Acitretin (acitretin)

No dosing information is available for this tab.

Acitretin should be administered orally once daily with the main meal. (See Food under Pharmacokinetics: Absorption.)

No dosing information is available for this tab.

No dosing information is available for this tab.

Acitretin is not metabolized by hepatic microsomal enzymes.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Acitretin is contraindicated in females who are or may become pregnant during acitretin therapy or within at least 3 years following discontinuance of the drug. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Acitretin is contraindicated in patients with severely impaired renal or hepatic function. (See Hepatic Effects under Warnings/Precautions: Warnings, in Cautions.) The drug also is contraindicated in patients with chronic, abnormally elevated blood lipids. (See Effects on Lipoproteins under Warnings/Precautions: Warnings, in Cautions.)

Concomitant use of acitretin with methotrexate, tetracyclines, or vitamin A and/or other oral retinoids is contraindicated. (See Drug Interactions.)

The drug is contraindicated in patients with known hypersensitivity to acitretin, any ingredient in the formulation, or other retinoids.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 10% or more of patients receiving acitretin in clinical trials include cheilitis, alopecia, skin peeling, rhinitis, dry skin, nail disorder, pruritus, rigors, xerophthalmia, dry mouth, epistaxis, arthralgia, spinal hyperostosis, rash, hyperesthesia, paresthesia, paronychia, and skin atrophy. Many reported adverse effects resemble those associated with hypervitaminosis A.

Laboratory abnormalities reported include increased or decreased electrolytes, hematocrit, hemoglobin, and glucose; increased liver transaminases, uric acid, BUN, and total and LDL-cholesterol; and decreased HDL-cholesterol. (See Hepatic Effects under Warnings/Precautions: Warnings, in Cautions and also see Effects on Lipoproteins under Warnings/Precautions: Warnings, in Cautions.)

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy have not been established in pediatric patients.

Ossification of interosseous ligaments and tendons of the extremities, skeletal hyperostoses, decreases in bone mineral density, and premature epiphyseal closure have been reported in children receiving other systemic retinoids, including etretinate (no longer commercially available in US). A causal relationship has not been established between the use of acitretin and these effects, and it is unknown whether these occurrences are more severe or appear more frequently in children. However, the manufacturer states that there is special concern because of the implications for growth potential in this population.

Category X. (See Users Guide.) All pregnancies during acitretin therapy or within 3 years following drug discontinuance should be reported to Stiefel Laboratories at 888-500-3376 or to the FDA MedWatch Program at 800-FDA-1088. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Acitretin is distributed into milk; women receiving the drug should not breast-feed.

Acitretin dosage should be selected with caution in geriatric patients (usually starting at the low end of the dosage range) because of possible age-related decreased hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Clinical trial experience in patients 65 years of age or older is insufficient to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. (See Geriatric Patients under Dosage and Administration: Special Populations.)