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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)Wikipedia. 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 an 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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