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Depo Provera

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

DEPO-PROVERA CI (medroxyprogesterone acetate), when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

Following a single 150 mg IM dose of DEPO-PROVERA Contraceptive Injection, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL. The levels then decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of DEPO-PROVERA Contraceptive Injection is approximately 50 days.

Women with lower body weights conceive sooner than women with higher body weights after discontinuing DEPO-PROVERA Contraceptive Injection.

The effect of hepatic and/or renal disease on the pharmacokinetics of DEPO-PROVERA Contraceptive Injection is unknown.



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