Lupron Depot Pediatric
In early clinical trials using leuprolide acetate in adult patients, doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
In rats, subcutaneous administration of leuprolide acetate as a single dose 333 times the recommended human pediatric dose, expressed on a per body weight basis, resulted in dyspnea, decreased activity, and local irritation at the injection site. There is no evidence at present that there is a clinical counterpart of this phenomenon.
In cases of overdosage, standard of care monitoring and management principles should be followed.
- Hypersensitivity to GnRH, GnRH agonists or any of the excipients in LUPRON DEPOT-PED. Reports of anaphylactic reactions to GnRH agonists have been reported in the medical literature.
- All formulations of LUPRON DEPOT may cause fetal harm if administered to a pregnant woman. When LUPRON DEPOT was administered subcutaneously to rabbits it produced a dose related increase in major fetal abnormalities, and fetal mortality. The possibility exists that spontaneous abortion may occur if the drug is administered during pregnancy. LUPRON DEPOT-PED is contraindicated in women who are or may become pregnant. If this drug is inadvertently used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Last reviewed on RxList: 10/21/2011
Additional Lupron Depot Pediatric Information
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