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Ortho Novum 10/11 (Norethindrone & ethinyl estradiol)
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Endocrine/Metabolic
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Sex hormone
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21-Day regimen: Take 1 tablet daily for 21 days, followed by 7 days off. Repeat as 28-day cycle. 28-Day regimen: Take 1 active tablet daily for 21 days, followed by 1 inert tablet for 7 days.
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Category X
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Most serious: Blood clots, High Blood Pressure, benign tumor of the liver. Most common: Nausea, vomiting, weight changes, breakthrough bleeding, breast pain, lethargy, thromboembolism, optic Neuritis, bowel ischemia, vaginal candidiasis, plasminogen, liver tumors, thyroid-binking globulin, erythema multiforme.
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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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