No

Retinoid-like Compound

Treatment of severe psoriasis (includes erythrodermic and pustular types) and other disorders of keratinization

X

Pregnancy; retinoids are known to cause severe birth defects in a very high percentage of infants exposed to them in utero

1. The patient has severe psoriasis or other severe disorders of keratinization

2. The patient is reliable in understanding and carrying out instructions

3. The patient is able to comply with mandatory contraceptive measures

4. The patient has received, and acknowledged understanding of, a careful oral and printed explanation of the hazards of fetal exposure to acitretin and the risk of possible contraception failure; this explanation may include showing a line drawing to the patient of an infant with the characteristic external deformities resulting from retinoid exposure during pregnancy

Concomitant administration of vitamin A and other systemic retinoids must be avoided due to the risk of possible additive toxic effects

The concomitant administration of methotrexate and etretinate has been associated with hepatitis, a similar increased hepatitis risk may be expected with the combined use of acitretin and methotrexate

Preliminary studies indicated that acitretin does not influence the endogenous progesterone plasma concentrations induced by oral contraceptives

Concomitant administration of phenprocoumon and acitretin does not alter the hypothrombinemic effect of phenprocoumon or the plasma disposition of acitretin

The pharmacokinetics of acitretin and digoxin are not altered by concomitant multiple dose regimens of these two drugs

Concomitant administration of cimetidine did not alter the oral bioavailability of acitretin or the isomerization to its 13-cis form; single oral doses of acitretin did not affect the steady-state plasma concentration or renal clearance of cimetidine

Limited data which could not be duplicated, indicated that acitretin treatment either increased insulin sensitivity directly or interacted with glyburide to do so; careful supervision of diabetic patients under treatment with acitretin is recommended

Adults: Oral: Individualization of dosage is required to achieve maximum therapeutic response while minimizing side effects

Maintenance doses of 25 to 50 mg/day may be given after initial response to treatment; the maintenance dose should be based on clinical efficacy and tolerability; it may be necessary in some cases to increase the dose to a maximum of 75 mg/day

None reported

None reported

Capsule: 10 mg, 25 mg