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Overdosages of up to 14.4 g have been reported in the literature. No fatalities have been reported and all overdosed patients recovered without sequelae. There is no specific antidote for a thalidomide overdose. In the event of an overdose, the patient’s vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
[see BOX WARNING]
THALOMID can cause fetal harm when administered to a pregnant female [see WARNINGS AND PRECAUTIONS and Use In Specific Populations] . Thalidomide is contraindicated in females who are pregnant. Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose [see BOX WARNING]. Mortality at or shortly after birth has been reported in about 40% of infants. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. If pregnancy occurs during thalidomide treatment, the drug should be discontinued immediately.
THALOMID is contraindicated in patients who have demonstrated hypersensitivity to the drug or its components [see WARNINGS AND PRECAUTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/27/2017
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