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SUBUTEX (buprenorphine) sublingual tablet is an uncoated oval white flat beveled edged tablet, debossed with an alphanumeric word identifying the product and strength on one side. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP) . Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate.
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- Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol).
- Consider dose reduction of CNS depressants, SUBUTEX sublingual tablet, or both in situations of concomitant prescription.
- Store SUBUTEX sublingual tablet safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
- Chronic administration produces opioid-type physical dependence. Abrupt discontinuation or rapid dose taper may result in opioid withdrawal syndrome.
- Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.
- Caution patients about the risk of driving or operating hazardous machinery.
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