«USES Actions MPA (17α-hydroxy-6-α-methylprogesterone acetate) is a progestogen and a derivative of progesterone. MPA induces responses in ...»
Clinical trial data BMD changes in adult women In a controlled, clinical study adult women using DEPO-PROVERA (150 mg IM) for up to 5 years for contraception showed spine and hip mean BMD decreases of 5% to 6%, compared to no significant change in BMD in the control group. The decline in BMD was more pronounced during the first 2 years of use, with smaller declines in subsequent years. Mean changes in lumbar spine BMD of -2.9%, -4.1%, -4.9%, -4.9% and -5.4% after 1, 2, 3, 4 and 5 years, respectively, were observed. Mean decreases in BMD of the total hip and femoral neck were similar.
After stopping use of DEPO-PROVERA (150 mg IM), there was partial recovery of BMD toward baseline values during the 2-year post-therapy period. A longer duration of treatment was associated with a slower rate of BMD recovery (see WARNINGS AND PRECAUTIONS).
BMD changes in adolescent females (12 to 18 years) Preliminary results from an ongoing, open-label clinical study of DEPO-PROVERA (150 mg IM every 12 weeks for up to 5 years) in adolescent females (12 to 18 years) for contraception also showed that DEPO-PROVERA use was associated with a significant decline in BMD from baseline. The mean decrease in lumbar spine BMD was 4.2% after 5 years; mean decreases for the total hip and femoral neck were 6.9% and 6.1%, respectively. In contrast, most adolescent girls will significantly increase bone density during this period of growth following menarche. Preliminary data from a small number of adolescents have shown partial recovery of BMD during the 2-year follow-up period (see WARNINGS AND PRECAUTIONS).
Excipients Depo-Provera contains the following excipients: hydrochloric acid, macrogol 3350, polysorbate 80, sodium chloride, methyl 4-hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide and Water for Injections.
NAME AND ADDRESSPfizer New Zealand Ltd P O Box 3998 Auckland, New Zealand, 1140.
Toll Free Number: 0800 736 363.
DATE OF PREPARATION29 December 2014.
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