Lupron (Leuprolide Acetate Injection) Drug Information: Overdosage and Contraindications

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May 27, 2012

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Prostate Cancer »

What is the prostate gland?

The prostate gland is an organ that is located at the base or outlet (neck) of the urinary bladder. (See the diagram that follows.) The gland surrounds the first part of the urethra. The urethra is the passage through which urine drains from the bladder to exit from the penis. One function of the prostate gland is to help control urination by pressing directly against the part of the urethra that it surrounds. The main function of the prostate gland is to produce some of the substances that are found in normal semen, such as minerals and sugar. Semen is the fluid that transports the sperm to assist with reproduction. A man can manage quite well, however, without his prostate gland. (See the section on surgical treatment for prostate cancer.)

In a young man, the normal prostate gland is the size of a walnut (<30g). During normal aging, however, the gland usually grows larger. This hormone-related enlargement with aging is called b...

Read the Prostate Cancer article »

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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 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

LUPRON (leuprolide acetate injection) INJECTION is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs or any of the excipients in LUPRON (leuprolide acetate injection) INJECTION: Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.
LUPRON (leuprolide acetate injection) is contraindicated in women who are or may become pregnant while receiving the drug. LUPRON (leuprolide acetate injection) may cause fetal harm when administered to a pregnant woman. Therefore, the possibility exists that spontaneous abortion may occur if the drug is administered during pregnancy. If this drug is administered during pregnancy or if the patient becomes pregnant while taking any formulation of LUPRON (leuprolide acetate injection) , the patient should be apprised of the potential hazard to the fetus.

Last reviewed on RxList: 3/3/2011
This monograph has been modified to include the generic and brand name in many instances.