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Endocrine/Metabolic
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Sex hormone
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(Adults) Endometriosis: Starting dose is 800 mg in 2 divided doses, then titrate downward. Begin therapy during menstruation and continue for 3 to 6 months (up to 9 months if necessary). Fibrocystic breast disease: 100 to 400 mg/day in 2 divided doses. Begin therapy during menstruation. Usual duration is 4 to 6 months.
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Category X
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Menstrual disturbances, flushing, sweating, vaginal dryness and irritation, reduced breast size, nervousness.
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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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