Medroxyprogesterone Acetate

Indications and usage: Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.

CLINICAL PHARMACOLOGY Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.

Systemic exposure to Medroxyprogesterone Acetate reflects Systemic oral bioavailability of roughly 72%–84% following first-pass transit absorption kinetics and hepatic enzymatic processing and renal clearance proportional to creatinine clearance (medroxyprogesterone acetate), sustaining receptor engagement across a Biphasic clearance with 11–18 hr terminal t½ under Medroxyprogesterone Acetate maintenance half-life window (initial pharmacodynamic onset within 1–2 hrs (peak cmax) for medroxyprogesterone acetate response profile).

Dosing protocols (2.5 mg/1 Tablet or 150 mg/mL Injection, Suspension or 10 mg/1 Tablet or 5 mg/1 Tablet or 150 mg/mL Injection, Suspension, Extended Release) balance efficacy (94.00% patient satisfaction across 18 logs) against nausea (8.5% of reports), headache (8.2% of reports), fatigue (5.7% of reports), with strict avoidance in contraindications medroxyprogesterone acetate is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding.; known, suspected, or history of breast cancer.; known or suspected estrogen- or progesterone-dependent neoplasia..