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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (L's) » Leuprolide



DESCRIPTION

Lupron, Lupron Depot, and Lupron Depot-Ped (leuprolide acetate) are 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).

Lupron Injection: Lupron is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 ml multiple-dose vial containing 5 mg/ml of leuprolide acetate, sodium chloride for tonicity adjustment, 9 mg/ml of benzyl alcohol as a preservative and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid.

Lupron Injection (For Pediatric Use): Lupron Injection is a sterile, aqueous solution intended for daily subcutaneous injection.

A 2.8 ml multiple dose vial containing leuprolide acetate (5 mg/ml), sodium chloride (6.3 mg/ml) for tonicity adjustment, benzyl alcohol as a preservative (9 mg/ml), and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid.

Lupron Depot 3.75 mg and Lupron Depot 7.5 mg: Lupron Depot is supplied in a vial containing sterile lyophilized microspheres, which when mixed with diluent, become a suspension, which is intended as a monthly intramuscular injection.

Lupron Depot 3.75 mg: The single-dose vial of Lupron Depot contains leuprolide acetate (3.75 mg), purified gelatin (0.65 mg), DL-lactic and glycolic acids copolymer (33.1 mg), and D-mannitol (6.6 mg). The accompanying ampule of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.

During the manufacturing process of Lupron Depot, acetic acid is lost, leaving the peptide.

Lupron Depot 7.5 mg: The single-dose vial of Lupron Depot contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The accompanying ampule of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75 mg), polysorbate 80 (1.5 mg), water for injection, USP, and acetic acid, NF to control pH.

During the manufacture of Lupron Depot, acetic acid is lost leaving the peptide.

Lupron Depot-Ped: Lupron Depot-Ped is supplied in a vial containing sterile lyophilized microspheres, which when mixed with diluent, become a suspension, intended as a single intramuscular injection.

The single-dose vial of Lupron Depot-Ped contains, respectively for each dosage strength, leuprolide acetate (7.5/11.25/15 mg), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The accompanying ampule of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75 mg), polysorbate 80 (1.5 mg), water for injection, USP, and acetic acid, NF to control pH.

During the manufacture of Lupron Depot-Ped, acetic acid is lost leaving the peptide.

CATEGORIES, BRAND NAMES

CATEGORIES: Cancer, Prostatic; Endometriosis; Pregnancy Category X; FDA Approved 1985 Apr; Orphan Drugs

FDA Drug Class: Anterior Pituitary/Hypothalmic Function; Antineoplastics; Estrogens/Progestins; Hormones/Hormonal Mechanisms; Pharmaceutical Aids

BRAND NAMES: Carcinil; Enanton Depot; Enantone; Enantone Depot; Enantone LP; Enantone SR; Leuplin; Leuplin Depot; Lucrin; Lucrin Depot; Lucrin Depot Inj; Luprolex; Lupron; Lupron Depot; Procren; Procren Depot; Procrin; Procrin Depot; Tapros
(Foreign brand names outside U.S. in italics)





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