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ACCUTANE (ISOTRETINOIN) CAPSULES: OVERDOSAGE

The oral LD50 of Accutane (Isotretinoin) is greater than 4000 mg/kg in rats and mice ( > 600 times the recommended clinical dose of 1.0 mg/kg/day after normalization of the rat dose for total body surface area and > 300 times the recommended clinical dose of 1.0 mg/kg/day after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (653 times the recommended clinical dose of 1.0 mg/kg/day after normalization for total body surface area). In humans, overdosage has been associated with facial flushing, vomiting, cheilosis, headache, abdominal pain, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects.

Accutane causes serious birth defects at any dosage. Female patients of childbearing potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus. Nonpregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling. Educational materials for such patients can be obtained by calling the manufacturer. Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for 1 month after the overdose. All patients with isotretinoin overdose should not donate blood for at least 1 month.

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