Acitretin Dosage

Usual Adult Dose for Psoriasis

Initial dose: 25 to 50 mg orally per day, given as a single dose with the main meal
Maintenance dose: 25 to 50 mg orally per day; dosage should be individualized according to patient's response

Renal Dose Adjustments

Severe renal impairment: Contraindicated

Liver Dose Adjustments

Severe liver impairment: Contraindicated

Precautions

Acitretin must not be used by female patients who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy.

Acitretin is contraindicated in patients with chronically abnormal elevated blood lipid values. Blood lipid measurements should be performed before acitretin is given and again at intervals of 1 to 2 weeks until the lipid response to the drug is established, which usually occurs within 4 to 8 weeks. Dietary modifications, reduction in acitretin dose, or drug therapy should be implemented to control significant elevations of triglycerides. If, despite these measures, hypertriglyceridemia and low HDL levels persist, acitretin therapy should be discontinued. In clinical trials, these effects were generally reversible upon discontinuation of therapy.

Because of the risk of hypertriglyceridemia, serum lipids must be closely monitored in high-risk patients and during long-term therapy. Patients with an increased tendency to develop hypertriglyceridemia include those with disturbances of lipid metabolism, diabetes mellitus, obesity, increased alcohol intake, or a familial history of these conditions.

Although no causal relationship has been established, postmarketing reports of acute myocardial infarction or thromboembolic events in patients on acitretin therapy have been documented. Additionally, serum triglycerides greater than 800 mg/dL have been associated with fatal fulminant pancreatitis. Therapy should be discontinued if hypertriglyceridemia cannot be controlled or symptoms of pancreatitis occur.

It is recommended that liver tests be performed prior to initiation of acitretin therapy, at 1 and 2 week intervals, and thereafter at relevant intervals as clinically indicated. Case reports of hepatitis have been reported. If hepatotoxicity is suspected during treatment, discontinue use of acitretin until etiology is determined.

Continuation of therapy should be discussed if ossification abnormalities, vertebral changes, or skeletal appendicular changes arise.

Acitretin has been reported to cause visual and ophthalmic disturbances. Patients are advised to discontinue acitretin and seek ophthalmologic evaluation if visual difficulties are experienced.

Pseudotumor cerebri (benign intracranial hypertension) has been associated with the use of acitretin and other retinoids. Some of the events involved concomitant use of tetracyclines; therefore, tetracyclines should be avoided while receiving acitretin. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea, vomiting, and visual disturbances. If these symptoms present, the patient should be examined for papilledema and the drug should be discontinued immediately. The patient should be referred to a neurologist for further diagnosis and care.

Depression, psychoses and rarely, suicidal ideation, self-injurious behavior, and aggressive and/or violent behaviors have been reported in patients taking acitretin. Patients should be counseled to stop taking acitretin and notify their physician immediately if they experience psychiatric symptoms.

Some patients receiving retinoid therapy have experienced problems with blood sugar control; therefore, blood sugar levels should be monitored carefully in diabetics. Additionally, new onset diabetes and diabetic ketoacidosis have been diagnosed during retinoid therapy.

Acitretin should be used with caution in the elderly population reflecting the decreased hepatic, cardiac function, and concomitant disease or other drug therapy. A two-fold increase in acitretin plasma concentrations was seen in elderly patients without a change in elimination half-life when compared to younger patients.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

When used with phototherapy, the dosage of phototherapy should be decreased, dependent on the patient's response.

Patients should be advised that they must not give their acitretin capsules to any other person.

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