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Provera (Medroxyprogesterone acetate)
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Endocrine/Metabolic
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Sex hormone
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Abnormal uterine bleeding from hormonal imbalance, secondary amenorrhea, endometrial or renal carcinoma, paraphilia in men, contraception in women, absence of menstruation, abnormal uterine bleeding due to hormonal imbalance, hormone replacement in menopause.
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(Adults) Absent menstruation 10mg/day for 5 to 10 days. Abnormal uterine bleeding: Beginning on 16th or 21st day of menstrual cycle, 5 to 10mg/day 5 to 10 days. Menopause: 2.5 mg/day.
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Category X
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Breast tenderness, acne, changes in body hair, breakthrough bleeding, spotting, changed menstrual flow, weight change, mental Depression, Pulmonary Embolism, thromboembolism, exophthalmos, abnormal secretions, cholestatic jaundice, changes in weight, melasma.
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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