The pharmacologic properties of ZOLADEX and its mode of administration make accidental or intentional overdosage unlikely. There is no experience of overdosage from clinical trials. Animal studies indicate that no increased pharmacologic effect occurred at higher doses or more frequent administration. Subcutaneous doses of the drug as high as 1 mg/kg/day in rats and dogs did not produce any nonendocrine related sequelae; this dose is greater than 400 times that proposed for human use. If overdosage occurs, it should be managed symptomatically.

ZOLADEX is contraindicated in those patients who have a known hypersensitivity to LHRH, LHRH agonist analogues or any of the components in ZOLADEX.

ZOLADEX is contraindicated in women being treated for endometriosis who are or may become pregnant while receiving the drug. ZOLADEX can cause fetal harm when administered to a pregnant woman. Effects on reproductive function, as a result of antigonadotrophic properties of the drug, are expected to occur on chronic administration.

Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy. There are no adequate and well-controlled studies in pregnant women using ZOLADEX. If this drug is used during pregnancy, or the patient being treated for endometriosis becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant.

For a description of findings in animal reproductive toxicity studies, see WARNINGS.

ZOLADEX is contraindicated in women who are breast feeding (see PRECAUTIONS: Nursing Mothers).

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