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Regranex (Becaplermin 0.01%) Gel
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Dermatological agent
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Wound healing agent
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Diabetic neuropathic ulcers
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Adults and teens over 16 years: spread the gel over entire ulcer to thickness of about 1/16 inch, and cover the treated area with a saline-moistened dressing and leave in place for 12 hours. The dressing should then be removed and the area rinsed with water or saline to remove any residual gel. Cover the area again with a clean saline dressing (no gel) for the rest of the day. Reevaluate if ulcer does not decrease in size by about 30% after 10 weeks. Your doctor will give you directions about how to apply and how much gel to spread.
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Category C
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rash, irritation at the site of application
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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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