Lupron Depot-Ped

Product manufactured by Abbvie Inc.

Application Nr Approved Date Route Status External Links
NDA020263 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lupron Depot-Ped Is Indicated In The Treatment Of Children With Central Precocious Puberty (Cpp). Cpp Is Defined As Early Onset Of Secondary Sexual Characteristics (Generally Earlier Than 8 Years Of Age In Girls And 9 Years Of Age In Boys) Associated With Pubertal Pituitary Gonadotropin Activation. It May Show A Significantly Advanced Bone Age That Can Result In Diminished Adult Height. Prior To Initiation Of Treatment A Clinical Diagnosis Of Cpp Should Be Confirmed By Measurement Of Blood Concentrations Of Luteinizing Hormone (Lh) (Basal Or Stimulated With A Gnrh Analog), Sex Steroids, And Assessment Of Bone Age Versus Chronological Age. Baseline Evaluations Should Include Height And Weight Measurements, Diagnostic Imaging Of The Brain (To Rule Out Intracranial Tumor), Pelvic/testicular/adrenal Ultrasound (To Rule Out Steroid Secreting Tumors), Human Chorionic Gonadotropin Levels (To Rule Out A Chorionic Gonadotropin Secreting Tumor), And Adrenal Steroid Measurements To Exclude Congenital Adrenal Hyperplasia. Lupron Depot-Ped Is A Gonadotropin Releasing Hormone (Gnrh) Agonist Indicated In The Treatment Of Children With Central Precocious Puberty. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Leuprolide Acetate

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