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Plaquenil (Hydroxychloroquine sulfate)
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Systemic anti-infective
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Antimalarial preparation
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Malaria, systematic lupus erythematosus, rheumatoid arthritis.
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(Adults) Lupus erythematosus: Initial dose 400 mg 1 or 2 times daily. Rheumatoid arthritis: 200-400 mg/day. Malaria prevention: 400 mg every 7 days 2 weeks before and 8 weeks after trip. Malaria treatment: Initially 800 mg, then 400 mg 6, 24, and 48 hours after 1st dose.
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Category X
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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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