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Central nervous system agent
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Skeletal muscle relaxant
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Spasticity resulting from multiple sclerosis; spinal cord injuries, other spinal cord diseases; cerebral spasticity.
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(Adults) Individual titration required. Begin with 5 mg 3 times daily, increase by 5 mg every 3 days. Usual dose range 40 to 80 mg/day. Max 80 mg/day. Use lowest effective dose, before or after meals.
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Category C.
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Drowsiness, dizziness, weakness, fatigue, confusion, Insomnia, headache, nausea, Constipation, urinary frequency, CNS Depression, CV collapse, Nasal Congestion, increased AST and Alkaline phosphatase levels, repiratory failure, pruritus.
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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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