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Depakote (Divalproex sodium)
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Central nervous system agent
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Anticonvulsant
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Manic episodes associated with bipolar disorder; simple and complex seizures; complex partial seizures; prophylaxis of Migraine Headaches.
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250-750 mg/day before or after meal.
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Category X
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Nausea, somnolence, dizziness, vomiting, accidental injury, abdominal pain, upset stomach, rash, Diarrhea, increased appetite, tremor, weight gain, back pain, hair loss.
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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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