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Endocrine/Metabolic
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Bisphophonate
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Prevention and treatment of osteoporosis in postmenopausal women and glucocorticoid-induced osteoporosis. Treatment of Paget's disase of bone.
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Adults: swallow whole. Take in the AM with a full glass plain water at least 30 minutes before other food or drink; take in upright position; do not lie down for at least 30 minutes afterwards. Postmenopausal: 5 mg once daily or 35 mg once weekly. Paget's: 30 mg once daily for 2 months; may retreat after a 2-month post-treatment evaluation period.
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CATEGORY C
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Unusual severe stomach pain, mild nausea, gas, diarrhea, or constipation, bone, muscle, or joint pain, esophagitis, gastric ulcer, allergic reaction
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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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