Absorica

OVERDOSE

In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects.

Absorica™ causes serious birth defects at any dosage (see BOXED CONTRAINDICATIONS AND WARNINGS). Female patients of childbearing potential who present with Absorica™ overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the BOXED CONTRAINDICATIONS AND WARNINGS. Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in WARNINGS AND PRECAUTIONS. 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 Absorica™ overdose should not donate blood for at least 1 month.

CONTRAINDICATIONS

Pregnancy

Absorica™ can cause fetal harm when administered to a pregnant woman. Major congenital malformations, spontaneous abortions, and premature births have been documented following pregnancy exposure to isotretinoin in any amount and even for short periods of time. Absorica™ is contraindicated in females who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus [see Use In Specific Populations].

Hypersensitivity

Hypersensitivity to this product (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 6/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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