration

–

Comments

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OTHER INFORMATION

Maximum dosing frequency is once daily Due to lack of trial data, maximum recommended dose is 10 mg in severe renal impairment; in practice a higher dose may be used with cautionProtein binding is not affected by renal impairment.

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