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Lupron Depot 22.5

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Lupron Depot 22.5

Overdosage
Contraindications

OVERDOSE

In rats subcutaneous administration of 250 to 500 times the recommended human 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 early clinical trials with daily subcutaneous leuprolide acetate, 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.

CONTRAINDICATIONS

Hypersensitivity to GnRH, GnRH agonist analogs or any of the excipients in LUPRON DEPOT (leuprolide acetate for depot suspension injection) . Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.

LUPRON DEPOT (leuprolide acetate for depot suspension injection) is contraindicated in women who are or may become pregnant while receiving the drug. When administered on day 6 of pregnancy at test dosages of 0.00024, 0.0024, and 0.024 mg/kg (1/600 to 1/6 of the human dose) to rabbits, the monthly formulation of LUPRON DEPOT (leuprolide acetate for depot suspension injection) produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of the monthly formulation of LUPRON DEPOT in rabbits and with the highest dose in rats. The effects on fetal mortality are logical consequences of the alterations in hormonal levels brought about by this drug. Therefore, the possibility exists that spontaneous abortion may occur if the drug is administered during pregnancy.

Last reviewed on RxList: 6/2/2010
This monograph has been modified to include the generic and brand name in many instances.

Overdosage
Contraindications
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