Lupron Depot 22.5

DRUG DESCRIPTION

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:

Lupron Depot (leuprolide acetate for depot suspension injection) 
  (leuprolide acetate) Structural Formula Illustration

LUPRON DEPOT (leuprolide acetate for depot suspension injection) 3 Month 22.5 mg is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY THREE MONTHS (84 days).

The front chamber of LUPRON DEPOT (leuprolide acetate for depot suspension injection) 3 Month 22.5 mg prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.

During the manufacture of LUPRON DEPOT (leuprolide acetate for depot suspension injection) 3 Month 22.5 mg, acetic acid is lost, leaving the peptide.



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