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Zoladex 10.8 mg
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.
A report of an anaphylactic reaction to synthetic GnRH (Factrel) has been reported in the medical literature. ZOLADEX is contraindicated in those patients who have a known hypersensitivity to LHRH, LHRH agonist analogues or any of the components in ZOLADEX.
ZOLADEX 10.8 mg (goserelin acetate implant) implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. For female patients requiring treatment with goserelin, refer to the prescribing information for ZOLADEX 3.6 mg implant.
ZOLADEX is contraindicated in women who are or may become pregnant while receiving the drug. In studies in rats and rabbits, ZOLADEX increased preimplantation loss, resorptions, and abortions (see Pregnancy section). In rats and dogs, ZOLADEX suppressed ovarian function, decreased ovarian weight and size, and led to atrophic changes in secondary sex organs. Further evidence suggests that fertility was reduced in female rats that became pregnant after ZOLADEX was stopped. These effects are an expected consequence of the hormonal alterations produced by ZOLADEX in humans. If a patient becomes pregnant during treatment, the drug must be discontinued and the patient must be apprised of the potential risk for loss of the pregnancy due to possible hormonal imbalance as a result of the expected pharmacologic action of ZOLADEX treatment. In animal studies, there was no evidence that ZOLADEX possessed the potential to cause teratogenicity in rabbits; however, in rats the incidence of umbilical hernia was significantly increased with treatment. (See Pregnancy, Teratogenic Effects.)
Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.
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