isotretinoin

CLINICAL USE

Treatment of nodulo-cystic and conglobate acne, and severe acne which has failed to respond to an adequate course of systemic antibiotics

DOSE IN NORMAL RENAL FUNCTION

0.5–1 mg/kg daily in 1–2 divided doses initially. Maximum cumulative dose: 150 mg/kg per courseTopically: 1–2 times daily

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :300.4

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :99.9

%Excreted unchanged in urine &nbsp &nbsp : As metabolites

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :No data

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :

10 to 20

/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 : Initial dose 10 mg daily and slowly increase as tolerated up to 1 mg/kg daily. See ‘Other Information’

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Not dialysed. Dose as in GFR <10 mL/min

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

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

CAV/VVHD &nbsp &nbsp &nbsp:Not dialysed. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Antibacterials: possible increased risk of benign intracranial hypertension with tetracyclines – avoid concomitant use

ADMINISTRATION

Reconstition

–

Route

Oral, topical (0.05% gel)

Rate of Administration

–

Comments

–

OTHER INFORMATION

Since the drug is highly protein bound, it is not expected to be significantly removed by dialysisWatch for signs of vitamin A toxicity .

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