Soriatane (Acitretin) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

Drug Interactions:

Ethanol:

 Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and Clinical Pharmacology: Pharmacokinetics).

Overdosage:

In the event of acute overdosage, Soriatane must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A, ie, headache and vertigo. The acute oral toxicity (LD₅₀) of acitretin in both mice and rats was greater than 4000 mg/kg.

In one reported case of overdose, a 32-year-old male with Darier’s disease took 21 × 25 mg capsules (525 mg single dose). He vomited several hours later but experienced no other ill effects.

All female patients of childbearing potential who have taken an overdose of Soriatane must:

1) Have a pregnancy test at the time of overdose; 2) Be counseled as per the boxed CONTRAINDICATIONS AND WARNINGS and Precautions sections regarding birth defects and contraceptive use for at least 3 years’ duration after the overdose.

Contraindications:

Pregnancy Category X

(See boxed CONTRAINDICATIONS AND WARNINGS)

Soriatane is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed Warnings: Hepatoxicity, Warnings: Lipids and Possible Cardiovascular Effects, and Precautions).

An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with Soriatane is also contraindicated (see Precautions: Drug Interactions).

Since both Soriatane and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see Warnings: Pseudotumor Cerebri).

Soriatane is contraindicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids.