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Suboxone(Buprenorphine & naloxone)
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Central nervous system agent
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Antidot
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Opioid dependence
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Adults: Dissolve under tongue; do not swallow tabs. Start when clear signs of opioid use; individualize based on type and degree of opioid dependence. Supervised administration(induction phase); Subutex 8 mg once on day 1 and Subutex 16 mg once on day 2. Unsupervised administration(maintenance phase): target dose is Suboxone 16 mg once daily; adjust in 2 mg or 4 mg increments; range 4-24 mg once daily.
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CATEGORY C
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Headache, withdrawal syndrome, pain, upset stomach, trouble sleeping, weakness, dizziness on standing
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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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