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Premarin (Conjugated estrogens)
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Endocrine/Metabolic
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Sex hormone
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Abnormal uterine bleeding, castration and primary ovarian failure, Osteoporosis, female hypogonadism, vasomotor menopausal symptoms, atrophic vaginitis or kraurosis vulvae, palliative treatment of inoperable prostatic cancer, menopause.
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0.625-1.25 mg/day, before or after meals.
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Category X
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Breakthrough bleeding, spotting, breast tenderness or enlargement, nausea, vomiting, Bloating, abdominal cramps, Seizures, thromboembbolism, worsening of myopis or astigmatism, pancreatitis, increased risk of Endometrial Cancer, increased PT and INR and clotting factors VII to X and norepinephrine-induced platelet aggregability, hepatic adenoma, weight changes.
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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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